Biosimilars: Eight Is More Than Enough For FDA

Eight pre-IND and IND applications for biosimilar products have been submitted to the Division of Therapeutic Proteins in CDER's Office of Biotechnology Products, according to division Director Amy Rosenberg.

"There has been a dramatic increase in [the division's] regulatory load, including novel regulatory paradigms such as biosimilars," Rosenberg said May 31 during the Cellular, Tissue and Gene Therapies Advisory Committee meeting. "Biosimilars are a tremendous strain on our research reviewers."

All but one of the applications were sent to the division's Laboratory of Biochemistry, though the Laboratory of Chemistry was assigned one pre-IND, she said.

"These reviews are much more intensive than other pre-IND and IND applications. These meetings are coordinated by having a special committee, the Biosimilar Review Committee, and require enormous amounts of time, not just for reviewing individual applications, but also for policy issues as well as guidance documents."

That heavy upfront review burden seems part of the reason why FDA wants the user fees for biosimilars to be paid starting at the IND stage, not just with the marketing application as they are for innovator products (Also see "Biosimilars: FDA Trying Group-Think Negotiating Strategy For User Fee" - Pink Sheet, 16 May, 2011.).

While biosimilars don't work the same as generic drugs, there are similar advantages such as "less information on the application because of what we know from the product and structural similarity, [and] similarity in other ways to marketed product," Steven Kozlowski, director of the Office of Biotechnology Products, observed.

Both Koslowski and Rosenberg said they hoped to see "biobetter" applications come in soon. "We all hope for better products than what we have, and indeed, when there’s competition, we start seeing engineered versions of prototype products with enhanced product quality attributes, novel technology products, and we have a lot of focus on immune responses to our protein products, because they can be devastating," Rosenberg said.

"This is a really important public health concern, but the science, especially the science around quality and structural analysis, becomes critical for us to do in the right way," Koslowski said.

The agency recently said that it has conducted 14 pre-IND meetings for proposed biosimilar development programs (Also see "FDA “Busy” With Biosimilars; Sponsors Already In Pre-IND Meetings" - Pink Sheet, 16 May, 2011.).

The Division of Therapeutic Proteins will only be a part of the review team responsible for biosimilar applications "when appropriate," FDA said in an email. The agency declined to disclose how many of the applications Rosenberg had mentioned had been approved or were still pending, and how many were from private sponsors, citing commercial confidentiality.

– Martin Berman-Gorvine ([email protected])