FDA approves Mylan drug as first biosimilar to Amgen’s Neulasta

(Reuters) – Mylan NV on Monday beat a clutch of drugmakers racing to get a biosimilar version of Amgen Inc’s drug, Neulasta, to market, with U.S. health regulators approving its version of the blockbuster infection-fighting treatment.

Mylan’s shares rose 5.4 percent to $40.57 after the bell, while Amgen fell 1.8 percent to $182.02.

Neulasta, which is used to fight infections in cancer patients, brought Amgen revenue of $4.53 billion last year and accounted for nearly 21 percent of total product sales.

In 2017, the FDA declined to approve Mylan’s copycat version of the drug, Fulphila, and asked for more data related to manufacturing facilities of the company and its partner Biocon.

Biologic drugs such as Neulasta are made inside living cells, and it is impossible to make exact generic copies. As a result, regulators are approving products deemed “similar” enough as biologics, in the hope that they increase competition in the market and help reduce soaring branded drug prices.

Mylan’s Fulphila can cause serious side effects including a rupture of the spleen, acute respiratory distress syndrome, and serious allergic reactions, the FDA said

The FDA has previously rejected biosimilars to Neulasta from Novartis AG and Coherus BioSciences Inc.

Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel

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