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Australia’s TGA approved Kyowa Kirin’s Crysvita® (burosumab) for the treatment of X-linked hypophosphataemia.

Alvotech announced positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®. Alvotech reported that no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and ...

BioFactura announced it has reached an agreement with Rani Therapeutics to assess BFI-751 (proposed ustekinumab biosimilar) in combination with the RaniPill® platform. The RaniPill® capsule is intended to replace subcutaneous or IV injection of biologics with oral dosing.

Samsung Bioepis announced results from a post-hoc and subgroup analysis of a Ph III clinical study of Byooviz® (ranibizumab biosimilar). Samsung Bioepis reported that the data supports biosimilarity between Byooviz® and reference ranibizumab.

Bio-Thera Solutions announced that it has entered into a commercialisation and license agreement with Sandoz to commercialise BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Sandoz will commercialise the product in the US, Europe, Canada and other internatio...

The EMA approved Samsung Bioepis and Biogen’s Byooviz® (biosimilar ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular oedema, proliferative diabetic retinopathy, macular edema and choroidal neovascularisation.

Adaptimmune Therapeutics announced it has entered into a strategic collaboration and license agreement with Genentech to develop and commercialise allogeneic cell therapies for multiple oncology indications.

Fresenius Kabi announced that its biosimilar tocilizumab candidate MSB11456 successfully met its primary and secondary endpoints in Ph I trials of both subcutaneous and intravenous formulations.