On 16 October 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its October 2026 meeting, including positive opinions for two biosimilars and expanded indications for a number of biopharmaceuticals.
Recommended Biosimilars
The CHMP adopted a positive opinion for Accord Healthcare’s biosimilar to Genentech’s Lucentis® (ranibizumab) under the brand name Fovlussea® (10 mg/ml solution for injection). Accord’s parent company, Intas, received a positive CHMP opinion in April 2026 for another ranibizumab biosimilar brand, Rexatilux®.
Ranibizumab biosimilars already approved and launched in Europe include Samsung Bioepis’ Byooviz® (approved August 2021, commercially available in several European countries since March 2023), STADA/Xbrane’s Ximluci® (launched in the EU in April 2023, following November 2022 approval), Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva), and Lupin’s Ranluspec® (approved February 2026, commercialised in Europe (excluding Germany) by Sandoz, with planned EU launch in the second half of 2026). Lupin’s Vislyfa® (ranibizumab) was recommended by the CHMP in May 2026.
The second biosimilar recommended by CHMP in October 2026 is CuraTeQ’s Neuzafy™, biosimilar to Amgen’s Neupogen® (filgrastim). This is the second biosimilar filgrastim brand for CuraTeQ in Europe, with Zefylti® approved by the European Commission in December 2025.
Recommended Indication Expansions
The CHMP’s October 2026 recommendations for extended indications include:
- Novo Nordisk’s Kyinsu® (insulin icodec, semaglutide) for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products;
- AstraZeneca’s pandemic influenza vaccine (H5N1) for active immunisation against influenza in an officially declared pandemic situation; and
- Janssen’s Talvey® (talquetamab) in combination with daratumumab and pomalidomide or in combination with daratumumab, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least one prior therapy.