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European Commission okays Mylan, Biocon’s biosimilar of cancer drug
expressbpd
December 20, 2018
Ogivri is indicated for the treatment of patients with HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer
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Alvotech, Fuji Pharma Expand Biosimilars Alliance
contractpharma
December 19, 2018
Alvotech and Fuji Pharma have entered an exclusive agreement for the development and commercialization of biosimilars in Japan. Fuji is acquiring a 4.2% stake in Alvotech for approximately $50 million
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Celltrion/Teva’s Herceptin biosimilar approved in US
pharmaphorum
December 18, 2018
The FDA has approved Celltrion and Teva’s biosimilar of Roche’s breast cancer drug Herceptin, the second potential competitor to the cancer blockbuster in the US.
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Pfizer’s cut-price version of Avastin wins EU panel greenlight
expressbpd
December 18, 2018
Pfizer’s Zirabev is a cheaper version to Roche Holding’s leading cancer drug Avastin
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Pfizer receives positive CHMP opinion for oncology biosimilar, ZIRABEV™ (bevacizumab)
worldpharmanews
December 17, 2018
Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for ZIRABEV™ (bevacizumab).
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FDA approves biosimilar of blockbuster Humira
pharmaphorum
December 17, 2018
A Humira biosimilar, produced by drug maker Sandoz, has been given the green light from the US Food and Drug Administration (FDA)......
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FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin
drugs
December 17, 2018
Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb).....
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Prestige BioPharma Partners with Cipla Ltd to Market Key Cancer Biosimilar
b3cnewswire
December 17, 2018
Prestige BioPharma (“Prestige”) announced today that it has reached a licensing agreement with Cipla Limited (“Cipla”) for its trastuzumab biosimilar (HD201) under which......
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Mylan, Biocon copy inches closer to challenging Sanofi's long-suffering Lantus
fiercepharma
December 14, 2018
Sanofi’s Lantus is already facing off against generic competition from Eli Lilly and Boehringer’s Basaglar, but now Mylan is adding to the pressure by prevailing in a patent challenge at the U.S. Patent and Trademark Office.
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As competition heats up, U.S. prices for Remicade and biosims slip: analyst
fiercepharma
December 12, 2018
As Johnson & Johnson vies with biosimilars to its big-selling Remicade, prices across the category are gradually falling, an analyst says—and Pfizer's Inflectra has taken the biggest tumble.