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Pfizer's (PFE) Biosimilar of Avastin Gets Positive CHMP Nod
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Pfizer Inc. (PFE - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending marketing authorization for Zirabev (bevacizumab), a biosimilar version of Roche’s (RHHBY - Free Report) cancer drug Avastin. An application seeking approval of a biosimilar version of Avastin is under review in the United States as well.
Pfizer is looking to get Zirabev approved for the treatment of several cancer indications, for which the reference product is approved like colon cancer,metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), among others.
The regulatory application is supported by positive results of the phase III REFLECTIONS B739-03 comparative study, which showed clinical equivalence and found no clinically meaningful differences between Zirabev and Avastin in patients with advanced non-squamous NSCLC. Zirabev has been studied in about 400 subjects in the REFLECTIONS study.
Shares of the company have increased 25.2% compared with the industry’s growth of 8.4% year to date.
Zirabev is Pfizer’s second therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA in 2018. A biosimilar version of Roche’s Herceptin was approved in the EU in July 2018. In Europe, Pfizer already markets biosimilar versions of Amgen’s (AMGN - Free Report) drugs, Neupogen and Epogen.
In the United States, a biosimilar of Neupogen was launched in late September, while a biosimilar version of Epogen was approved in May 2018. Other than Avastin Biosimilar versions of Roche’s cancer drugs, Rituxan and Herceptin are also under review in the United States. The FDA’s decision on all these candidates are expected in 2019.
Separately, Pfizer also initiated a phase III study on its 20-Valent pneumococcal conjugate vaccine candidate, PF-06482077, for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults aged 18 years or older. Please note that PF-06482077 received Breakthrough Therapy Designation by the FDA in September 2018.
Bristol-Myers’ earnings per share estimates have increased from $3.64 to $3.87 for 2018 and $3.94 to $4.14 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 11.99%.
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.
Pfizer's (PFE) Biosimilar of Avastin Gets Positive CHMP Nod
Pfizer Inc. (PFE - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending marketing authorization for Zirabev (bevacizumab), a biosimilar version of Roche’s (RHHBY - Free Report) cancer drug Avastin. An application seeking approval of a biosimilar version of Avastin is under review in the United States as well.
Pfizer is looking to get Zirabev approved for the treatment of several cancer indications, for which the reference product is approved like colon cancer,metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), among others.
The regulatory application is supported by positive results of the phase III REFLECTIONS B739-03 comparative study, which showed clinical equivalence and found no clinically meaningful differences between Zirabev and Avastin in patients with advanced non-squamous NSCLC. Zirabev has been studied in about 400 subjects in the REFLECTIONS study.
Shares of the company have increased 25.2% compared with the industry’s growth of 8.4% year to date.
Zirabev is Pfizer’s second therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA in 2018. A biosimilar version of Roche’s Herceptin was approved in the EU in July 2018. In Europe, Pfizer already markets biosimilar versions of Amgen’s (AMGN - Free Report) drugs, Neupogen and Epogen.
In the United States, a biosimilar of Neupogen was launched in late September, while a biosimilar version of Epogen was approved in May 2018. Other than Avastin Biosimilar versions of Roche’s cancer drugs, Rituxan and Herceptin are also under review in the United States. The FDA’s decision on all these candidates are expected in 2019.
Separately, Pfizer also initiated a phase III study on its 20-Valent pneumococcal conjugate vaccine candidate, PF-06482077, for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults aged 18 years or older. Please note that PF-06482077 received Breakthrough Therapy Designation by the FDA in September 2018.
Pfizer Inc. Price
Pfizer Inc. Price | Pfizer Inc. Quote
Zacks Rank and Stock to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).
A better-ranked stock worth considering is Bristol-Myers Squibb Company (BMY - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $3.64 to $3.87 for 2018 and $3.94 to $4.14 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 11.99%.
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 >>