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Mylan's Proposed Biosimailar for Cancer Under Review in U.S.
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Mylan N.V. and Biocon Ltd. announced that the FDA has accepted their biologics license application for a biosimilar version of Amgen’s (AMGN - Free Report) 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 - Free Report) 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 currently carries a Zacks Rank #4 (Sell). Abetter-ranked stocks in the health care sector include Sunesis Pharmaceuticals 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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Mylan's Proposed Biosimailar for Cancer Under Review in U.S.
Mylan N.V. and Biocon Ltd. announced that the FDA has accepted their biologics license application for a biosimilar version of Amgen’s (AMGN - Free Report) 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 - Free Report) 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 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%.
Just Released – Driverless Cars: Your Roadmap to Mega-Profits Today
In this latest Special Report, Zacks’ Aggressive Growth Strategist Brian Bolan explores a full-blown technological breakthrough in the making – autonomous cars. He also spotlights 8 stocks with tremendous gain potential to feed off this phenomenon. Click to see the stocks right now >>