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Mylan's Proposed Biosimailar for Cancer Under Review in U.S.

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Mylan N.V.MYL and Biocon Ltd. announced that the FDA has accepted their biologics license application for a biosimilar version of Amgen's AMGN Neulasta (pegfilgrastim) - MYL-1401H. We note that this is Mylan's second U.S. regulatory submission under the 351(k) pathway. A Biosimilar User Fee Act date is scheduled for Oct 9, 2017.

Mylan's share price increased 10.1% year- to -date compared with the Zacks classified Medical-Generic Drugs industry's gain of 9.2%.

Neulasta helps reduce the chance of infection from low white blood cell count, in patients with certain types of cancer (non-myeloid), who receive anti-cancer treatment like chemotherapy that can cause fever and a low blood cell count.. A potential approval of the proposed biosimilar will add to Mylan's oncology portfolio which focuses on expanding access to more affordable treatments for multiple types of cancer.

Mylan has exclusive rights to commercialize MYL-1401H in the U.S., Canada, Japan, Australia, New Zealand and in the European Union as well as European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

In January 2017, the two companies also announced that the FDA has accepted their biologics license application for a biosimilar version of Roche Holding AG's RHHBY Herceptin, MYL-1401O. This was Mylan's first U.S. regulatory submission under the 351(k) pathway. A Biosimilar User Fee Act date is scheduled for Sep 3, 2017.

Mylan believes that it has the potential to be the first to seek approval for a biosimilar version of Herceptin in the U.S. Meanwhile, MYL-1401O is currently under review in the EU.

After the approval, the candidate could provide an effective treatment option for metastatic breast cancer patients at a lower cost.

Mylan N.V. Price

Mylan N.V. Price | Mylan N.V. Quote

Zacks Rank & Key Picks

Mylan currently carries a Zacks Rank #4 (Sell). Abetter-ranked stocks in the health care sector include Sunesis Pharmaceuticals SNSS which sports a Zacks Rank#1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here

Sunesis' loss estimates narrowed by 5.06% and 8.80% for 2016 and 2017, respectively, over the past 30 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.

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Roche Holding AG (RHHBY): Free Stock Analysis Report

Amgen Inc. (AMGN): Free Stock Analysis Report

Mylan N.V. (MYL): Free Stock Analysis Report

Sunesis Pharmaceuticals, Inc. (SNSS): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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