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Apr 4, 2025
On 4 April 2025, Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration…
Apr 3, 2025
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…
Apr 2, 2025
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…
Apr 2, 2025
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…
Apr 1, 2025
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)…
Apr 1, 2025
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)…
Apr 1, 2025
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…
Mar 31, 2025
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)…
Mar 31, 2025
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…
Mar 28, 2025
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…
Mar 28, 2025
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…
Mar 27, 2025
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…
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