We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Mylan's Biosimilar of Neulasta Gets Positive CHMP Opinion
Read MoreHide Full Article
Mylan N.V. and partner Biocon Ltd. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Fulphila, a biosimilar to Amgen's (AMGN - Free Report) blockbuster drug, Neulasta (pegfilgrastim).
The CHMP positive opinion is based on a positive review of data from various studies demonstrating biosimilarity. A phase I program in healthy volunteers and a phase III study conducted in breast cancer patients receiving adjuvant and neoadjuvant chemotherapy showed no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity compared to Neulasta.
We note that the positive opinion from the CHMP will now be considered by the European Commission, which, however, isn’t bound to it. A decision is expected by November 2018.
Neulasta boosts white cells and helps reduce the risk of infection during strong chemotherapy.
A tentative approval of Neulasta will further boost Mylan’s biosimilar portfolio. The drug recorded sales of more than $450 million in Europe for the 12 months ending Jun 30, 2018.
Earlier in 2018, the FDA approved Fulphila. Per the company, this is the first FDA-approved biosimilar of Neulasta in the United States.
Mylan is making efforts to strengthen its biosimilar portfolio. A partnership with Biocon, and collaborations with Momenta Pharmaceuticals, Inc. and Mabion have helped Mylan develop a portfolio of 20 biosimilar/insulin analog generic products.
The Biocon partnership includes six biosimilar programs such as biosimilar versions of Herceptin, Neulasta, Humira, Avastin, Enbrel and Neupogen, and three insulin analogs like Lantus, Humalog and NovoLog. The company received a major boost with the FDA approval of Ogiviri, the biosimilar version of Herceptin.
Meanwhile, Sandoz, the generic arm of Novartis (NVS - Free Report) , also received a positive CHMP opinion for the biosimilar of Neulasta.
Mylan’s shares have declined 7.8% in the year so far against the industry’s growth of 7.9%.
The company has been going through a rough patch. Mylan stated that it is evaluating strategic alternatives as the generic business in North America continues to experience pricing and competitive pressure.
Concurrent with its second-quarter results, the company also lowered its outlook as a result of the change in expected complex product launch, utilization assumptions, resizing of product opportunities in the United States, and the negative impact on operations of the restructuring and remediation program in Morgantown.
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Mylan's Biosimilar of Neulasta Gets Positive CHMP Opinion
Mylan N.V. and partner Biocon Ltd. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Fulphila, a biosimilar to Amgen's (AMGN - Free Report) blockbuster drug, Neulasta (pegfilgrastim).
The CHMP positive opinion is based on a positive review of data from various studies demonstrating biosimilarity. A phase I program in healthy volunteers and a phase III study conducted in breast cancer patients receiving adjuvant and neoadjuvant chemotherapy showed no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity compared to Neulasta.
We note that the positive opinion from the CHMP will now be considered by the European Commission, which, however, isn’t bound to it. A decision is expected by November 2018.
Neulasta boosts white cells and helps reduce the risk of infection during strong chemotherapy.
A tentative approval of Neulasta will further boost Mylan’s biosimilar portfolio. The drug recorded sales of more than $450 million in Europe for the 12 months ending Jun 30, 2018.
Earlier in 2018, the FDA approved Fulphila. Per the company, this is the first FDA-approved biosimilar of Neulasta in the United States.
Mylan is making efforts to strengthen its biosimilar portfolio. A partnership with Biocon, and collaborations with Momenta Pharmaceuticals, Inc. and Mabion have helped Mylan develop a portfolio of 20 biosimilar/insulin analog generic products.
The Biocon partnership includes six biosimilar programs such as biosimilar versions of Herceptin, Neulasta, Humira, Avastin, Enbrel and Neupogen, and three insulin analogs like Lantus, Humalog and NovoLog. The company received a major boost with the FDA approval of Ogiviri, the biosimilar version of Herceptin.
Meanwhile, Sandoz, the generic arm of Novartis (NVS - Free Report) , also received a positive CHMP opinion for the biosimilar of Neulasta.
Mylan’s shares have declined 7.8% in the year so far against the industry’s growth of 7.9%.
The company has been going through a rough patch. Mylan stated that it is evaluating strategic alternatives as the generic business in North America continues to experience pricing and competitive pressure.
Concurrent with its second-quarter results, the company also lowered its outlook as a result of the change in expected complex product launch, utilization assumptions, resizing of product opportunities in the United States, and the negative impact on operations of the restructuring and remediation program in Morgantown.
Zacks Rank
Mylan currently carries a Zacks Rank #5 (Strong Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>