On 24 April 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its April 2026 meeting, including positive opinions for one biosimilar and for extended indications of 9 already approved medicines.
Intas’ Rexatilux® (ranibizumab), biosimilar to Genentech’s Lucentis®, was the only biosimilar to receive a positive CHMP opinion in April. It will join a number of ranibizumab biosimilars approved and launched in Europe, including Samsung Bioepis’ Byooviz® (approved August 2021 in vial form and 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 Sandoz/Lupin’s Ranluspec® (approved February 2026, with planned EU launch in the second half of 2026).
CHMP positive opinions for extended indications include the following for BMS’ Opdivo® (nivolumab): in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL). The same indication was approved by the FDA in March 2026. BMS also added a cHL indication to its European registration in March 2026, with approval for nivolumab in combination with brentuximab vedotin for the treatment of relapsed or refractory cHL after one prior line of therapy. A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.
AbbVie’s Skyrizi® (risankizumab) also secured a positive recommendation for an extended indication, in respect of paediatric plaque psoriasis. The last indication approved for Skyrizi® in Europe was in July 2024, with ulcerative colitis being added to adult plaque psoriasis, psoriatic arthritis and moderate to severe Crohn’s disease. There have not been any announcements of any significant biosimilar risankizumab development.