Read our latest updates & insights

On 20 November 2025, Alvotech and Advanz Pharma announced that the European Commission has granted marketing authorisations in the European Economic Area for Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab).  The approval covers both pre-filled syringe and aut...

On 20 November 2025, Accord BioPharma announced that it has received FDA approval for Osvyrti® and Jubereq®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications.  Accord plans to launch the denosumab biosimilars in the US in 20...

On 19 November 2025, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter (CRL) received in October 2025.  Xbrane expects to be able to resubmit its BLA in March 2026 following completion of correcti...

On 19 November 2025, MSD announced that that the European Commission has approved its subcutaneous (SC) formulation of Keytruda®, to be marketed in the EU as Keytruda SC™ (pembrolizumab and berahyaluronidase alfa-pmph).  The marketing authorisation covers all 33 previously ...

On 19 November 2025, Regeneron announced that the FDA has approved Eylea HD® (aflibercept, 8mg for injection) for macular oedema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period.  A 4-weekly dosing option has also ...

On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be considered for reimbursement:

Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syrin...

On 18 November 2025, Celltrion announced that it has received European Commission approval for a new 300 mg (2 mL) prefilled syringe form of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  According to Celltrion, the additional strength of Omlyclo® “can significant...

On 18 November 2025, Celltrion announced that the European Commission has approved its Remsima™ IV liquid formulation for all approved indications of the powder formulation, including rheumatoid arthritis, adult and paediatric Crohn’s disease and ulcerative colitis, ankylos...

On 17 November 2025, Formycon revealed that it is developing FYB208, a biosimilar candidate to Sanofi/Regeneron’s Dupixent® (dupilumab).  According to Formycon, preclinical development is completed and it is working on the study design for the planned clinical pharmacokinet...