On 3 April 2025, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved by New Zealand’s Medsafe for the same indications as its reference product…
On 2 April 2025, Johnson & Johnson announced that the European Commission has approved Stelara® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in…
Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu®, are to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting…
On 1 April 2025, Eisai reported that the final process for the European Commission (EC) regulatory review of Eisai’s Marketing Authorisation Application (MAA) for Leqembi® (lecanemab)…
On 1 April 2025, the European Medicines Agency (EMA) published a draft reflection paper questioning whether biosimilars may be approved in future without submission of Comparative Efficacy Studies (CES)…
On 1 April 2025, Organon announced that it has acquired from Biogen the US regulatory and commercial rights to Tofidence™, biosimilar to Roche’s Actemra® (tocilizumab). Product developer Bio-Thera Solutions will continue to manufacture the product…
Korea Medical Review reported on 31 March 2025 that Celltrion has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) regarding its autoinjector formulation of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab)…
On 31 March 2025, Celltrion’s Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by Australia’s Therapeutic Good’s Administration (TGA) as follows…
On 28 March 2025, the US FDA approved AstraZeneca’s Imfinzi® (durvalumab) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment…
On 28 March 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency (EMA) has validated their marketing authorisation application (MAA) for HLX11…
On 27 March 2025, Roche’s subcutaneous Ocrevus® (ocrelizumab) was listed on the Australian Register of Therapeutic Goods (ARTG). This adds to the intravenous formulation of Ocrevus® listed on the ARTG in July 2017…
On 27 March 2025, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare…
At its March meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions for seven indication expansions…
On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s…
On 27 March 2025, MSD announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab…
At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars…