Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2018

Here are our picks for the most significant U.S. regulatory developments related to biosimilars in 2018:

1. FDA Releases Biosimilars Action Plan

In July, FDA released the Biosimilar Action Plan (BAP), which outlines the Administration’s proposed next steps to help reduce the costs of healthcare by expediting the development of robust biosimilar competition and market penetration, while encouraging innovation and maintaining incentives for investing in future products.  FDA has recently received comments in response to the BAP.

2. FDA Takes Action in Response to REMS Abuses

In response to inquiries from generic pharmaceutical companies regarding the effect of REMS on generic product development, FDA released two guidances outlining, as Commissioner Gottlieb described, “new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access.”  FDA also published a list of RLDs and RLD sponsor companies for which FDA has received an inquiry regarding the inability of generic companies to obtain RLD samples.

3. New Law Requires FTC and DOJ Review of Biologics Patent Settlements

In October, the President signed into law the “Patient Right to Know Drug Prices Act.”  Shortly thereafter, the law was further revised by the “SUPPORT for Patients and Communities Act,” signed on October 24, 2018.  Among other things, the new law requires Reference Product Sponsors and biosimilar applicants to file patent settlement agreements with the Federal Trade Commission and the U.S. Department of Justice for review.  In this way, the law imposes the same FTC and DOJ disclosure requirements currently in place for ANDA litigation settlements.

4. FDA Issues and Withdraws Guidances on Biosimilar Product Development

2018 saw much activity on FDA guidances related to the development of biosimilar products.  Earlier this month, FDA issued four new biosimilar guidances and a proposed rule:  two guidances address how FDA will transition certain biological products currently approved as drugs under the FDCA to licensed biologics; the other two guidances answer common questions on issues such as interchangeability and post-approval manufacturing changes; and the proposed rule seeks to define the statutory term “protein” and “chemically synthesized polypeptide.”  Throughout the year, FDA released other guidances on civil money penalties relating to the ClinicalTrials.gov data bank, implementation of BsUFA II, and formal meetings with FDA concerning the development and review of biosimilar or interchangeable biological products.  FDA also withdrew guidance regarding statistical approaches to the evaluation of analytical similarity of biosimilars.

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