Blog Archives | Page 28 of 102

Recent BioBlast® Updates

Approval Alert: Samsung Bioepis’ Denosumab Biosimilar Approved in South Korea

Apr 6, 2025

On 6 April 2025, ChosunBiz reported that Samsung Bioepis has received approval in South Korea for Obodence™, biosimilar to Amgen’s Prolia® (denosumab)…

Approval Alert: Amgen’s Biosimilar Aflibercept Approved in EU

Apr 4, 2025

On 4 April 2025, the European Commission granted marketing authorisation to Amgen’s Pavblu®(aflibercept 2mg), biosimilar to Bayer/Regeneron’s Eylea® for nAMD and visual impairment…

Approval Alert: Sandoz’s Tyruko® is First Natalizumab Biosimilar Approved in Australia

Apr 4, 2025

On 4 April 2025, Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), was approved by Australia’s Therapeutic Goods Administration (TGA). This is the first biosimilar natalizumab…

Approval Alert: Celltrion’s Denosumab Biosimilars AU Approved

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…

Approval Alert: Celltrion’s Omlyclo® is First Omalizumab Biosimilar Approved in NZ

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…

New Indication Alert: J&J’s Stelara® (Ustekinumab) EU Approved for Paediatric Use in Crohn’s Disease

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…

Sandoz’s Aflibercept Biosimilars on Australia’s July PBAC Agenda

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…

Leqembi® (Lecanemab-irmb) European Update

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)…

EMA Reconsiders Need for Biosimilar Comparative Efficacy Studies; Invites Stakeholder Comments

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)…

Organon Acquires US Rights to Biogen’s Tocilizumab Biosimilar

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…

Positive CHMP Opinion for Celltrion’s Omalizumab Autoinjector

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)…

Approval Alert: Celltrion’s Eydenzelt® First Aflibercept Biosimilar AU Approved

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…