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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.

TOT Biopharm releases results of Phase I study of proposed BmAb biosimilar, reporting PK similarity and safety in comparison to the originator.

Sandoz and Polpharma announced they have entered into a licensing deal for Polpharma’s natalizumab biosimilar.  Under the agreement, Polpharma will develop, manufacture and supply the product, while Sandoz will be responsible for commercialisation and distribution.

Celltrion announces patnership with Lonza for the production of Remsima®. Lonza will now work within Celltrion’s network to complement Celltrion’s own production capacity.

US Patent and Trial Board commences an inter partes review of Alexion’s eculizumab patents following Amgen’s claims that they were anticipated or obvious.