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Merck & Co., Samsung Bioepis introduce Remicade biosimilar Renflexis in US firstwordpharma
July 25, 2017
Merck & Co. and Samsung Bioepis on Monday announced the US launch of Renflexis (infliximab-abda).
Samsung Bioepis biosimilar wins tentative approval in US firstwordpharma
July 25, 2017
According to industry sources, Samsung Bioepis' biosimilar Lusduna Nexvue received tentative approval from the FDA, reported The Korea Herald.
Mylan-Biocon’s breast cancer biosimilar gets US FDA nod financialexpress
July 17, 2017
Mylan and Biocon’s proposed biosimilar trastuzumab also is under review by regulatory authorities in Australia, Canada, Europe and other emerging markets
Mylan-Biocon’s breast cancer biosimilar gets US FDA nod financialexpress
July 14, 2017
Mylan and Biocon’s proposed biosimilar trastuzumab also is under review by regulatory authorities in Australia, Canada, Europe and other emerging markets
BIOCAD’s rituximab biosimilar to receive MA in India cphi-online
July 06, 2017
First shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.
Pfizer’s biosimilar gets another FDA rejection biospectrumasia
June 28, 2017
FDA complete response letter (CRL) cited concerns about the same Pfizer fill-finish plant whose problems led the FDA to deny approval of a highly anticipated copy of Teva’s Copaxone that was to be finished there.
Biogen’s Imraldi, an adalimumab biosimilar candidate referencing Humira, granted positive opinion by cphi-online
June 27, 2017
If approved, Imraldi will be the third anti-TNF biosimilar in Biogen’s portfolio in Europe.
Pfizer’s biosimilar gets a second knock-back from FDA pharmafile
June 26, 2017
Pfizer’s biosimilar gets a second knock-back from FDA
Biosimilar trastuzumab candidate shown similar in efficacy and safety europeanpharmaceuticalreview
June 08, 2017
Data presented at the 2017 American Society of Clinical Oncology Annual Meeting has shown similarity in efficacy and safety between CT-P6 (biosimilar trastuzumab candidate) and...
FDA Advisory Committee recommends approval of Pfizer's proposed biosimilar to Epogen® / Procrit® acr worldpharmanews
May 27, 2017
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Company's proposed epoetin alfa biosimilar across all indications.

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