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FDA Updates Regulatory Pathway for Biosimilars

March 26, 2020

The US Food and Drug Administration (FDA) is transitioning to a new regulatory pathway for certain biologic drugs.

This new process will open a pathway for products at are proposed as a biosimilar to, or interchangeable with, the originator products.

A prior FDA study showed that after one generic product became available on the market, prices drop 31% to 39% compared with before the generic was available. Similarly, biosimilars marketed in the US often launch with initial list prices that are 15% to 35% lower than comparative list prices of reference products.

“Today is a milestone for the future of insulin and other important treatments – potentially a new era of proposed biosimilar and interchangeable insulin products,” stated Amy Abernethy, MD, PhD, principal deputy commissioner, and Janet Woodcock, MD, director of the center for drug evaluation and research, both of the FDA, in a press release (March 23, 2020). “We expect this regulatory transition to enable a vibrant competitive market for transitioning products, ultimately empowering patients by increasing choices and potentially lowering prices of safe, effective, high-quality medications.”

While the competition of insulin stands to gain from this new regulatory pathway, manufacturers will now be able to seek FDA approval and bring biosimilar and interchangeable versions of other products to market as well – which will further facilitate competition.

The FDA has partnered with the Federal Trade Commission to improve biosimilar approvals. This partnership is set to address false statements and promotional communications by biologic product manufacturers, deter anti-competitive business practices, and encourage a competitive marketplace for biosimilar products.

“We will also continue to work closely with those interested in producing biosimilar and interchangeable products to support efficiency in development, review, and approval of these medicines,” Drs Abernethy and Woodcock said in the press release.—Zachary Bessette

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