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.

Amjevita (adalimumab-atto), a citrate-free biosimilar to Humira^® (adalimumab), is now available in the US.

Amjevita, a tumor necrosis factor (TNF) blocker, is 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 (PsO): treating adult patients with moderate to severe chronic PsO who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

The Food and Drug Administration (FDA) approved Amjevita in September 2016 based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents. Amjevita is not interchangeable with Humira. 

Amjevita 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. 

References

1. Amjevita (adalimumab-atto), first biosimilar to Humira^®, now available in the United States. News release. Amgen. Accessed January 31, 2023. https://www.prnewswire.com/news-releases/amjevita-adalimumab-atto-first-biosimilar-to-humira-now-available-in-the-united-states-301734177.html.
2. Amjevita. Package insert. Amgen; 2022. Accessed January 31, 2022. https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Amjevita/amjevita_pi_hcp_english.pdf.

The Food and Drug Administration (FDA) will likely not complete its review of the Biologics License Application (BLA) for bimekizumab for the treatment of moderate to severe plaque psoriasis until the third quarter of 2023, according to UCB.

Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F. The application is supported by data from the phase 3 BE VIVID (ClinicalTrials.gov Identifier: NCT03370133), BE READY (ClinicalTrials.gov Identifier: NCT03410992), and BE SURE (ClinicalTrials.gov Identifier: NCT03412747) studies. 

Results from these studies showed that patients treated with bimekizumab achieved superior skin clearance at week 16 when compared with those who received placebo or adalimumab. Clinical responses were maintained in all studies for up to 1 year.

In May 2022, the FDA had issued a Complete Response Letter to UCB indicating that certain inspection observations needed to be resolved prior to approval. As part of the review process, the FDA had planned on inspecting the European manufacturing facilities for bimekizumab. A resubmitted BLA was subsequently accepted by the Agency in December 2022; at that time, the Company reported that a decision was expected by the second quarter of 2023.

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.

HealthDay News — For patients with moderately to severely active psoriatic arthritis, the tyrosine kinase 2/Janus kinase 1 inhibitor brepocitinib is effective for reducing symptoms, according to a study published online May 17 in Arthritis & Rheumatology.

Philip Mease, MD, from the University of Washington in Seattle, and colleagues conducted a placebo-controlled trial involving participants with moderately to severely active psoriatic arthritis. Two hundred eighteen participants were randomly assigned to brepocitinib 10mg once daily (QD), 30mg QD, 60mg QD, or placebo, advancing to brepocitinib 30 or 60mg QD at week 16.

The researchers found that brepocitinib 30 and 60mg QD groups had significantly greater American College of Rheumatology (ACR)20 response rates at week 16 vs placebo (66.7 and 74.6%, respectively, vs 43.3%) and had significantly higher ACR50/70, 75% and 90% improvement in Psoriasis Area and Severity Index, and Minimal Disease Activity response rates. Through week 52, response rates were maintained or improved. Adverse events were mostly mild/moderate; in 12 participants, serious adverse events occurred, including infections in six participants in the brepocitinib 30- and 60mg QD groups. There were no major adverse cardiovascular events or deaths reported.

“These data demonstrate striking efficacy and confirm the relevance of multiple signaling pathways dependent on the kinases targeted by brepocitinib in psoriatic arthritis,” Mease said in a statement. “The safety is also reassuring for brepocitinib in this study.”

Several authors disclosed financial ties to pharmaceutical companies, including Pfizer, which manufactures brepocitinib and funded the study.

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