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Will Companies Be Able to Launch ‘Authorized Biosimilars’ In The Future? Eli Lilly Wants To Know

 
• By Dean Rudge

In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to clarify whether regulatory mechanisms exist for biological product sponsors to introduce ‘second versions’ of their innovative biological products.

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Clarity on 'branded biosimilars' will increase biologic competition, Eli Lilly says. • Source: Shutterstock

The US Food and Drug Administration (FDA) is being urged to clarify the “applicable regulatory mechanisms” for companies to introduce “second versions,” or “branded biosimilars,” of their own reference products, in light of the agency’s intention to transition the regulation of certain new drug applications (NDAs), including insulins, to regulation as biologic license applications (BLAs).

Insulins specialist Eli Lilly made the request in its feedback to the agency’s draft guidance, The ‘Deemed to be a License’ Provision of the Biologics Price and Competition Innovation (BPCI) Act: Questions and

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