FDA panel backs first biosimilar in US, recommending approval of Novartis' version of Amgen's Neupogen

An FDA advisory panel on Wednesday voted unanimously in favour of approval of Novartis' biosimilar version of Amgen's Neupogen (filgrastim), for all five conditions for which the latter product is currently marketed. In documents released ahead of the panel vote, FDA staff commented that Novartis' product "meets the requirement for a demonstration of 'no clinically meaningful differences' between the proposed product and the reference product in terms of safety, purity, and potency."

Novartis said that its application was supported by data from five randomised trials and multiple studies in healthy volunteers to evaluate the pharmacokinetic and pharmacodynamic equivalence of the biosimilar product and Neupogen. In Phase III data disclosed in December, Novartis indicated that its biosimilar product exhibited similarity to Neupogen in the PIONEER trial.

Clearance of the therapy in the US, which Novartis currently markets in more than 40 countries under the name Zario, would mark the first approval of a biosimilar product by the FDA. The company plans to sell the drug in the US under the brand Zarxio.

Commenting on the news, Sanford C. Bernstein analyst Ronny Gal stated "this is kind of like cutting the ribbon to open a major new road," adding "it is literally a new concept in medicine." The analyst added "the need to bring low-cost competition into biologic drugs is critical in making American health care more affordable."

In August, Celltrion submitted a biosimilar version of Johnson & Johnson's arthritis drug Remicade (infliximab) for FDA clearance, while Apotex announced last month that its submission for approval of a biosimilar version of Amgen's Neulasta (pegfilgrastim) was accepted by the agency. Express Scripts estimated that $250 billion could be saved over the next decade if 11 biosimilars in development are approved.

Neupogen generated an estimated $1.2 billion in sales last year. For related analysis, read ViewPoints: A positive start for biosimilar developers in 2015 but FDA documents highlight challenges ahead. For additional information on the biosimilar market, see Biosimilar Index: Tracking the Biosimilar Development Landscape.

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