Biosimilars Forum Applauds FDA Decision to Reevaluate Draft Guidance
WASHINGTON, D.C., June 21, 2018 – The Biosimilars Forum applauds the Food and Drug Administration for its decision to withdraw proposed guidance on the analytical studies needed to demonstrate a biosimilar is highly similar to its reference product. The Forum had previously raised concerns that the guidance could have a negative effect on biosimilar development, and encouraged flexibility – a principle cited in the FDA’s announcement.
“The Biosimilars Forum has encouraged the FDA to build flexibility into its recommendations around biosimilars, and we are pleased that the Agency plans to reevaluate its guidance,” said Juliana M. Reed, President of the Biosimilars Forum. “We look forward to continuing to partner with the FDA to help support development of new biosimilars while ensuring the quality, safety and efficacy of these important medicines.”
About the Biosimilars Forum
The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.
Anthony Hogrebe, Marathon Strategies