FDA releases action plan to speed up market entry for biosimilars

The FDA unveiled plans Wednesday designed to facilitate the development, approval and market entry of biosimilars in the US. The Biosimilars Action Plan (BAP) "is aimed at promoting competition and affordability across the market for biologics and biosimilar products," commented FDA Commissioner Scott Gottlieb. "We're not going to play regulatory Whac-A-Mole with companies trying to unfairly delay or derail the entry of biosimilar competitors. We're not going to wait a decade or more for robust biosimilar competition to emerge," he said. 

Gottlieb noted that even though the agency has approved 11 biosimilars through 2018, beginning with Novartis' Zarxio (filgrastim-sndz) in 2015, only three of the products have so far reached the market. The agency previously estimated that US healthcare costs could have been reduced by $4.5 billion last year if all nine of the biosimilars approved through 2017 had been available. The agency approved two biosimilars this year, including Pfizer's Retacrit (epoetin alfa-epbx), and Mylan and Biocon's Fulphila (pegfilgrastim-jmdb).

"So far, the real savings [have] been just a fraction of even the most conservative initial estimates," Gottlieb remarked, and "you don't have to look far to understand why…Competition is, for the most part, anaemic." He blamed "consolidation across the supply chain" for encouraging various players, including manufacturers and pharmacy benefit managers, "to split monopoly profits through lucrative volume-based rebates on reference biologics, or on bundles of biologics and other products, rather than embrace biosimilar competition." He also said litigation has delayed access to biosimilars for several years among patients in the US, while the products "are, or shortly will be, available" in markets outside the country.

The Commissioner explained that the BAP will use the agency's experience with generic drugs to promote biosimilar competition through several key strategies. Specifically, the agency will seek to improve the efficiency of the biosimilar and interchangeable product development and approval process, as well as "[maximise] scientific and regulatory clarity" for companies developing biosimilars. Further, it intends to bolster competition by"reducing gaming of FDA requirements" and other tactics aimed at unfairly stalling competition to follow-on products, while also better communicating with patients, providers and payors to improve understanding of biosimilars.

Gottlieb indicated that under the initiative, the FDA wants to strengthen its relationships with regulators in Europe, Japan and Canada. He noted that the FDA is currently assessing whether data sharing agreements would provide greater insights into the real-world efficacy and safety of biosimilars, as well as potentially facilitate the increased use of non-US-licensed comparator products in certain studies in order to support regulatory approval. 

FirstWord reports in this area - Biosimilar Index: A comprehensive drug intelligence service that provides a robust, dynamically updated and highly-detailed insight into the status of leading biosimilar and NCB assets in development worldwide. Learn more. 

Separately on Wednesday, the FDA issued its final guidance on biosimilar labelling, intended to assist companies in developing labeling for submission in proposed biosimilar product applications. Gottlieb noted that the agency will also update guidance to provide greater clarity "on how biosimilar manufacturers can carve out indications from their labels where a branded drugmaker might still maintain some [intellectual property]."

Last month, the FDA withdrew draft guidance regarding statistical approaches to examining biosimilarity to further consider the scientific and regulatory issues involved. Earlier this year, Gottlieb announced steps to further encourage competition in the generic drug sector as part of the FDA's continued implementation of the Drug Competition Action Plan.

For related analysis, read ViewPoints: FDA's biosimilar plan may need a boost from the private sector.

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