Biosimilar and biologic updates include approvals, review decisions and licensing deals
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
On 21 April 2026, Biocon announced that, on 3 April 2026, Health Canada approved Bosaya™ and Vevzuo™, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively. On 21 April 2026, Roche announced that the FDA has accepted its supplemental Biologics License Application for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of an unspecified indication, and on 21 April 2026, Celltrion announced that the intravenous formulation of Steqeyma® (ustekinumab), biosimilar to Stelara®, has been approved in Japan.
On 20 April 2026, Astellas Pharma and Pfizer announced that the FDA granted priority review of the sBLA for Padcev™ (enfortumab vedotin-ejfv) in combination for an unspecified indication. On 22 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for the treatment of children aged 2 to 11 years with chronic disease.
On 12 February 2026, Arrotex Pharmaceuticals and Pfizer Australia entered into a commercial partnership for Enbrel® (etanercept). On 11 February 2026, the Supreme Court of India dismissed the Special Leave Petition of BMS requesting an appeal from the decision of the High Court of Delhi appellate bench in a nivolumab matter.
On 11 February 2026, Formycon and Taiwan-based Lotus Pharmaceutical announced they have concluded an exclusive licence agreement in relation to the commercialisation of a pembrolizumab product. During its Q3 FY26 earnings call on 10 February 2026, Zydus Lifesciences indicated that it is hoping to be the first to file a Biologics Licence Application in the US for a pembrolizumab product, and on 3 February 2026, Bio-Thera Solutions and Saudi-based Avalon Pharma announced that they have entered commercialisation and licence agreements for BAT3306.
On 11 February 2026, Celltrion announced that it received approval from the European Medicines Agency to reduce patient numbers enrolled in its global Phase 3 clinical trial for secukinumab. On 12 February 2026, Australia’s Pharmaceutical Benefits Advisory Committee updated its March 2026 agenda to include an ustekinumab item.