FDA NewsPerspective

FDA approves Amjevita, biosimilar to Humira

The FDA has approved Amjevita, a biosimilar to Humira, according to an FDA press release.

Janet Woodcock
Janet Woodcock

“This is the fourth FDA-approved biosimilar,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions.”

Amjevita (adalimumab-atto, Amgen) is indicated for multiple inflammatory diseases in adults including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. In addition, it is indicated for polyarticular juvenile idiopathic arthritis for patients aged 4 years and older.

A biosimilar is a biological product that has been approved because it is highly similar to an already approved product and has no clinically meaningful differences in terms of safety and effectiveness.

The FDA’s approval is based on review of structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data and clinical immunogenicity data.

Like Humira (adalimumab, AbbVie), the box warning alerts health care workers that there is an increased risk for serious infections leading to hospitalization or death. In addition, lymphoma and other malignancies have been reported in children and adolescents treated with tumor necrosis factor blockers, including adalimumab products.

“[Amjevita] holds the potential to offer patients with chronic inflammatory diseases an additional treatment option,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a company press release. “This milestone exemplifies our ongoing dedication to the development of high-quality biologic medicines.” – by Will Offit

 

References:

www.fda.gov

www.amgen.com

The FDA has approved Amjevita, a biosimilar to Humira, according to an FDA press release.

Janet Woodcock
Janet Woodcock

“This is the fourth FDA-approved biosimilar,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions.”

Amjevita (adalimumab-atto, Amgen) is indicated for multiple inflammatory diseases in adults including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. In addition, it is indicated for polyarticular juvenile idiopathic arthritis for patients aged 4 years and older.

A biosimilar is a biological product that has been approved because it is highly similar to an already approved product and has no clinically meaningful differences in terms of safety and effectiveness.

The FDA’s approval is based on review of structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data and clinical immunogenicity data.

Like Humira (adalimumab, AbbVie), the box warning alerts health care workers that there is an increased risk for serious infections leading to hospitalization or death. In addition, lymphoma and other malignancies have been reported in children and adolescents treated with tumor necrosis factor blockers, including adalimumab products.

“[Amjevita] holds the potential to offer patients with chronic inflammatory diseases an additional treatment option,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a company press release. “This milestone exemplifies our ongoing dedication to the development of high-quality biologic medicines.” – by Will Offit

 

References:

www.fda.gov

www.amgen.com

    Perspective
    Leonard H. Calabrese

    Leonard H. Calabrese

    Yet another biosimilar has been approved.

    “Water, water, everywhere,

    And all the boards did shrink;

    Water, water, everywhere,

    Nor any drop to drink.” 

    Coleridge – The Rime of the Ancient Mariner

    On Sept. 23, the FDA approved Amjevita, Amgen’s biosimilar adalimumab to Humira, now making four approved agents in this space. The advisory boards have been overwhelmingly convinced with recent votes of 26 to 0.  For rheumatologists and our patients, however, it is a case of “biosimilars everywhere and none of them to give” – that is if you live in the United States.

    Currently rheumatologists and other practitioners are unable to prescribe these new agents which are in already in worldwide use.  In Finland alone, they have saved their national health system more than 50% on their biologic therapeutic tab for tumor necrosis factor inhibitors. The only people making money in the United States now are lawyers litigating patent disputes. 

    If I sound angry that is because I am. Of course, there are some sticky issues left not least of which is interchangeability. On the other hand, if there was a biosimilar approved and it was of an agent I would consider first line for my patient, then I would use it to start unhesitatingly. Stay tuned.

    • Leonard H. Calabrese, DO
    • Chief Medical Editor, Healio Rheumatology Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University RJ Fasenmyer Chair of Clinical Immunology Cleveland Clinic Cleveland @LCalabreseDO

    Disclosures: Calabrese reports he is a consultant for Genentech, Pfizer, Bristol-Myers Squibb, GlaxoSmithKline, Sanofi, Jansen and AbbVie; and is on the speakers bureau for Genentech, AbbVie and Bristol-Myers Squibb and Crescendo Bioscience.