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Nov 24, 2025
On 24 November 2025, Sandoz announced the UK launch of Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), with launches in major European markets such as Germany and France to follow, and additional European rollouts to occur in 2026.
Nov 21, 2025
On 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s antibody-drug conjugate Enhertu® (trastuzumab deruxtecan).
Nov 20, 2025
On 20 November 2025, Formycon and Bioeq jointly announced that their commercialisation partner, Sandoz, has launched Epruvy®, biosimilar to Genentech’s Lucentis®, in Germany.
Nov 20, 2025
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).
Nov 20, 2025
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 2026.
Nov 19, 2025
On 19 November 2025, Xbrane provided an update on the resubmissions of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter (CRL) received in October 2025.
Nov 19, 2025
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).
Nov 19, 2025
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.
Nov 19, 2025
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…
Nov 18, 2025
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).
Nov 18, 2025
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, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
Nov 17, 2025
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…
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