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


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 enterthe 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.

Mylan’s shares were up 4.45% on Friday on rumours about Amazon’s plan to enter pharmacy segment. Meanwhile, shares of the company have declined 0.1% so far this year, outperforming the industry’s fall of 29.7% in that period.

Ogivri is the first approved biosimilar of Herceptin in the United States. Earlier in March, Mylan received global license to trastuzumab product from Roche allowing it to commercialize the biosimilar worldwide.

Mylan is already a leading supplier of cancer medications. The company’s supply network may help Ogivri reach patients quickly, boosting its prospects. A potential approval in Europe will provide a further boost.

In a separate press release, Mylan announced that the FDA has approved its generic version of for blood thinner, Heparin. Mylan is focused on developing generics/biosimilars of popular drugs with 16 biosimilars in its portfolio. Per the press release, Mylan currently has 211 abbreviated new drug applications under review, which represent $93.2 billion in annual brand sales.

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

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