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Celltrion and Juno announce Australian co-marketing partnership agreement for Herzuma® (trastuzumab) and Truxima® (rituximab). Under the agreement, Celltrion will hold the marketing authorisation and will be responsible for distribution, and Juno will provide sales promotio...

FDA issues a complete response letter for Tanvex’s proposed filgrastim biosimilar. Tanvex has announced that the FDA did not request additional clinical data or express concern related to product safety, but that certain items needed to be addressed before the applica...

Biocon announces purchase of 60,000 square foot R&D site from Pfizer. The site in Chennai, India will house 250 scientists and is expected to be operational in a few months.

CMHP adopts positive opinion for additional indication for Remsima®, to include the treatment of rheumatoid arthritis.

Innovent releases results of Phase III clinical trials of bevacizumab biosimilar, reporting no statistical difference in media progression-free survival rates.

Dr Reddy’s commences enrolment for Phase III trials of biosimilar rituximab

iBio announces it has entered into an initial “Statement of Work” under its MOU with AzarGen Biotechnologies. iBio will manufacture research quantities of a plant-made rituximab using iBio’s proprietary FastPharming™ System.

Celltrion announces Canadian approval for its biosimilar trastuzumab, Herzuma®, for the treatment of HER-2 positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

Samsung Bioepis announces Brazilian approval for Brenzys®. For the first 10 years, Samsung Bioepis willl supply the drug to local distributors, during which a technology transfer with local partners will take place, allowing local partners to take over manufacturing after t...

Janssen announces EC approval for additional indication for Stelara®. Stelara® is now indicated for the treatment of ulcerative colitis.