biosimilar
FDA recommends Novartis’s biosimilar for Enbrel in unanimous vote
July 14, 2016Research and Development, Sales and Marketing Enbrel, FDA, Novartis, Sandoz, biosimilar
Sandoz, a division of Novartis, has announced that a US Food and Drug Administration (FDA) advisory committee has recommended their …
US FDA committee recommends approval for Amgen’s biosimilar of AbbVie’s Humira
July 13, 2016Research and Development, Sales and Marketing AbbVie, Amgen, Humira, US FDA, biosimilar, drug approval, drug trial, inflammatory diseases, rheumatoid arthritis
One of the world’s bestselling drug may soon have competition in the US markets after the regulators backed a biosimilar …
Coherus BioSciences says Neulasta biosimilar shows positive topline results; shares jump
July 12, 2016Manufacturing and Production, Research and Development, Sales and Marketing Amgen, Cancer, Coherus BioSciences, biosimilar, drug trial
Shares in Coherus BioSciences (Nasdaq: CHRS) jumped to close over 27% after the company said its biosimilar copy for Amgen’s …
Amgen’s Humira biosimilar candidate “highly similar” to originator, says FDA
July 8, 2016Research and Development, Sales and Marketing ABP-501, AbbVie, Amgen, FDA, Humira, abp 501, biosimilar
A report from a meeting of the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee has concluded that Amgen’s …
MSD insulin glargine biosimilar meets primary endpoint in late-stage trials
June 14, 2016Manufacturing and Production, Research and Development, Sales and Marketing MSD, Merck, biosimilar, insulin, insuline glargine
MSD (NYSE: MRK), known as Merck in the US and Canada, has announced results from two Phase III studies evaluating …
FDA to review data on Amgen’s Humira biosimilar
June 14, 2016Manufacturing and Production, Research and Development, Sales and Marketing Amgen, FDA, Humira, biosimilar
Amgen (NASDAQ: AMGN) has announced the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee will review data supporting the …
Mylan’s breast cancer biosimilar matches Roche’s Herceptin in Phase III trial
June 6, 2016Research and Development ASCO, Biocon, Herceptin, Mylan, Roche, biosimilar, breast cancer, trastuzumab
Mylan (NASDAQ: MYL) and Biocon (NSE: BIOCON) have presented data the 2016 American Society of Clinical Oncology (ASCO) annual meeting …
EU green-lights Samsung Bioepis, Biogen’s Remicade biosimilar Flixabi
May 31, 2016Manufacturing and Production, Research and Development, Sales and Marketing Biogen, Samsung Bioepis, biosimilar, drug trial, regulation, research
Samsung Bioepis and partner Biogen (Nasdaq: BIIB) said the European Commission has approved Flixabi, a biosimilar version of Johnson & …
Sandoz biosimilar accepted for regulatory submission by EMA
May 24, 2016Manufacturing and Production, Research and Development, Sales and Marketing EMA, Sandoz, biosimilar
Sandoz, a division of Novartis, has announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application for …
Sandoz receives EU approval for subcutaneous injection of Binocrit biosimilar
April 8, 2016Medical Communications, Research and Development Sandoz, binocrit, biosimilar, eu approval
Sandoz has received approval from the European Commission for a type II variation for the addition of a subcutaneous route …
Dr. Reddy’s, TR-Pharm to collaborate on 3 biosimilars in Turkey
March 11, 2016Manufacturing and Production, Medical Communications, Sales and Marketing Dr Reddy's Laboratories, TR-Pharm, biosimilar, generics, marketing collaboration
Three biosimilar products by the Indian generics company Dr. Reddy’s will be marketed by TR-Pharm in Turkey, the companies said …
Almost half of US physicians will prescribe more biosimilars, according to survey
March 4, 2016Medical Communications Obama, US, biosimilar, patent, prescribing
New data published by InCrowd has suggested that US physicians are very amenable to the prescription of biosimilars, with some …
FDA advisory committee recommends approval of Remicade biosimilar
February 10, 2016Research and Development, Sales and Marketing FDA, Pfizer, Remicade, biosimilar, celltrion
An FDA advisory panel yesterday voted overwhelmingly in favour of approving CT-P13- Celltrion’s biosimilar version of Johnson&Johnson’s blockbuster arthritis drug …
FDA to review Amgen’s Humira biosimilar
January 26, 2016Manufacturing and Production ABP-501, Amgen, FDA, biosimilar
The FDA has accepted for review Amgen’s Biologics License Application (BLA) for ABP 501, a biosimilar candidate to AbbVie’s Humira …
Baxalta’s Enbrel biosimilar measures up in late-stage study
January 13, 2016Research and Development Amgen, Baxalta, Enbrel, Pfizer, biosimilar, etanercept, rheumatoid arthritis
Having emerged from its mega-merger deal with Shire, Baxalta is back on its drug development day job – and has …
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