Showing 15 posts of 22 posts found.


India’s National Task Force rejects Biocon’s itolizumab for COVID-19

July 27, 2020
Sales and Marketing Biocon, COVID-19, India, Itolizumab

Biocon was hit with bad news over the weekend as the National Task Force for COVID-19 in its home country …


Mylan lands biosimilar sucker punch to Amgen’s blockbuster

June 6, 2018
Research and Development, Sales and Marketing Amgen, Biocon, Mylan, Neulasta

Mylan and Biocon have received FDA approval for their biosimilar to Amgen’s Neulasta (pegfilgrastim), setting the companies on track to …


FDA inspection reveals cGMP issues at Biocon’s major Malaysia facility

March 13, 2018
Manufacturing and Production Biocon, CGMP, FDA, pharma

Biocon’s insulin production facility in Johar, Malaysia – the largest integrated insulin manufacturing facility in Asia – has been slapped …


EMA committee recommends seven therapies from Roche, GSK, MSD and more

January 29, 2018
Sales and Marketing Biocon, Chiesi, Chugai, GSK, GlaxoSmithKline, MSD, Mylan, Roche, Sanofi, pharma

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has voiced its recommendation of a raft of …


Novartis enters biosimilar agreement with Biocon

January 19, 2018
Medical Communications, Sales and Marketing Biocon, Novartis, Sandoz, biosimilars, biotech, drugs, pharma, pharmaceutical

Novartis’ Sandoz unit had already staked a claim to being one of the leaders in the developing biosimilar market and …


Mylan and Biocon biosimilar approval expands to Brazil

January 2, 2018
Manufacturing and Production, Sales and Marketing Biocon, Herceptin, Mylan, biosimilar, biotech, drugs, pharma, pharmaceutical

Since Mylan and Biocon managed to gain US FDA approval for its Herceptin (Trastuzumab) biosimilar, it has forged ahead in …


Mylan’s Ogivri becomes first and only FDA-approved Herceptin biosimilar

December 4, 2017
Sales and Marketing Biocon, Cancer, FDA, Herceptin, Mylan, Roche, biosimilar, pharma

The FDA has announced the approval of Mylan’s Ogivri (trastuzumab-dkst), the first biosimilar version of Roche’s Herceptin to be authorised …


Mylan and Biocon Neulasta biosimilar knocked back by FDA

October 11, 2017
Research and Development, Sales and Marketing Amgen, Biocon, Mylan, Neulasta, biotech, drugs, pharma, pharmaceutical

Mylan and Biocon’s biosimilar version of Amgen’s blockbuster, Neulasta (pegfilgrastim), will have to wait a bit longer before getting the …


FDA unanimously recommends Mylan and Biocon’s Herceptin biosimilar

July 14, 2017
Manufacturing and Production, Medical Communications, Sales and Marketing Biocon, Herceptin, Mylan, biosimilar, biotech, drugs, healthcare, life sciences, pharma, pharmaceuticals

Mylan and Biocon have revealed that their biosimilar version of Roche and Genentech’s Herceptin (trastuzumab) has received unanimous recommendation from …


Problematic facility inspection puts Biocon’s biosimilar EU approvals on hold

July 10, 2017
Manufacturing and Production, Sales and Marketing Biocon, India, biosimilars

Indian firm Biocon has been hit by regulator criticism which has forced its European biosimilar programme on hold following a …


Mylan and Biocon apply to FDA for biosimilar approval

January 12, 2017
Sales and Marketing Biocon, FDA, Mylan, biosimilar, trastuzumab

Mylan, the US-based generics specialist, and Biocon, an Indian biopharmaceutical company, have applied for a biologics license application (BLA) for …


Major fire ravages Biocon subsidiary complex in India

December 13, 2016
Manufacturing and Production Biocon, Syngene

A subsidiary of Indian biopharmaceutical firm Biocon was gutted by a major fire at Electronic City, Bangalore on 12 December, …


EMA accepts regulatory submission for proposed Herceptin biosimilar

August 26, 2016
Medical Communications Biocon, EMA, Herceptin, Mylan, biosimilar, regulatory, submission, trastuzumab

Mylan and Biocon have announced that the European Medicines Agency (EMA) has accepted for review its marketing authorisation application for …

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 …

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