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On 26 November 2025, Boan Biotech announced that Boyoujing® (BA9101), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by China’s National Medical Products Administration (NMPA) for the treatment of nAMD and DME (in IV form).  The approval follows acceptan...

On 25 November 2025, Prestige Biopharma announced that it has entered into an exclusive license and supply agreement with Biosidus for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a variety of Latin American markets including Arge...

On 25 November 2025, Shanghai Henlius announced that the first subject has been dosed in a phase I multi-centre clinical trial of its ipilimumab biosimilar, HLX13, referencing BMS’ Yervoy®.

The investigational new drug applications under trial have been approved by t...

On 25 November 2025, Sanofi and Regeneron announced that the European Commission has approved an indication extension to Dupixent® (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above wit...

On 24 November 2025, Formycon and Italian based pharmaceutical manufacturer NTC, jointly announced that Klinge Biopharma, the exclusive owner of the global commercialisation rights of Formycon’s aflibercept biosimilar, FYB203/Baiama®, finalised an exclusive commercialisatio...

On 24 November 2025, consent orders were made by the US District Court for the District of New Jersey recording that Hikma Pharmaceuticals and Gedeon Richter have entered into a confidential settlement agreement with Amgen to resolve pending BPCIA patent litigation in relat...

On 24 November 2025, Sandoz announced the UK launch of Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), with launches in major European markets such as Germany and France to follow, and additional European rollouts to occur in 2026.

Afqlir® was the seco...

On 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s antibody-drug conjugate Enhertu® (trastuzumab deruxtecan).  According to the report, the biosimilar is still...