FDA Issues Biosimilar Action Plan

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has unveiled the agency’s Biosimilars Action Plan, which is part of the agency’s efforts to increase drug competition to address drug pricing. The FDA will hold a public meeting on the plan in September.

 “At the FDA, we’re focused on advancing policies that make the process for developing biosimilars more efficient,” Gottlieb said in a speech delivered at the Brookings Institution on July 18, 2018. “To achieve these goals, I’m pleased to announce today that we’re releasing our Biosimilars Action Plan. This plan is an important piece of the Administration’s bold Blueprint to Lower Drug Prices and demonstrates the progress being made against the deliverables the President laid out.”

Gottlieb explained that a path to competition for biologics from biosimilars is key for reducing costs and facilitating more innovation. He cited that although less than 2% of Americans use biologics, they represent 40% of total spending on prescription drugs. He also noted limited biosimilars in the US market. Of the 11 FDA-approved biosimilars, only three are marketed in the US, according to information from the FDA.

“Competition is, for the most part, anemic,” Gottlieb said in his comments. “It’s anemic because consolidation across the supply chain has made it more attractive for manufacturers, Pharmacy Benefit Managers, Group Purchasing Organizations, and distributors 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 and lower prices. It’s anemic because litigation has delayed market access for biosimilar products that are, or shortly will be, available in markets outside the US several years before they’ll be available to patients here. These delays can come with enormous costs for patients and payors.”

Gottlieb provided the results of an FDA analysis of biosimilar competition across all Organisation for Economic Co-operation and Development (OECD) markets that examined the impact if all the biosimilars that the FDA approved in the US were successfully marketed here in a timely fashion. Based on these assumptions, the analysis showed that if US consumers had the opportunity to purchase successfully marketed, FDA-approved biosimilar prescription drugs, they could have saved more than $4.5 billion in 2017. The FDA says it will release the full details on this analysis soon.

“Our Biosimilars Action Plan applies many of the lessons learned from our experience with generic drugs to accelerate biosimilar competition with four key strategies,” Gottlieb said in the July statement. “First, improving the efficiency of the biosimilar and interchangeable product development and approval process. Second, maximizing scientific and regulatory clarity for the biosimilar product development community. Third, developing effective communications to improve understanding of biosimilars among patients, providers and payors. And fourth, supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products.”

As part of its biosimilar innovation efforts, the FDA is seeking to strengthen its partnerships with regulatory authorities in Europe, Japan and Canada, which the agency says can enable greater efficiency in developing safe and effective biosimilars. The agency says it is taking new steps to make the biosimilar development process more efficient. The FDA will also be updating the Purple Book, which lists biological products, and evaluate how it can incorporate additional information to give product developers more transparency.

Additionally, to meet its goals, the FDA issued its final guidance on biosimilar labeling to make sure that biosimilar products have labeling that allows health care practitioners to make informed prescribing decisions for their patients. The FDA is also developing and implementing new FDA review tools, such as standardized review templates tailored for biosimilars, as well as an index of biosimilars’ critical quality attributes relative to their reference products. The FDA also says it will coordinate with the Federal Trade Commission to address anti-competitive behavior.

The FDA will hold a public meeting on the Biosimilar Action Plan to gain stakeholder input on September 4, 2018.

Source: FDA (Speech by FDA Commissioner)  and Biosmilar Action Plan Public Meeting Notice

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