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On 13-14 January 2025, Eisai and Biogen announced that the US FDA has accepted Eisai’s Biologics Licence Application (BLA) for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for the treatment of Alzheimer’s disease in patients with M...

On 13 January 2025, Shanghai Henlius announced that it has entered a product licence and supply agreement with Abbott under which Abbott is granted exclusive or semi-exclusive rights to the commercialisation of four biosimilars and one innovative biologic.  The commercialis...

At the JP Morgan Annual Healthcare conference on 13 January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) in Phase 3 trials.  The Phase 3 study (NCT06700343), which begins enrolment this month in the US, is aimed at demonstrating pharmacokin...

On 13 January 2025, Teva Pharmaceuticals announced that it has entered into a strategic collaboration agreement with Klinge Biopharma and Formycon for the commercialisation of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in Europe (excluding Ital...

On 10 January 2025, Samsung Bioepis and Teva announced they have entered into a licence, development and commercialisation agreement for Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris® (eculizumab), in the US.

Under the agreement, Samsung Bioepis will be...

On 10 January 2025, New Zealand’s Pharmac announced that it will be expanding access to Amgen’s Prolia® and Xgeva® (denosumab).

Both Xgeva® (70mg/ml solution for injection, for various bone-related cancer indications) and Prolia® (60mg/ml, for severe osteoporosis) ar...

On 9 January 2025, Astellas Pharma announced that Health Canada has approved Vyloy® (zolbetuximab for injection) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or m...

On 9 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted its nipocalimab Priority Review designation for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalised myasthenia gravis (gMG), as supported by f...