What Might Be Impact of First Interchangeable Biosimilar?

More than 10 years after the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Affordable Care Act, the FDA finally has approved the first interchangeable biosimilar. But while many in the industry are hailing the move, at least one expert wonders whether interchangeables will hamstring use of biosimilars that do not have that designation.

On July 28, the FDA approved Viatris Inc. and Biocon Ltd. subsidiary Biocon Biologics Ltd.’s Semglee (insulin glargine-yfgn) to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. It is a biosimilar to and interchangeable with its reference product, Sanofi Aventis’ Lantus (insulin glargine), a long-acting insulin analog. The product will be available in 10 mL vials and 3 mL prefilled pens and is administered subcutaneously once daily. It also has 12 months of exclusivity under section 351(k)(6) of the Public Health Service (PHS) Act during which the FDA cannot approve another biosimilar that is interchangeable with Lantus.

The FDA also issued three fact sheets to help improve understanding of biosimilars and interchangeable biosimilars.

Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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