Biosimilars Guidelines Attract Attention, Criticism

As Genetic Engineering & Biotechnology News reported in mid-April, the US Food and Drug Administration's (FDA) draft biosimilar regulations attracted mostly negative comments. Now some companies are adding further commentary to the pile-and they're bringing up points of substantial friction with FDA.

Pharmaceutical manufacturer Amgen told FDA regulators that "requiring the maintenance of biosimilarity over time would inhibit manufacturing and quality improvements and unduly burden industry without benefiting patients," reports In-Pharma Technologist.

At issue to Amgen and others is a concern that once a biosimilar product is approved, FDA might mandate that its biosimilarity be maintained relative to the innovative product, reports In-Pharma.

The lack of FDA guidance on the matter is causing industry jitters, and Amgen's Paul Eisenberg, senior vice president, wrote FDA to call for a snapshot approach to biosimilarity. If applicants must continually update their products to meet the changes in the innovative product, Eisenberg argues, innovative advancements might not be made.

Others are taking an approach seemingly geared toward protecting innovative biologic products.

The Biotechnology Industry Organization (BIO), an eminent biotechnology trade association, called upon FDA to permit fewer differences even as it should demand increased amounts of equivalence testing, writes Patent Docs. [Editor's note: Patent Docs is affiliated with BIO]

"BIO advocates that the FDA expand the requirements to prove biosimilarity significantly beyond the minimum tests required in the statute, and generally recommends policies that make it more difficult to obtain Abbreviate Biologics Licensing Application (ABLA) approval," wrote Patent Docs. "BIO recognizes the need for distinguishing biologics and biosimilars from traditional small molecule generic drugs, both in terms of complexity and the quantity of clinical data required for approval."

Read more:

In-Pharma Technologist - Amgen Warns Biosimilar Draft a Threat to Production Innovation

Patent Docs - BIO Comments on FDA Biosimilars Guidance: Demand More Testing, Permit Fewer Differences

BIO - BIO Submits Comments on FDA Draft Guidances on Biosimilars

Regulatory Focus - Report: Comments on Draft Biosimilar Guidelines Mostly Trend Negative

Regulatory Focus - FDA Releases Long-Awaited Guidances on Biosimilar Price Competition and Innovation Act

Regulatory Focus - EU to Unveil New Follow-on Biologic Guidelines in Late Q1

Regulatory Focus - FDA Seeks Input on Biosimilars Application