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Mylan (MYL) Gets FDA Approval for Biosimilar of Neulasta

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Mylan N.V MYL and partner Biocon announced that the FDA has approved Fulphila, a biosimilar of Amgen’s AMGN Neulasta.

The news comes as a significant boost for Mylan, given the potential market for Fulphilia. According to the IQVIA, Neulasta generated U.S. sales of $4.2 billion for the twelve months ending Mar 31, 2018.

The biosimilar 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.

Notably, this is the first FDA-approved biosimilar of Neulasta. The company plans to launch the biosimilar in the coming weeks.

The approval will broaden Mylan’s biosimilars portfolio. The FDA approval was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the biosimilar is highly similar to the branded drug. The data demonstrated that there were no clinically meaningful differences between the biosimilar product and Neulasta in terms of safety, purity and potency.

Both the companies had earlier won FDA approval for Ogivri, a biosimilar of Herceptin. The biosimilar is also approved for 30 additional countries. Mylan and Biocon are collaborating to develop 11 biologic and insulin products. While Mylan owns the commercialization rights for the product in the United States, Canada, Japan, Australia, New Zealand, the European Union and European Free Trade Association countries, Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world. In March 2018, Mylan and Biocon announced that their co-developed biosimilar insulin glargine Semglee has obtained approval from the European Commission (EC) following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency.

We note that Mylan has one of the widest portfolios of generics and biosimilars. The company has a portfolio of 20 bioismilar and insulin analog products.

Mylan’s stock has gained 11.5% in the last six months compared with the industry’s decline of 0.6%. Shares are trading up on the news.

Mylan’s efforts to develop its biosimilars portfolio is impressive. Mylan also has a partnership with Momenta Pharmaceuticals MNTA for the development of biosimilars.  Both the companies plan to initiate a patient clinical trial of M710 — a proposed biosimilar of Regeneron Pharmaceuticals’ REGN Eylea — in the first half of 2018. The trial will be a randomized, double-blind, active-control, multicenter study in patients with diabetic macular edema to compare the safety, efficacy and immunogenicity of M710 with the reference drug. Eylea, a vascular endothelial growth factor (VEGF) inhibitor, has been approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema, following retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema.

Although volatility in the United States markets is expected to continue in 2018, yet these new approvals should position Mylan better in the year ahead and help it combat the decline in EpiPen sales.

Zacks Rank

Mylan carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.

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