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Speaker: Biosimilars Offer Opportunity for Increased Patient Access
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NEW YORK — Biosimilars are highly similar to their respective reference products and are currently priced about 15% less, according to a presenter here at the Interdisciplinary Autoimmune Summit.
“With many biopharmaceuticals going off-patent in the near future, opportunity exists to expand patient access through availability of biosimilars,” Jonathan Kay, MD, said.
In his presentation, Kay described whether biosimilar effectiveness would match that of the originally licensed biologic and whether biosimilar availability will reduce the high costs of biologics overall.
In the clinical trial design, a biosimilar must show equivalence within a prespecified margin, which is based on historical placebo-controlled trial data; whereas, a non-inferiority design is typically not adequate to assess biosimilarity, he said. Researchers also assessed immunogenicity, where a greater immunogenicity would question biosimilarity and a lower immunogenicity would not preclude biosimilarity.
Kay said a competitive marketplace with biosimilars continuing to emerge will help drive down the cost of biosimilars overall, making the medication more affordable. In addition, insurance carriers and pharmacy benefits managers will likely incentivize the switching between the reference biologic and biosimilar and between two biosimilars.
Kay said the interchangeability designation — which will allow for a switch between the reference biologic and the biosimilar without prescriber intervention — has not been granted yet.
“Interchangeability is something that makes patients nervous,” Kay said. “But as of yet, there are no interchangeable biosimilars.” – by Will Offit
Reference:
Kay J. Examining biosimilars within the IMID treatment landscape. Presented at: Interdisciplinary Autoimmune Summit; March 24-26, 2017; New York City.
Disclosure: Kay reports he receives research grants (payable to the University of Massachusetts Medical School) from AbbVie, Pfizer, Genentech, Roche Laboratories and UCB; and is a consultant for Amgen, AbbVie, AstraZeneca, Boehringer Ingelheim GmbH, Bristol-Myers Squibb, Epirus Biopharmaceuticals, Genentech, GlaxoSmithKline, Hospira, Janssen Biotech, Merck Sharp & Dohme, Pfizer, Samsung Bioepis, Sandoz, Roche Laboratories and UCB.