Industry rejects FDA’s proposal for biosimilar product-specific guidance

Biosimilars developers have strongly rejected the US Food and Drug Administration’s (FDA) proposal to develop product-specific or class-based guidance and are urging the agency to instead put its efforts toward updating its cornerstone guidance documents for the sector.

The agency published a notice requesting comments on proposals for new biosimilars product development guidance in late July asking stakeholders to comment on the following two questions:

Which would be more useful for accelerating biosimilar development: guidance documents that focus on a particular product (product-specific guidance), or guidance documents that are cross-cutting for a class of biosimilar products (product class-specific guidance) such as monoclonal antibodies?
Should FDA focus on development of guidance documents for biological products (or classes of biological products) for which there are no approved biosimilars? Or would it be useful for FDA to continue to develop guidance on biosimilar development programs even after one or more biosimilar products have been approved for that biological product or class of biological products?

In its comments, Swiss generics and biosimilars company Sandoz noted that FDA’s resources are not infinite and that development of product specific guidance (PSGs) is “arduous.”

“Rather, biosimilar development would be better accelerated by implementing further improvements to the [biosimilars development program], especially with respect to providing earlier, more comprehensive feedback, and prioritizing foundational guidances and streamlining biosimilar development,” Sandoz wrote.

A big ‘No’ vote

The FDA published the solicitation for comments as part of its requirements under the Biosimilar User Fee Amendments of 2022 (BsUFA III). (RELATED: BsUFA III commitment letter details FDA, industry goals for biosimilars program, Regulatory Focus 21 September 2021).

The agency explained that it has been planning to release guidance across many products and product classes from 2023-2027, in contrast with the Generic Drug User Fee Amendments (GDUFA) program, which includes general and product-specific guidance, FDA explained.

The Biosimilars Forum, which represents US biosimilars developers, and the Biosimilars Council, a division of the Association for Accessible Medicines, answered strongly in the negative to both of FDA’s broad questions on development of biosimilars guidance.

“Product specific guidances would slow the development of biosimilars and would be an inappropriate use of BsUFA funds,” wrote the Biosimilars Forum, whose members include Sandoz, Teva and Pfizer, among other companies.

Given the fast pace of development of technologies and testing methods involved in the development of biosimilars, guidance documents would quickly become outdated.

“PSGs – which would become quickly outdated, slow biosimilar development, and hinder continuous improvements in biosimilar development, and hinder continuous improvements in biosimilar development – would be an unjustified step backwards,” the Biosimilars Forum wrote.

“PSGs for generic drugs are often published mid-review or at the end of a review, limiting the value they add to product development and in many cases inhibiting development when sponsors are required to conduct new studies or negotiate with FDA about what requirements apply,” the organization went on to say. “We are concerned that a similar dynamic will occur with biosimilar PSGs, especially considering the fast-evolving science.”

Weighing in with similar comments, the Biosimilars Council noted the toll of biosimilar development, which typically takes 6-9 years and costs $100-$300 million.

“Testing and methods that were cutting edge during PSG development may be quickly replaced by new innovations and PSG changes will inevitably be needed during this timeframe,” the Biosimilars Council wrote.

FDA will have a hard time keeping up with developments and guidance documents will get out of date, which could have the effect of slowing drug development, the organization added.

The Biosimilars Forum and the Biosimilars Council have similar concerns when it comes to development of product class-specific guidance documents.

“Overall, FDA’s guidance and policy development activities should not be focused on specific products or even product classes,” the Biosimilars Forum wrote. “Instead, FDA should be developing and updating guidance that supports a policy environment favorable to biosimilars development more broadly.”

Biosimilars developers are asking the FDA to use its funds to streamline the development of biosimilars in other ways, for example by finalizing “foundational guidances” for biosimilars and clarifying regulatory processes for development. The Biosimilars Council noted that the agency’s guidance Scientific Considerations in Demonstrating Biosimilarity to a Reference Product was released in 2015 and is in need of an update, as 61 biosimilars are now approved by FDA.

“The way forward is to continue our current work; developing PSGs would be a move backwards,” the Biosimilars Forum advised.

However, not all were purely critical of the agency’s suggestions. The Pharmaceutical Research and Manufacturers of America (PhRMA) said that while it believes product-specific guidance for biosimilars would not be beneficial, it would like to see FDA issue “guidance documents that are cross-cutting for a class of biosimilar products, so that they can be applied to multiple biosimilar products with shared features, such as a mechanism of action.” The group also wrote that FDA should focus its efforts on developing class-specific guidance on product classes in which there are no licensed biosimilars.

“The greatest value proposition would be for FDA to issue guidance on newer, more innovative biosimilar product classes. In addition to promoting judicious use of FDA’s limited resources, focusing on newer, more innovative biosimilar product classes may encourage the development of a broader scope of biosimilar products,” PhRMA wrote.

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Industry rejects FDA’s proposal for biosimilar product-specific guidance

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