Selarsdi is a human interleukin-12 and -23 antagonist indicated for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.

The approval was based on a totality of evidence, including data from a phase 3 study (ClinicalTrials.gov Identifier: NCT04930042) that compared the efficacy and safety of Selarsdi to the reference product Stelara in patients with moderate to severe plaque psoriasis. Results showed the products were therapeutically equivalent, meeting the primary endpoint for psoriasis area and severity index percent improvement from baseline to week 12.

The approval was also supported by data from a phase 1 study (ClinicalTrials.gov Identifier: NCT04744363) that compared the pharmacokinetic, safety, tolerability and immunogenicity of Selarsdi administered as a single 45mg/0.5mL subcutaneous injection to Stelara. Findings showed bioequivalence between Selsardi and the reference product.

Selarsdi is supplied as 45mg/0.5mL and 90mg/mL single-dose prefilled syringes. The product is expected to be available in February 2025.

Kimberly Feng, MD, from Brigham and Women’s Hospital in Boston, and colleagues investigated whether biosimilar competition is associated with lower OOP spending for patients using biologics. The analysis included national claims data (Optum Clinformatics Data Mart) for 190,364 individuals (younger than 65 years of age) with outpatient claims for 1 of 7 clinician-administered biologics (filgrastim, infliximab, pegfilgrastim, epoetin alfa, bevacizumab, rituximab, and trastuzumab) from January 2009 through March 2022.

The researchers found that annual OOP costs increased before and after biosimilar availability. Compared with the year before biosimilar competition, 2 years after the start of biosimilar competition, the adjusted odds ratio of nonzero annual OOP spending was 1.08 and average nonzero annual spending was 12% higher. Claims for biosimilars were more likely than reference biologics to have nonzero OOP costs (adjusted odds ratio, 1.13) but had lower mean nonzero OOP costs (adjusted mean ratio, 0.92). There was variance by drug.

“Findings of this study suggest that the introduction of biosimilar competition did not systematically lower patient OOP spending on biologics, highlighting the need for targeted policy interventions to ensure that savings from biosimilar competition improves affordability for patients,” the authors write.

Abstract/Full Text

Editorial

The Food and Drug Administration (FDA) has approved Tyenne^® (tocilizumab-aazg), the first biosimilar to Actemra^® (tocilizumab) for both intravenous (IV) and subcutaneous (SC) administration.

Tyenne, an interleukin-6 (IL-6) receptor antagonist, is indicated for the treatment of:

• Adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more disease-modifying anti-rheumatic drugs (DMARDs);
• Adults with giant cell arteritis; and
• Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis.

A biosimilar is a biological product that is approved based on a demonstration that it is highly similar to an already-approved biological product with no clinically meaningful differences in safety and efficacy from the reference product. The approval of Tyenne was supported by data from a phase 3 study (ClinicalTrials.gov Identifier: NCT04512001) that compared tocilizumab-aazg to an EU-approved tocilizumab in patients with moderately to severely active rheumatoid arthritis. 

Findings showed both products were equally effective based on clinically relevant decreases from baseline in Disease Activity Score-28 Joint Count-erythrocyte sedimentation rate at week 24 (primary endpoint). Similarity was also demonstrated with regard to safety and immunogenicity. 

“Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the US is a moment of great pride for Fresenius Kabi,” said Dr Michael Schönhofen, Fresenius Kabi President Biopharma. “The FDA’s approval of our tocilizumab biosimilar is a breakthrough in bringing high-quality, affordable, and accessible autoimmune treatment options to patients and health care providers.”

Tyenne is supplied as a 20mg/mL single-dose vial (80mg/4mL, 200mg/10mL, or 400mg/20mL) for further dilution prior to IV infusion. It is also available as a ready-to-use, single-dose prefilled syringe (162mg/0.9mL) and a single-dose prefilled autoinjector (162mg/0.9mL) for SC injection.

In September 2023, the FDA had approved the first biosimilar to Actemra, Tofidence (tocilizumab-bavi). This product is administered as an IV infusion.

Jubbonti is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. The Jubbonti approval also includes a Risk Evaluation and Mitigation Strategy program designed to inform prescribers of the risk of severe hypocalcemia in patients with advanced kidney disease. 

Wyost is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

For this approval, the FDA reviewed a comprehensive clinical data package, which included data from the phase 3 ROSALIA trial (ClinicalTrials.gov Identifier: NCT03974100). The study compared denosumab-bbdz to the reference product (Prolia) in 527 postmenopausal women with osteoporosis. Study participants were randomly assigned to receive the biosimilar or the reference product for up to 78 weeks of treatment. Findings showed the biosimilar denosumab was comparable to the reference product with regard to pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity.

The availability of Jubbonti and Wyost is still unclear as ongoing patent litigation precludes Sandoz from launching the products at this time.

The Food and Drug Administration (FDA) has approved the first generic version of Rectiv^® (nitroglycerin) ointment, 0.4%.

Cosette Pharmaceuticals’ Nitroglycerin Ointment 0.4% is a nitrate vasodilator indicated for the treatment of moderate to severe pain associated with chronic anal fissure. The ointment contains 4mg of nitroglycerin per 1g of ointment and is applied intra-anally.

The product is supplied in a 30g tube and will be available soon, according to the Company.

Nitroglycerin ointment should be avoided in patients who are using phosphodiesterase type 5 inhibitors (eg, sildenafil, vardenafil and tadalafil) as these agents may potentiate the hypotensive effects of organic nitrates. Additionally, the product is contraindicated  in patients with severe anemia or in those with increased intracranial pressure.

Fluorometholone ophthalmic suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. The treatment is administered as 1 drop into the conjunctival sac 2 to 4 times daily. During the first 24 to 48 hours, the dosing frequency may be increased to 1 application every 4 hours. 

Patients should be reevaluated if signs/symptoms fail to improve after 2 days. Intraocular pressure should be monitored if the product is used for 10 days or longer.

Amneal’s Fluorometholone Ophthalmic Suspension 0.1% is supplied as a sterile, white to off-white homogenous suspension in 10mL bottles containing 5mL of product and in 15mL bottles containing 10mL of product.

Avzivi is a vascular endothelial growth factor inhibitor indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
• Unresectable, locally advanced, recurrent or metastatic nonsquamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
• Recurrent glioblastoma in adults.
• Metastatic renal cell carcinoma in combination with interferon alfa.
• Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.

The approval was based on a comprehensive data package that included a pharmacokinetic study (ClinicalTrials.gov Identifier: NCT05865574) in healthy individuals, as well as a phase 3 comparative study (ClinicalTrials.gov Identifier: NCT03329911) in patients with advanced nonsquamous non-small cell lung cancer.

“The global phase 3 clinical trial has confirmed that Avzivi is highly similar to Avastin in terms of efficacy, safety and immunogenicity,” said professor Li Zhang, leading investigator for global phase 3 study of Avzivi. “The approval of Avzivi by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option.”

Podofilox Gel is an antimitotic drug indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). Treatment results in necrosis of visible wart tissue. 

The gel is applied twice daily with the applicator tip or finger for 3 consecutive days, then discontinued for 4 consecutive days. This 1 week cycle may be repeated until there is no visible wart tissue or for a maximum of 4 cycles. 

The generic product from Padagis is expected to be available in December 2023.

The Food and Drug Administration (FDA) has approved Wezlana (ustekinumab-auub), an interchangeable biosimilar to Stelara (ustekinumab).

Wezlana is a human interleukin-12 and -23 antagonist. In adults, Wezlana is indicated for the treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn disease, and moderately to severely active ulcerative colitis. In children 6 years of age and older, Wezlana is approved for the treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, and for active psoriatic arthritis.

According to the FDA, an interchangeable product is a biological agent that is approved based on data demonstrating that it is highly similar to an approved reference product and that there are no clinically meaningful differences between the products. The interchangeable product can be expected to produce the same clinical result as the reference product in any given patient. The biosimilar may be substituted for the reference product at the pharmacy similar to how generics are substituted for brand name drugs.

The approval of Wezlana was based on a comprehensive review of scientific evidence that showed the product was highly similar to Stelara with no clinically meaningful differences in safety, purity, or potency. Moreover, chemical and biological tests and biological assays showed that Wezlana and Stelara were similar in structural and functional features.

The biosimilar was also evaluated in a phase 3 study (ClinicalTrials.gov Identifier: NCT04607980) in adult patients with moderate to severe plaque psoriasis. Study participants were randomly assigned to receive Wezlana (n=281) or Stelara (n=282). The primary endpoint of the study was the percent improvement from baseline to week 12 in psoriasis area severity index (PASI). Findings showed no clinically meaningful differences between the groups; mean difference in percent improvement between Wezlana and Stelara was 0.14, which was within the prespecified margins. 

“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” said Nikolay Nikolov, MD, director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.”

Adalimumab-adbm injection, a biosimilar to Humira^® (adalimumab), has been made available by Boehringer Ingelheim.

Adalimumab-adbm injection is an interchangeable biosimilar and can be substituted for the reference product without requiring a prescription change. The substitution may occur at the pharmacy similar to how generics are substituted for brand name drugs. According to the Company, Adalimumab-adbm injection has been priced at an 81% discount to Humira.  

Adalimumab-adbm injection is indicated for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderately to severely active Crohn disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis, moderate to severe hidradenitis suppurativa, and noninfectious intermediate, posterior, and panuveitis.

The product is also approved to treat moderately to severely active Crohn disease in children 6 years of age and older, as well as moderately to severely active polyarticular juvenile idiopathic arthritis in children 2 years of age and older.

Adalimumab-adbm injection is a citrate-free formulation and is supplied as 40mg/0.8mL, 20mg/0.4mL and 10mg/0.2mL prefilled syringes and as a 40mg/0.8mL prefilled autoinjector.

In July 2023, Boehringer Ingelheim launched a branded version of adalimumab-adbm called Cyltezo^®. This product will remain available at a 5% discount to Humira.

“Biosimilars are intended to contribute to the economic sustainability of health care systems, and it is our hope that this dual pricing approach will contribute to that sustainability, improve access to Adalimumab-adbm and help meet the varied needs of people with a variety of chronic inflammatory diseases,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.

The Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi), the first biosimilar to tocilizumab (Actemra^®).

Tofidence, an interleukin-6 receptor antagonist, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more disease-modifying antirheumatic drugs; for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older; and for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

The FDA approval was based on data demonstrating that Tofidence is highly similar to the reference product, with no clinically meaningful differences.  To support the approval, Biogen conducted a phase 1 study evaluating the pharmacokinetics, safety, and immunogenicity of Tofidence vs tocilizumab in healthy participants (ClinicalTrials.gov Identifier: NCT03606876), as well as a phase 3 study comparing the biosimilar to the reference product in patients with RA inadequately controlled by methotrexate (ClinicalTrials.gov Identifier: NCT03830203).

Findings from the phase 3 study showed similar efficacy between the Tofidence and tocilizumab groups. At week 12, 69% of patients in the biosimilar arm achieved an American College of Rheumatology 20 (ACR20) percent response (primary endpoint) compared with 65% of patients in the tocilizumab arm. At week 24, ACR20 response was achieved in 69% of the biosimilar arm and 68% of the tocilizumab arm. Comparable pharmacokinetic, safety and immunogenicity profiles were also reported.

“The approval of Tofidence in the US marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for health care systems and an increase in physician choice and patient access to biologics.”

Tofidence is supplied as a preservative-free solution in 20mg/mL single-dose vials (80mg/4mL, 200mg/10mL, 400mg/20mL). It is administered as an intravenous infusion following further dilution.

The Food and Drug Administration (FDA) has changed the therapeutic equivalence rating for Accord Healthcare’s generic tacrolimus oral capsules from AB to BX making it no longer recommended as automatically substitutable for the brand name drug, Prograf (tacrolimus) oral capsules.

Tacrolimus is indicated for the prevention of organ rejection in adults with allogeneic kidney, liver, heart, or lung transplants, in combination with other immunosuppressants. The FDA’s decision was based on new data from several FDA-funded studies that assessed concerns from the transplant community regarding the substitutability of FDA-approved generic tacrolimus oral capsules that were approved before 2012. 

According to study findings, Accord Healthcare’s tacrolimus oral capsules may deliver elevated peak blood concentrations compared with the brand name drug leading to an increased risk for toxicity. However, no significant differences were observed in the trough blood levels, indicating no increased risk for organ rejection. The FDA is not aware of any postmarketing issues regarding the product’s safety or efficacy.

While the therapeutic equivalence rating for Accord Healthcare’s tacrolimus oral capsules has been changed, the product is still approved and can be prescribed. The change means that the data are insufficient to show that the product provides the same therapeutic effect as Prograf. Patients currently being treated with Accord Healthcare’s tacrolimus oral capsules should not make changes to their treatment without consulting their health care provider. 

Generic tacrolimus oral capsules manufactured by other companies are not impacted by this issue. Other tacrolimus dosage forms are also not affected.

Adverse events or quality problems should be reported to the FDA’s MedWatch program.

(HealthDay News) — For 6 cardiovascular diseases (CVDs) examined, coverage of evidence-based medications varies by low-cost generic program (LCGP), drug, and condition, according to a study published online Sept. 5 in the Annals of Internal Medicine.

Ivy T. Ton, PharmD, from the Western University of Health Sciences in Pomona, California, and colleagues examined LCGPs’ coverage of evidence-based CVD medications in a cross-sectional study of 19 publicly available LCGPs in March and April 2023 in the United States. The proportion of LCGPs that offered evidence-based CVD medicines for 6 CVDs was examined according to 4 metrics (breadth, choice, high-quality evidence, and titratability).

The researchers found variation in the availability of CVD medication by program, drug, and CVD condition. Some of the programs had greater breadth and choice of coverage for most CVDs, while many had more focused coverage, and limited offerings were provided by others.

Angiotensin-converting enzyme inhibitors, β-blockers, thiazides, and moderate-intensity statins were offered by nearly all LCGPs, while lower availability was seen for higher-cost or lower-use generics, including antiplatelets and antiarrhythmics. For atrial fibrillation and heart failure, core pharmacotherapy coverage and choices were limited, while for hypertension and hyperlipidemia, they were widely available.

“Medication coverage in LCGPs varies widely for core, evidence-based CVD medications in all CVD conditions investigated, with differences in medication coverage options and strengths by program and condition,” the authors write. “Health care professionals should consider medication availability and LCGP-specific characteristics when recommending their use.”

One author disclosed ties to the pharmaceutical industry and one to the medical device industry.

Abstract/Full Text (subscription or payment may be required)

(HealthDay News) — For select generic medications, out-of-pocket (OOP) payments frequently exceed discount card pricing for 2 discount drug programs, according to a research letter published online Sept. 5 in the Annals of Internal Medicine.

Pranav M. Patel, PharmD, from the University of Toledo College of Pharmacy and Pharmaceutical Sciences in Ohio, and colleagues estimated the proportion and extent of OOP payments exceeding Amazon Prime and GoodRx Gold discount card pricing for commonly prescribed generic medications using data from the 2020 Medical Expenditure Panel Survey. The analysis focused on the 20 most prescribed generic medications in this dataset.

The researchers found that for about 20% and 43% of the prescriptions included in the analysis, OOP payments exceeded Amazon and GoodRx prices, respectively. For 40% and 79% of the prescriptions assumed to be in the deductible phase, OOP payments exceeded Amazon and GoodRx prices, respectively.

Assuming patients obtained their medications using Amazon and GoodRx discount cards, the estimated cumulative OOP cost savings amounted to about $969 million and $1.83 million, respectively. Of the cumulative savings, most were generated from 90-day prescriptions.

“Although some discount card programs may provide temporary relief for patients’ OOP costs on select generic medications, their dependence on pharmacy benefit managers for claims adjudication and access to contracted pharmacies hinders long-term solutions,” the authors write.

Abstract/Full Text (subscription or payment may be required)

The Food and Drug Administration (FDA) has approved Tyruko^® (natalizumab-sztn), a biosimilar to Tysabri (natalizumab).

Tyruko is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. This is the first biosimilar product indicated for treating relapsing forms of MS.

The approval was based on a robust data package that included phase I and phase 3 clinical studies. Findings from the phase 3 Antelope study (ClinicalTrials.gov Identifier: NCT04115488) in RRMS patients showed that the biosimilar product was equivalent in efficacy, safety and immunogenicity to the reference product.

“Today’s approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” said Sarah Yim, M, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.

Tyruko is also approved for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α.

Like the reference product, the prescribing information for Tyruko includes a Boxed Warning regarding the risk of progressive multifocal leukoencephalopathy (PML). Because of the risk of PML, Tyruko is only available through a restricted distribution program called the Tyruko REMS Program.  When initiating and continuing treatment, clinicians should consider whether the expected benefit of Tyruko is sufficient to offset the risk of PML.

Tyruko is supplied as a 300mg/15mL solution in a single-dose vial for dilution prior to infusion.

Vigadrone^® (vigabatrin), an AB-rated generic version of Sabril^®, is now available as a 500mg tablet in addition to the powder for oral solution formulation (500mg packets containing a granular powder for reconstitution).

Vigadrone is indicated for the treatment of refractory complex partial seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; it is not indicated as a first line agent.

It is also approved for infantile spasms as monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

Like Sabril, the prescribing information for Vigadrone includes a Boxed Warning regarding the risk of permanent vision loss and is only available under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program.

Vigadrone 500mg tablets are supplied in 100-count bottles.

Viatris announced the launch of Breyna (budesonide and formoterol fumarate dihydrate) inhalation aerosol, the first generic version of AstraZeneca’s Symbicort^®.

Breyna is a metered-dose inhaler containing a combination of budesonide, a corticosteroid, and formoterol, a long-acting beta₂ adrenergic agonist (LABA). The drug-device combination product is available in 160mcg/4.5mcg and 80mcg/4.5mcg dosage strengths.

The Food and Drug Administration (FDA) approved Breyna in March 2022 for the treatment of asthma in patients 6 years of age and older; and for maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The 160mcg/4.5 mcg is the only strength indicated for the treatment of COPD.

The Company will be offering a copay program for eligible patients in August 2023.

Padagis has announced the approval of a generic over-the-counter (OTC) naloxone hydrochloride nasal spray, a therapeutically equivalent version of Narcan^® nasal spray.

Naloxone hydrochloride nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The treatment reverses the effects of opioids, including respiratory depression, sedation, and hypotension.

“This first generic approval of an over-the-counter naloxone nasal spray highlights the innovation and execution capabilities of the Padagis team,” said Padagis President, Pamela Hoffman. “Padagis is committed to leveraging our resources and expertise to contribute to the national effort in addressing opioid overdose, a pressing public health issue.”

In March 2023, the Food and Drug Administration (FDA) approved Narcan (naloxone HCl) nasal spray as an OTC emergency treatment. The approval for nonprescription use was supported by more than 7 years of postmarketing data demonstrating the safety and efficacy of Narcan, along with human factors studies.

Endo International has announced the launch of Bivalirudin Injection in a ready-to-use 250mg/50mL single-use vial.

Bivalirudin is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention, including those with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. The ready-to-use formulation eliminates the need to prepare or transfer the product prior to administration, which may reduce the chance for preparation errors. 

Bivalirudin Injection is supplied as a ready-to-use, sterile solution in 250mg/50mL single-dose vials. The product is available in cartons containing either 1 or 10 vials.

“Hospital practitioners work hard to provide quality patient care while also meeting operational challenges,” said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. “With ready-to-use products like bivalirudin, we’re helping to deliver solutions that reduce complexity for health care providers—so they can focus on patient care.”

Fresenius Kabi has launched a 100mcg per 2mL presentation of Fentanyl Citrate Injection, USP in its Simplist ready-to-administer prefilled syringes.

The Simplist ready-to-administer prefilled syringe requires no assembly and is designed for efficient medication delivery and ease of use, to help eliminate steps where errors may occur. Fentanyl Citrate Injection may be administered via intravenous or intramuscular injection and is indicated for:

• Analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance and in the immediate postoperative period (recovery room) as the need arises.
• Use as an opioid analgesic supplement in general or regional anesthesia.
• Administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
• Use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

The preservative-free solution is supplied in single-dose prefilled syringes in 50mcg/mL and 100mcg/2mL dosage strengths. 

“Fresenius Kabi is pleased to add this presentation of Fentanyl to our portfolio of Simplist prefilled syringes, further demonstrating our commitment to patient safety and combating drug diversion,” said John Ducker, president and CEO of Fresenius Kabi USA. “By offering this critical care product in secure and convenient ready-to-administer packaging, we are helping frontline health care professionals administer this prescription safely and confidently by helping to minimize administration errors and reduce drug waste.”

Fentanyl citrate remains on the Food and Drug Administration’s list of agents currently in short supply.

Several biosimilar products to Humira^® (adalimumab), a tumor necrosis factor (TNF) blocker, have now been made commercially available.

These products include: 

• Abrilada^® (adalimumab-afzb; Pfizer): Indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. The citrate-free formulation is supplied in single-dose prefilled pens (Abrilada Pen; 40mg/0.8mL), single-dose prefilled syringes (40mg/0.8mL, 20mg/0.4mL, 10mg/0.2mL), and single-dose vials for institutional use only (40mg/0.8mL).
• Cyltezo^® (adalimumab-adbm; Boehringer Ingelheim): An interchangeable, citrate-free biosimilar to Humira, it is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa. The product is supplied as a 40mg/0.8mL single-dose prefilled pen (Cyltezo Pen) and in single-dose prefilled syringes in dosages of 40mg/0.8mL, 20mg/0.4mL, and 10mg/0.2mL. An interchangeable biosimilar product can be substituted for the reference product without requiring a prescription change; this substitution may occur at the pharmacy similar to how generics are substituted for brand name drugs.
• Hadlima^® (adalimumab-bwwd; Organon and Samsung Bioepis): Available in a low-concentration formulation (single-dose prefilled autoinjector [Hadlima PushTouch], single-dose prefilled syringe, and single-dose vial for institutional use only: 40mg/0.8mL) and a citrate-free, high-concentration formulation (single-dose prefilled syringe: 40mg/0.4mL). It is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
• Hulio^® (adalimumab-fkjp; Biocon Biologics): Available as a citrate-free, low-concentration formulation (40mg/0.8mL prefilled pens [Hulio Pen] and prefilled syringes; 20mg/0.4mL prefilled syringes). It is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
• Hyrimoz^® (adalimumab-adaz; Sandoz): Available as a low-concentration formulation (50mg/mL) and a citrate-free, high-concentration formulation (100mg/mL). It is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. It is supplied in single-dose prefilled pens (Sensoready Pen) and in single-dose prefilled syringes.
• Idacio^® (adalimumab-aacf; Fresenius Kabi USA): Available as a citrate-free, low-concentration formulation (single-dose prefilled pen [Idacio Pen] and single-dose prefilled syringe: 40mg/0.8mL). It is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.
• Yuflyma^® (adalimumab-aaty; Celltrion): Available as a citrate-free, high-concentration formulation (single-dose prefilled autoinjector, single-dose prefilled syringe, single-dose prefilled syringe: 40mg/0.4mL). It is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
• Yusimry^® (adalimumab-aqvh; Coherus BioSciences): Available as a citrate-free, low-concentration formulation (single-dose prefilled pen [Yusimry Pen] and single-dose prefilled syringe: 40mg/0.8mL). It is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Amjevita (adalimumab-atto), a citrate-free biosimilar to Humira, was also made available in the US earlier this year. The product is supplied in a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and in 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes.

The first generic version of Noxafil^® (posaconazole) injection has been made available by Endo International plc.

Posaconazole injection is an azole antifungal indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older; and for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft vs host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy, in patients 2 years of age and older.

Posaconazole injection is supplied in single-dose vials containing 300mg of posaconazole in 16.7mL of solution (18mg of posaconazole per mL).

“We’re pleased to provide choices to health care providers,” said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. “The first generic version of Noxafil^® injection does just that, while also strengthening our product portfolio and underscoring our reputation as a reliable, quality supplier.”

The Food and Drug Administration (FDA) has approved Yuflyma^® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free biosimilar to Humira^® (adalimumab).

Yuflyma is a tumor necrosis factor indicated for:

• Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA; may be used alone or with methotrexate (MTX) or other non-biologic DMARDs.
• Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older; may be used alone or with MTX.
• Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA; may be used alone or with non-biologic DMARDs.
• Ankylosing spondylitis (AS): reducing signs/symptoms in adult patients with active AS.
• Crohn disease (CD): moderately to severely active CD in patients 6 years of age and older.
• Ulcerative colitis (UC): moderately to severely active UC in adult patients.
• Plaque psoriasis: treating adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
• Hidradenitis suppurativa: moderate to severe hidradenitis suppurative in adult patients.

The approval of Yuflyma was based on data demonstrating that the biosimilar and reference product were similar with regard to efficacy, safety, and immunogenicity after 24 weeks and 52 weeks of treatment.

Yuflyma is supplied as 40mg/0.4mL in single-dose prefilled autoinjectors (Yuflyma AI) and single-dose prefilled syringes. The product is expected to be available in July 2023.

The Company is also seeking an interchangeability designation from the FDA, which is expected in the fourth quarter of 2024.

Udenyca^® (pegfilgrastim-cbqv), a biosimilar to Neulasta, is now available in a single-dose prefilled autoinjector device.

Udenyca is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

The Food and Drug Administration approved the new autoinjector presentation in March 2023. The approval was based on a clinical study demonstrating pharmacokinetic and pharmacodynamic bioequivalence as well as comparable safety (including immunogenicity) of Udenyca administered with the autoinjector vs the prefilled syringe.

Udenyca is now available as a 6mg/0.6mL preservative-free solution in a single-dose prefilled autoinjector and in a single-dose prefilled syringe. The prefilled autoinjector is not suitable for use in pediatric patients weighing less than 45kg. It delivers the entire contents (6mg in 0.6mL) in a single injection and is not adjustable.

Cyltezo^® (adalimumab-adbm), an interchangeable biosimilar to Humira^® (adalimumab), will soon be available in a new autoinjector device, in addition to the prefilled syringe.

Cyltezo is a tumor necrosis factor (TNF) blocker approved for the following indications:

• Rheumatoid arthritis: To reduce signs and symptoms, induce major clinical response, inhibit the progression of structural damage, and improve physical function in adult patients with moderately to severely active rheumatoid arthritis; can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
• Juvenile idiopathic arthritis: To reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older; can be used alone or in combination with methotrexate.
• Psoriatic arthritis: To reduce signs and symptoms, inhibit the progression of structural damage, and improve physical function in adult patients with active psoriatic arthritis; can be used alone or in combination with non-biologic DMARDs.
• Ankylosing spondylitis: To reduce signs and symptoms in adult patients with active ankylosing spondylitis.
• Crohn disease: Treatment of moderately to severely active Crohn disease in adults and pediatric patients 6 years of age and older.
• Ulcerative colitis: Treatment of moderately to severely active ulcerative colitis in adult patients.
• Plaque psoriasis: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate; should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
• Hidradenitis suppurativa: Treatment of moderate to severe hidradenitis suppurativa in adult patients.

The prefilled Cyltezo Pen 40mg/0.8mL will be available in 2-, 4- and 6-pack options on July 1, 2023. According to Boehringer Ingelheim, the pen was designed with patient-centered features to simplify the administration process.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.