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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.

JHL announces it will immediately cease development and clinical trials of a number of biosimilars including rituximab, trastuzumab and bevacizumab as part of a settlement deal with Genentech. This agreement settles the 2018 dispute between the two parties, in which it was ...

Alexion reveals that the EPO denied two patent applications relating to its eculizumab product, as they await the full written response.

Australia’s TGA approves Ziextenzo® in 6mg/0.6mL solution for injection prefilled syringe for the treatment of cancer patients following chemotherapy.