March 6, 2015 was a landmark day for the biosimilar manufacturers. It is the day that U.S. Food and Drug Administration (FDA) approved a biosimilar version of filgrastim, making it the first biosimilar product to enter the U.S. market.
The approval was no great surprise. An abbreviated licensure pathway for biosimilars approval in the U.S. was established in 2010 as part of the Affordable Care Act, and filgrastim offered an attractive package of attributes making it a prime candidate for FDA’s first step into this new product category. A biosimilar version of filgrastim has been on the European market for years, and the makers can provide hundreds of thousands of days of patient outcomes data, post approval, which provides FDA with deep assurances around its safety and efficacy.