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biosimilar

Showing 15 posts of 73 posts found.

FDA recommends Novartis’s biosimilar for Enbrel in unanimous vote

July 14, 2016
Research 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 …

News
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US FDA committee recommends approval for Amgen’s biosimilar of AbbVie’s Humira

July 13, 2016
Research 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 …

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cancerstudy

Coherus BioSciences says Neulasta biosimilar shows positive topline results; shares jump

July 12, 2016
Manufacturing 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 …

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amgen_hq

Amgen’s Humira biosimilar candidate “highly similar” to originator, says FDA

July 8, 2016
Research 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 …

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merckincweb

MSD insulin glargine biosimilar meets primary endpoint in late-stage trials

June 14, 2016
Manufacturing 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 …

News
amgen_flag

FDA to review data on Amgen’s Humira biosimilar

June 14, 2016
Manufacturing 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 …

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Mylan’s breast cancer biosimilar matches Roche’s Herceptin in Phase III trial

June 6, 2016
Research 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 …

News
samsung_bioepis

EU green-lights Samsung Bioepis, Biogen’s Remicade biosimilar Flixabi

May 31, 2016
Manufacturing 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 & …

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Sandoz biosimilar accepted for regulatory submission by EMA

May 24, 2016
Manufacturing 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 …

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Sandoz receives EU approval for subcutaneous injection of Binocrit biosimilar

April 8, 2016
Medical 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 …

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Dr. Reddy’s, TR-Pharm to collaborate on 3 biosimilars in Turkey

March 11, 2016
Manufacturing 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 …

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magic_bullets_pills

Almost half of US physicians will prescribe more biosimilars, according to survey

March 4, 2016
Medical 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 …

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FDA advisory committee recommends approval of Remicade biosimilar

February 10, 2016
Research 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 …

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FDA to review Amgen’s Humira biosimilar

January 26, 2016
Manufacturing 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 …

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Baxalta’s Enbrel biosimilar measures up in late-stage study

January 13, 2016
Research 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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