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# Draft Biosimilar Q&As Praised
- URL: https://www.fdaweb.com/draft-biosimilar-q-as-praised/
- Published: 2019-02-12T12:00:00.000Z
- Updated: 2026-09-15T01:03:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143357

Allergan says it “applauds FDA’s efforts to articulate thoughtful and science-driven guidelines” relating to development of biosimilar products. In a 2/11 comment [letter](https://www.regulations.gov/document?D=FDA-2011-D-0611-0076&ref=fdaweb.com) on an FDA revised draft Q&As on biosimilar development and the Biologics Price Competition and Innovation Act, the company says the agency’s 4/2015 guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” provides an instructive framework for analyzing the draft questions and answers. The company says the agency should use the draft Q&As to enhance stakeholder understanding of the tiered approach included in the Scientific Considerations guidance and not dilute it.

“Consistent with the agency’s efforts to minimize confusion and the risk of medication error among the botulinum toxin products approved under Section 351(a),” Allergan concludes, “we strongly encourage the agency to require a product sponsor seeking a determination that such product is biosimilar to a reference product to demonstrate, as part of the tiered structural and functional approach outlined in the 2015 Scientific Considerations guidance, that the specific activity of the biosimilar and the reference product and the method for determining such units of specific activity must be the same. Allergan further respectfully submits that the requirement of sameness is particularly critical for complex heteromeric biologic products such as botulinum toxins.”

Novartis and its Sandoz unit submitted specific line-by-line [comments](https://www.regulations.gov/document?D=FDA-2011-D-0611-0075&ref=fdaweb.com) on the draft Q&As.