Momenta Pharmaceuticals, Inc. (MNTA)

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Mylan Up on FDA Approval & Amazon's Rumored Pharmacy Interest

Zacks December 4, 2017
Mylan N.V. MYL and its India-based partner Biocon announced that the FDA has approved their biosimilar version of Roche’s RHHBY Herceptin (trastuzumab). The biosimilar will be available under the tradename of Ogivri and will include all indications of Herceptin in its label including HER-2 positive breast cancer and metastatic stomach cancer.

Mylan is also seeking approval for Herceptin’s biosimilar in Europe. The company announced the acceptance of Marketing Authorization Application (“MAA”) for the biosimilar on Friday by the European Medicines Agency (“EMA”). Another MAA is looking to get approval for a biosimilar to Amgen Inc.’s AMGN neutropenia drug, Neulasta. However, the FDA has issued a complete response letter to the biologics license application seeking approval for a biosimilar version of Neulasta in the United States.

Meanwhile, Amazon is exploring its options to enter the pharmaceutical segment, per a report by CNBC. Amazon may first focus on distributing generics. It is reportedly in preliminary talks with generic makers like Mylan and Sandoz, Novartis’ NVS generic arm.

https://finance.yahoo.com/news/mylan-fda-approval-amazon-apos-144602672.html