Mylan Wins Big With FDA Approval

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Mylan N.V. (NASDAQ: MYL) saw its shares make a handy gain early on Tuesday after the U.S. Food and Drug Administration (FDA) announced a key approval. The agency approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim).

Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.

Also, this is the second FDA-approved biosimilar through the Mylan-Biocon collaboration, further demonstrating the companies’ leadership and commitment to expanding patient access to critical biologic medicines.

In the United States, Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients.

Heather Bresch, Mylan CEO, commented:

I couldn’t be prouder of this approval for Fulphila, the first alternative option for pegfilgrastim approved in the U.S., as it represents an important milestone for patients and further demonstrates Mylan’s continued fight to expand access to medicine. FDA’s approval of this product, as well as the agency’s continued focus on biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients. As a leading supplier of cancer medicines in the U.S, Mylan is committed to offering affordable and accessible solutions for patients with cancer at every step of their journey. Enhancing access to treatment has always been our top priority and what we’ll continue to deliver to the healthcare system in the U.S. and beyond.

Shares of Mylan closed Monday at $38.50, with a consensus analyst price target of $49.71 and a 52-week range of $29.39 to $47.82. Following the announcement, the stock was up about 5% at $40.49 in early trading indications Tuesday.