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Focus on Regulation

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives for innovators to invest in further research.  On July 19, FDA also published the guidance “Labeling for Biosimilar Products,” finalizing an April 2016 draft guidance that Dr. Gottlieb said aims to help biosimilar manufacturers prepare labeling submissions in a manner that would achieve FDA approval.  The BAP specifically summarizes 11 steps FDA will be taking to foster the biosimilars market, including:

  • Establishing an Office of Therapeutic Biologics and Biosimilars (OTBB);
  • Exploring the option of data sharing agreements with foreign regulators, such that U.S. drug makers could evaluate biosimilars by using European or Asian drugs as comparator products;
  • Developing an index of biosimilars’ critical quality attributes relative to their reference products;
  • Implementing new FDA review tools, such as standardized review templates, that are tailored to applications for biosimilar and interchangeable products; and
  • Adding more data about approved biologics to the Purple Book.

In a July 16 statement on HHS’s Blueprint to lower drug prices, the Federal Trade Commission (FTC) had urged FDA to finalize a January 2017 draft guidance that would facilitate approval of intgerchangeable biosimilar products, which the FTC described as more likely to permit automatic substitution; Dr. Gottlieb also prioritized action on this interchangeability guidance in the BAP.

FDA announces public hearing on BAP

The FDA announced July 25 that it will hold a public hearing on September 4 to gather input on the BAP, as well as ways FDA can facilitate the development of biosimilars and ensure they enter the market in a timely fashion.  At the hearing at FDA’s White Oak HQ, the agency will solicit input from stakeholders on nine questions addressing scientific and legal challenges to bringing biosimilars to market and measures to reduce barriers to competition once they are on the market.  The registration deadline for persons seeking to attend or present at the hearing is August 14.

In its meeting notice, FDA requested comment on the potential application of “umbrella exclusivity” to biological products pursuant to section 351(k)(7) of the Public Health Service (PHS) Act.  Noting that umbrella exclusivity has long been used in the Hatch-Waxman context for small molecule drugs,

FDA points out that this approach aims to promote biological product innovation by shielding certain biologics from biosimilar competition.  Innovators should consider remarks to FDA emphasizing the importance of protecting improvements to their original products without fear that doing so within the 12-year statutory exclusivity period would expose the biologic to biosimilar competition before the sunset of the exclusivity period.  The deadline for submitting written comments is September 21.

Dr. Gottlieb decries “anemic” biosimilars competition

In his July 18 speech at the Brookings Institution, Dr. Gottlieb emphasized the “anemic” competition in the biosimilars industry, blaming a “rigged system” whereby “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…rather than embrace biosimilar competition and lower prices.”  Dr. Gottlieb also blamed litigation for delaying market access to biosimilars.

Dr. Gottlieb said the FDA would “soon” release the details of its analysis that found timely marketing of biosimilars in the U.S. could have saved consumers more than $4.5 billion in 2017.  Only three of 11 FDA-approved biosimilars have made it to market, and FDA has approved two biosimilars this year.  The agency is making clear its prioritization of promoting the manufacture and approval of additional biosimilars.