On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its February 2026 meeting, including positive opinions for 6 biosimilars: Shanghai Henlius/Organon’s Poherdy® (HLX11) (pertuzumab), Gedeon Richter’s Tuyory® (tocilizumab), Biocon’s Fubelv® (etanercept), Sandoz/Gan & Lee’s Bysumlog® (insulin lispro) and Dazparda® (insulin aspart), and CinnaGen’s Zandoriah™ (teriparatide).
Shanghai Henlius/Organon’s Poherdy® (HLX11), biosimilar to Genentech/Roche’s Perjeta® (pertuzumab), is indicated for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer. Under a June 2022 deal, Organon has exclusive global commercialisation rights for Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”. Poherdy® received FDA approval in November 2025 and Henlius/Organon settled BPCIA litigation relating to pertuzumab with Genentech/Roche in January 2026.
Richter’s Tuyory® (RGB-10), biosimilar to Roche’s RoActemra® (tocilizumab) was recommended by CHMP across multiple indications. Tuyory® was jointly developed by Richter and Mochida Pharmaceutical, with Mochida being responsible for regulatory filings in Japan and Richter filing marketing authorisation applications in other countries. There are 3 tocilizumab biosimilars approved in Europe: Fresenius Kabi’s Tyenne® (November 2023), STADA’s Tocilizumab STADA™ (previously Biogen’s Tofidence®) (June 2024) and Celltrion’s Avtozma® (February 2025).
Fubelv®, biosimilar to Pfizer’s Enbrel® (etanercept) is Biocon’s second etanercept brand in the EU. The first, Nepexto® was EU approved in 2020 (with Lupin being the marketing authorisation holder at that time).
Gan & Lee’s Bysumlog®, biosimilar to Eli Lilly’s Humalog® (insulin lispro) and Dazparda®, biosimilar to Novo Nordisk’s Novolog® (insulin aspart), will be commercialised in Europe by Sandoz under a December 2018 agreement.
CinnaGen’s Zandoriah™, biosimilar to Eli Lilly’s Forteo® (teriparatide), will join a number of other teriparatide biosimilars registered in Europe, including Richter’s Terrosa® (approved in 2017). A previous application for EU approval of a teriparatide biosimilar was withdrawn by CinnaGen in September 2021.