biosimilar
MSD’s Lantus biosimilar given conditional FDA approval
July 21, 2017Medical Communications, Sales and Marketing FDA, MSD, Sanofi, biosimilar, biotech, drugs, pharma, pharmaceutical
MSD, known as Merck in North America, has been granted approval for its biosimilar of Sanofi’s diabetes treatment, Lantus. Potentially, …
FDA unanimously recommends Mylan and Biocon’s Herceptin biosimilar
July 14, 2017Manufacturing 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 …
UK launch of two Novartis biosimilars could cut NHS costs
June 27, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Erelzi, Novartis, Rixathon, Sandoz, biosimilar, etanercept, rituximab
Sandoz, a division of Swiss pharma giant Novartis, has revealed that two of its biosimilars – Rixathon (biosimilar rituximab) and …
Celltrion biosimilar proves effectiveness in lymphoma and rheumatoid arthritis
June 14, 2017Research and Development Cellltrion, Truxima, biosimilar, lymphoma, rheumatoid arthritis, rutiximab
Celltrion Healthcare has revealed new data which validates its biosimilar Truxima (CT-P10) as non-inferior to its reference product rituximab in …
Mylan’s pathway to launch of biosimilar to Herceptin cleared by Roche
March 13, 2017Manufacturing and Production, Sales and Marketing Genentech, Herceptin, Mylan, Roche, biosimilar
Mylan scored a big victory in its plan to launch its biosimilar to Roche’s blockbuster, Herceptin, after Roche and itself …
UK High Court rules against AbbVie’s Humira patents
March 6, 2017Sales and Marketing AbbVie, Biogen, Fujifilm Kyowa Kirin Biologics, Humira, Samsung Bioepis, biosimilar
The UK High Court has ruled that two of AbbVie patents, related to dosing regimens for rheumatoid arthritis, psoriasis and …
First biosimilar for European cancer treatment given approval
February 23, 2017Sales and Marketing biosimilar, celltrion
The first biosimilar will be made available in Europe to match the indications of Roche’s best-selling cancer drug, Rituxan. The …
Boehringer steps into Humira race with US and EU biosimilar filings
January 19, 2017Sales and Marketing Boehringer Ingelheim, Humira, biosimilar
Boehringer Ingelheim has just stepped into the ring to battle it out for a slice of Humira’s revenue with accepted …
Mylan and Biocon apply to FDA for biosimilar approval
January 12, 2017Sales 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 …
Pfizer announce positive results for Humira biosimilar
January 6, 2017Medical Communications, Research and Development, Sales and Marketing Humira, Pfizer, biosimilar
Pfizer has released the successful Phase 3 results to its biosimilar to AbbVie’s blockbuster Humira, meeting its primary endpoint in …
FDA approves Novartis Enbrel biosimilar
August 31, 2016Research and Development, Sales and Marketing Enbrel, FDA, Novartis, Sandoz, biosimilar, erzeli
Novartis, through its Sandoz division, has announced that the FDA has approved Erelzi (etanercept-szzs), a biosimilar of Amgen’s blockbuster drug …
EMA accepts regulatory submission for proposed Herceptin biosimilar
August 26, 2016Medical 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 …
J&J loses Remicade patent fight, pledges to continue fight against biosimilars
August 18, 2016Research and Development, Sales and Marketing Johnson and Johnson, Remicade, biosimilar, biosimilars, infliximab, patent
Johnson and Johnson has announced that it has lost in a patent dispute between biosimilar makers Celltrion and Hospira, relating …
MSD files Lantus biosimilar with FDA
August 8, 2016Sales and Marketing FDA, Lantus, MK-1293, MSD, application, biosimilar
MSD, known as Merck in the US and Canada, has filed a new drug application with the US Food and …
Phase III study confirms similarity of Herceptin biosimilar from Amgen, Allergan
July 22, 2016Medical Communications, Research and Development Allergan, Amgen, Herceptin, Roche, biosimilar, trastuzumab
Amgen and Allergan have announced the results from a Phase III study investigating ABP 980, their biosimilar candidate for Roche’s …
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