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# Support for Biosimilar Product Class Guidances
- URL: https://www.fdaweb.com/support-for-biosimilar-product-class-guidances/
- Published: 2024-10-24T12:00:00.000Z
- Updated: 2026-09-14T14:45:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158046

Responding to an FDA request for information on biosimilar product development guidances, Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the agency issuing cross-cutting guidances for a class of biosimilar products rather than product-specific guidances (PSGs). The PhRMA comment [letter](https://www.regulations.gov/comment/FDA-2024-N-3228-0010?ref=fdaweb.com) says the trade group is concerned that PSGs would either be too restrictive or insufficiently flexible to keep up with the rapidly evolving science or, if drafted flexibly, would be too general to help sponsors. “Issuing guidance applicable to classes of biosimilars also promotes judicious use of limited FDA resources,” PhRMA adds.

The association also urges FDA to use its limited resources to issue class-specific guidance for product classes in which there are no licensed biosimilar products, including products with novel mechanisms of action and products that are otherwise more complex. “The greatest value proposition would be for FDA to issue guidance on newer, more innovative biosimilar product classes,” PhRMA says…. “Biosimilar products with different mechanisms of action and product complexity are increasingly under consideration. Sponsors need guidance on how best to accelerate development of such products.”

The United States Pharmacopeia (USP) [says](https://www.regulations.gov/comment/FDA-2024-N-3228-0011?ref=fdaweb.com) it too recommends that FDA concentrate on product class-specific guidances (PCSGs). It says such documents provide a broader framework applicable to multiple products with similar critical quality attributes, streamlining product development processes across various biosimilars. And USP also calls for the agency to focus on guidances for biological products without approved biosimilars. “These new guidance documents can be highly valuable in stimulating innovation and competition in underserved areas,” it says.

USP says it is prepared to work closely with FDA to align USP’s standards development efforts with the agency’s chosen guidance approach, “ensuring that manufacturers have access to the most relevant and up-to-date tools for business development.”