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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.

NHS announces saving of £110 million by using AmAb biosimilars since AbbVie’s Humira® lost patent protection in October 2018.

Results of Phase III trial of proposed adalimumab biosimilar demonstrate therapeutic equivalence in terms of efficacy, safety and immunogenicity. The results, published in the first issue of the Lancet Rheumatology, support Innovent’s bid to launch the first biosimila...