Biosimilar - International Biopharmaceutical Industry

news

Input on Biosimilar Product Development Guidance Documents Sought by FDA

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Pla...

29 July 2024 news Biosimilar | FDA

Continue Reading →

news

In a first, FDA approves an ‘interchangeable’ biosimilar for diabetes

The promise of biosimilars — that competition would bring down the prices of complex biological drugs — hasn't materialized in the U.S. in the way many expected. Comp...

5 August 2021 news ABBVIE | Amgen

Continue Reading →

news

Lupin, Mylan to commercialize Enbrel Biosimilar

Under the terms of the agreement, Lupin will receive an up-front payment of $15 million. Pharma major Lupin Limited and global pharmaceutical company Mylan have a...

29 June 2018 news Biosimilar | commercialize

Continue Reading →

news

Pfizer Receives CRL for Biosimilar to Roche’s Herceptin

On April 23, 2018, Pfizer announced that it received a complete response letter (CRL) from FDA in response to the biologics license application (BLA) for the company’...