FDA Publishes Draft Rules on Biosimilars – Legal Roundup

On February 9, The Food and Drug Administration released its draft guidelines for drug makers on the abbreviated approval pathway for biosimilars, a move that could open the door to cheaper generic versions of branded biotech drugs. For your reference, here’s a roundup of legal commentary on the proposed rules:

FDA Publishes Draft Guidelines for Biosimilar Product Development (McDonnell Boehnen Hulbert & Berghoff LLP)

“The U.S. Food and Drug Administration published its long-awaited draft guidance on the development of biosimilar products today, taking a significant step toward the utilization of § 351(k) of the Public Health Service Act. Section 351(k) creates a biologics pathway that is reminiscent of the pathway set forth by the Hatch-Waxman Act for small molecule drugs.” Read more»

FDA Issues Guidance on Biosimilars (Fox Rothschild)

“The guidance documents outline some of the scientific and quality issues with developing biosimilars, as well as industry questions about the implementation of the Biologics Price Competition and Innovation Act, part of the Patient Protection and Affordable Care Act… The FDA said in the guidance documents that it expects biosimilars to be ‘highly similar’ to the reference product, which is the original biological product that received approval.” Read more»

FDA’s Draft Guidance on Scientific Considerations in Demonstrating Biosimilarity (Foley Hoag LLP)

Citing the complexity and structural variance of proteins, including differences in primary amino acid sequence, side chain modifications, glycosylation, and protein folding, FDA rightly acknowledges that ‘even minor structural differences (including certain changes in glycosylation patterns) can significantly affect a protein’s safety, purity, and/or potency.’ Although the draft guidance is not as explicit regarding the potential impact of small differences in manufacturing processes or materials, it does concede that ‘different manufacturing processes may alter a protein product in a way that could affect the safety or effectiveness of the product.’ Read more»

FDA’s Draft Guidance on Biosimilar Product Development and Intellectual Property Issues (Patton Boggs LLP)

“The abbreviated procedures require a showing of high similarity or interchangeability with an FDA-licensed biological product (reference product). These biological products are derived generally from human and/or animal materials including, among others, vaccines, proteins, tissues, blood and components thereof. While these guidelines may help a Sponsor position their biological product for approval, the Sponsor is still subject to litigation regarding relevant patents if procedures are not followed and precautions are not taken.” Read more»

FDA Issues Three Draft Guidances for Biosimilars (Morgan Lewis)

“The first draft guidance, Biosimilars Q&A, provides an overview of FDA’s current interpretation of some of the statutory requirements created by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The Biosimilars Q&A is also intended to respond generally to comments submitted to the public docket and raised during meetings with stakeholders on the biosimilar pathway.” Read more»

FDA Issues Draft Guidance Documents to Implement the Biologics Price Competition and Innovation Act of 2009 (Duane Morris LLP)

“The Scientific and Quality Considerations draft guidance details (1) the FDA’s proposal to use a risk-based, totality-of-the-evidence approach to evaluate all of the data and information provided by a sponsor in reviewing applications for biosimilar products; (2) the FDA’s recommendation that sponsors use a stepwise approach to demonstrating biosimilarity; and (3) general scientific principles in conducting comparative analyses.” Read more»

FDA Releases Long-Awaited Draft Guidances on Biosimilar Product Development (Foley Hoag LLP)

“The issuance of these three draft guidance documents is an important step in establishing a regulatory process for bringing biosimilar products to market under the framework established by the BPCI Act. To further this effort, FDA is seeking public comment on the draft guidances… Stakeholders should carefully review the draft guidances and provide comments to the Agency to make their views and concerns about the biosimilar product development process known and begin a productive dialogue.” Read more»

FDA Issues Draft Guidance Documents for Biosimilars (Morrison & Foerster LLP)

“Companies looking to enter the follow-on biologics market might be disappointed by the lack of a categorical approach by FDA, and uncertainties surrounding the totality-of-the-evidence approach that FDA proposes to use to review applications for biosimilar products. The guidance documents do not address issues such as interchangeability standards, patent litigation procedures, and exclusivity standards for reference products, and do not provide clear guidance for any particular biologic products.” Read more»

FDA Issues Draft Guidelines for Biosimilars (Patterson Belknap Webb & Tyler LLP)

“Similar to the approach adopted in Europe for biosimilar approval, the draft guidelines envision a highly product-specific process in which an applicant’s early and frequent consultation with the FDA throughout the approval process will play an integral role in the application’s success. At the outset, FDA consultation will determine the appropriate analytical testing to be performed in light of the biologic’s physiochemical properties, biological activity, and manufacturing characteristics.” Read more»

More on FDA Draft Guidelines for “Follow-on” Biologic Drug Approval Pathway (McDonnell Boehnen Hulbert & Berghoff LLP)

At first blush the draft guidances are a little disappointing to anyone looking for clear guidelines for biosimilar applications. While it is perhaps the case that the ‘correct ’ path to biosimilar licensure will only be developed by working through the issues as they arise, in the main the guidances merely recite well-known concepts (that therapeutic proteins are more chemically complex than small molecule drugs, for example).” Read more»


Related Commentary

A Comparison of US and EU Biosimilars Regimes (Fenwick & West LLP) 

• FDA Sends Prescription Drug User Fee Act V to Congress for Reauthorization (Duane Morris LLP) 


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