On 22 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its May 2026 meeting, including positive opinions for one biosimilar, one “hybrid” medicine and recommended extended indications for a number of biopharmaceuticals.
Lupin’s Vislyfa® (ranibizumab), biosimilar to Genentech’s Lucentis®, was the only biosimilar to receive a positive opinion this month. There is already a Lupin-developed biosimilar approved in Europe, Ranluspec® (approved February 2026, with planned EU launch in the second half of 2026). Under an August 2025 agreement, Sandoz is commercialising Ranluspec® in the EU (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam and Malaysia. Other ranibizumab biosimilars approved and launched in Europe include Samsung Bioepis’ Byooviz® (approved August 2021 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) and Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva). Intas’ Rexatilux® (ranibizumab) received a positive CHMP opinion in April 2026.
STADA received positive recommendations for its “hybrid” liraglutide products Ablymico® and STADA Liraglutide™, indicated for weight management and type 2 diabetes, respectively. The EMA categorises a medicine as “hybrid” where it is similar to an authorised medicine containing the same active substance, but where there are certain differences between the two medicines such as in their strength, indication or pharmaceutical form. Ablymico® is a hybrid medicine of Novo Nordisk’s Saxenda® (liraglutide), in that it contains the same active substance, but it is chemically synthesised, whereas the active substance of Saxenda® is of biological origin. For the same reason, STADA Liraglutide™ is a hybrid medicine of Novo Nordisk’s Victoza® (liraglutide).
The CHMP’s May 2026 positive opinions for extended indications include:
- AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan): for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options;
- MSD’s Erbitux® (cetuximab): for adults with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib and FOLFOX for first line treatment and in combination with encorafenib in patients who have received prior systemic therapy;
- AstraZeneca’s Fasenra® (benralizumab): as an add‑on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause;
- Shanghai Henlius/Accord’s Hetronifly® (serplulimab): in combination with carboplatin and nab-paclitaxel, for first-line treatment of adults with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma;
- MSD’s Keytruda® (pembrolizumab): in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for treatment of adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy;
- MSD’s Keytruda SC™ (pembrolizumab and berahyaluronidase-alfa): indications extended to adolescents in relation to melanoma and classical Hodgkin Lymphoma; and
- Astellas’ Padcev® (enfortumab vedotin): in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
Celltrion withdrew its EU marketing authorisation application for Veblocema™ (infliximab) for the treatment of rheumatoid arthritis, Crohn’s disease and ulcerative colitis “due to a change in business strategy”, while Laboratoires Delbert withdrew its application for Orblid™ (bevacizumab) for treatment of hereditary haemorrhagic telangiectasia, due to identification of major clinical issues which could only be addressed by carrying out a new clinical study.