Pharmafile Logo
Pharmafocus logo
Advanced Search

biosimilar

Showing 15 posts of 73 posts found.

merck_and_co

MSD’s Lantus biosimilar given conditional FDA approval

July 21, 2017
Medical 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, …

News
fda2outsideweb

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 …

News
novartis_side_building

UK launch of two Novartis biosimilars could cut NHS costs

June 27, 2017
Business 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 …

News
celltrion1

Celltrion biosimilar proves effectiveness in lymphoma and rheumatoid arthritis

June 14, 2017
Research 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 …

News
mylan

Mylan’s pathway to launch of biosimilar to Herceptin cleared by Roche

March 13, 2017
Manufacturing 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 …

News
abbvie_0

UK High Court rules against AbbVie’s Humira patents

March 6, 2017
Sales 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 …

News
celltrion

First biosimilar for European cancer treatment given approval

February 23, 2017
Sales 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 …

News
bi_german_building_at_night

Boehringer steps into Humira race with US and EU biosimilar filings

January 19, 2017
Sales 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 …

News
biocon_office

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 …

News

Pfizer announce positive results for Humira biosimilar

January 6, 2017
Medical 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 …

News
novartis_building

FDA approves Novartis Enbrel biosimilar

August 31, 2016
Research 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 …

News
lab

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 …

News
remicade_packshot

J&J loses Remicade patent fight, pledges to continue fight against biosimilars

August 18, 2016
Research 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 …

News
merck_and_co

MSD files Lantus biosimilar with FDA

August 8, 2016
Sales 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 …

News
clinical_trial_4

Phase III study confirms similarity of Herceptin biosimilar from Amgen, Allergan

July 22, 2016
Medical 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 …

News
The Gateway to Local Adoption Series

Latest content

BMS’ Opdivo/Yervoy combination accepted by Scottish Medicines Consortium for colorectal cancer

February 5, 2026

AstronauTx appoints Adam Rosenberg as Chair of the Board

February 5, 2026

Astellas Pharma’s Vyloy accepted by Scottish Medicines Consortium for gastric cancer

February 4, 2026

Angelini Pharma appoints Sergio Marullo di Condojanni as CEO

February 4, 2026

QV Bioelectronics secures £4.5m in funding for brain cancer therapy development

February 3, 2026