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  • Susan Cuozzo

Biosimilar Buzz

There has been mounting buzz about biosimilars coming to market. The Food and Drug Administration (FDA) recently approved Hadlima (adalimumab-bwwd) for all eligible indications (rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis) of the biologic product, Humira (adalimumab, AbbVie) according to a company press release by Samsung Bioepis. Most of us know someone taking Humira, and this news seems exciting, but are you just not sure what to make of it?


Many physicians (regardless of specialty) as well as most of the health care practitioner community and the public are not quite sure about biosimilars. The FDA defines a biosimilar as “a biological product highly similar to the reference product notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” To oversimplify, biologics are far more complex than small molecule drugs and the manufacturing of biologics introduces variability. Still, extensive testing is used to establish high similarity of a biosimilar to a reference product. They are compared using an analysis algorithm that covers many product attributes and their combinations with high sensitivity.


So why is the approval and availability of biosimilars important? Biosimilars provide competition in the market and expand patient access to critical medicines. S+S{i} has worked on medical education initiatives to help demystify biosimilars here in the United States. Clearly there is more work to be done to provide clarity and facilitate fully informed prescribing decisions.


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