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Mylan/Biocon's Herceptin Biosimilar under Review in the U.S.
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Mylan N.V. and partner Biocon Ltd. announced that the FDA had accepted their Biologics License Application (BLA) for a biosimilar version of Roche Holding AG’s (RHHBY - Free Report) cancer drug, Herceptin (trastuzumab), MYL-1401O.
Shares of Mylan have outperformed the Zacks categorized Medical-Generic Drugs industry in the past one year with the stock losing 23.7% compared to the industry’s decline of 29.8%.
Coming back to the latest news, this is Mylan’s first U.S. regulatory submission under the 351(k) pathway. A Biosimilar User Fee Act (BsUFA) 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. The company noted that it will be working with the FDA over the next months for a potential approval. Meanwhile, MYL-1401O is currently under review in the EU.
Upon approval, the candidate could provide an effective treatment option for metastatic breast cancer patients at a lower cost.
Note that the reference drug, Herceptin, is approved for the treatment of certain HER2-positive breast and gastric cancers.
We remind investors that Mylan had exclusively partnered Biocon for a broad portfolio of biosimilar and insulin products. While Mylan has exclusive commercialization rights to the Herceptin biosimilar in the U.S., Canada, Japan, Australia, New Zealand, and in the EU and the European Free Trade Association countries, Biocon holds the co-exclusive commercialization rights with Mylan for the same in the rest of the world.
Note that Pfizer Inc. (PFE - Free Report) is also developing its own biosimilar version of Herceptin, which is currently in a late stage study.
Sucmapo’s earnings estimates were stable at $1.22 for 2016 but have increased from $1.30 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.
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Mylan/Biocon's Herceptin Biosimilar under Review in the U.S.
Mylan N.V. and partner Biocon Ltd. announced that the FDA had accepted their Biologics License Application (BLA) for a biosimilar version of Roche Holding AG’s (RHHBY - Free Report) cancer drug, Herceptin (trastuzumab), MYL-1401O.
Shares of Mylan have outperformed the Zacks categorized Medical-Generic Drugs industry in the past one year with the stock losing 23.7% compared to the industry’s decline of 29.8%.
Coming back to the latest news, this is Mylan’s first U.S. regulatory submission under the 351(k) pathway. A Biosimilar User Fee Act (BsUFA) 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. The company noted that it will be working with the FDA over the next months for a potential approval. Meanwhile, MYL-1401O is currently under review in the EU.
Upon approval, the candidate could provide an effective treatment option for metastatic breast cancer patients at a lower cost.
Note that the reference drug, Herceptin, is approved for the treatment of certain HER2-positive breast and gastric cancers.
We remind investors that Mylan had exclusively partnered Biocon for a broad portfolio of biosimilar and insulin products. While Mylan has exclusive commercialization rights to the Herceptin biosimilar in the U.S., Canada, Japan, Australia, New Zealand, and in the EU and the European Free Trade Association countries, Biocon holds the co-exclusive commercialization rights with Mylan for the same in the rest of the world.
Note that Pfizer Inc. (PFE - Free Report) is also developing its own biosimilar version of Herceptin, which is currently in a late stage study.
Mylan N.V. Price and Consensus
Mylan N.V. Price and Consensus | Mylan N.V. Quote
Mylan currently carries a Zacks Rank #4 (Sell).
Key Picks in the Sector
Sucampo Pharmaceuticals, Inc. is a better-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucmapo’s earnings estimates were stable at $1.22 for 2016 but have increased from $1.30 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>