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Watch out Amgen! Mylan wins FDA approval for biosimilar of Neulasta

Mylan (MYL) celebrates the Food and Drug Administration’s go-ahead signal for its first biosimilar infection-fighting treatment Neulasta manufactured by Amgen (AMGN). Mylan plans for the first launch of its biosim Fulphila in a few weeks, with an aim of offering an inexpensive treatment for cancer patients.

FDA’s decision was applauded by Vizient, the largest member-owned healthcare services company in the US, who has always supported biosimilar approvals. On the other hand, Mylan’s share rallied on June 5 during after-market hours, while Amgen’s shares traded in the red.

Mylan plans for the first launch of its biosim Fulphila in a few weeks, with an aim of offering an inexpensive treatment for cancer patients.

In the biosimilars space, Mylan and Biocon have been partners for years. This is the second biosimilar coming from this partnership and is a part of the six products that are developed by the two companies. The list includes Roche’s Herceptin, a drug that treats breast cancer. With this new partnership, both the companies are working towards generating more profit from the competitive biosimilar market.

Back in 2017, the regulators had declined to approve the Fulphila and demanded the companies submit more data related to their manufacturing units. Fulphila’s approval comes just months after it received an approval for Ogivri, a biosimilar version of Herceptin. Earlier, the FDA had even rejected biosimilar version of Neulasta from Swiss company Novartis and Coherus BioSciences (CHRS).

Biosimilars have long been perceived as a major threat to the biopharma firm Amgen that makes billions on just a few drugs. Neulasta alone generated sales of $3.93 billion last year in the US for Amgen. Biosimilars are expected to account for the largest share of the US pharma market. The number of biosimilar approvals increased significantly over the last year.

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