Celebrating the 4th: US Biosimilar Regulatory Recap 2022

So far in 2022, the United States has taken some big steps in increasing biosimilar access and adoption throughout the nation, including 3 FDA approvals, an investigation into pharmacy benefit managers, and progress on congressional action.

February 15: Robert Califf, MD, obtained approval from Senate to become the FDA commissioner in a 50-46 vote. Califf is a highly cited cardiologist and founder of the Duke Clinical Research Institute who has previously served as senior advisory to Verily and Google Health. He was in charge of the FDA during the last 11 months of Barack Obama’s presidency and was nominated for the position in November 2021.

February 21: Purva Rawal, PhD, senior advisor and chief strategy officer at the Center for Medicare and Medicaid Innovation (CMMI), told industry leaders at the Association for Accessible Medicines’ Access! Annual meeting that CMS is committed to implementing policies that aim to expand biosimilar utilization in order to ensure drugs are more affordable to Americans. Most of the talk focused on CMMI’s “strategy refresh” process that will help the agency implement alternative payment models.

February 28: The FDA accepted applications for interchangeability status from Alvotech and Pfizer for their respective adalimumab biosimilars referencing Humira. Pfizer’s biosimilar (Abrilada) was originally approved in November 2019. The interchangeability application for Alvotech’s biosimilar (AVT02) was submitted along with the biologics license application for approval. Alvotech said that it hopes that AVT02 will be the first high-concentration, citrate-free adalimumab biosimilar to receive an interchangeability designation.

March 3: Kashiv Biosciences and Amneal Pharmaceuticals scored their first FDA approval of the year for Releuko, a filgrastim biosimilar referencing Neupogen. The approval also marked the first biosimilar approval in 2022, Releuko is the third filgrastim biosimilar to be approved for the US market.

March 19: The HHS Office of Inspector General announced that it would conduct a study on the use and spending of biosimilars within Medicare Part B plans. The study will commence in 2023 and will show the use spending trends of biosimilars compared to their reference products covered by Part B plans. Shortly after the announcement, the FDA updated its guidance to expand clinical trial enrollment to include patients over 65 years old.

April 13: The FDA approved Amneal Pharmaceuticals’ bevacizumab biosimilar, Alymsys, representing the second biosimilar approval in 2022 and third bevacizumab biosimilar approval for the United States.

May 12: HR 7667, also known as the Biosimilar User Fee Amendments of 2022, was introduced to the House of Representatives and was referred to the Committee on Energy and Commerce, which voted unanimously to advance the measure. The bill seeks to amend the Federal Food, Drug, and Cosmetic Act to expand FDA user fee programs for prescription drugs and medical devices, including biosimilars and generics.

June 1: The FDA approved the fifth pegfilgrastim biosimilar for the US market, Amneal Pharmaceuticals and Kashiv Biosciences’ Fylnetra referencing Neulasta. The approval represented the third FDA biosimilar approval of the year.

June 9: The Federal Trade Commission (FTC) announced that it would launch an investigation into the practices of pharmacy benefit managers (PBMs), which providers and advocacy groups have been warning are interfering with biosimilar adoption and formulary decision-making. The move came after the FTC received 24,000 comments by the May 24 deadline. As part of the investigation, the agency will demand that the 6 largest PBMs submit record and answer questions regarding their business practices.

June 27: The Center for Biosimilars® Sarfaraz K. Niazi, PhD, wrote a piece detailing his efforts working with congressional leaders to introduce a bill (S 4288) that seeks to remove the requirement for animal testing in biosimilar approval applications. Niazi argued that animal testing does not provide meaningful data on the safety or efficacy of biologic drugs and can be expensive, time-consuming, and cruel to animals.