EMA CHMP Recommends Eight New Approvals in May 2026, Including Conditional MA and Biosimilar

Eight positive opinions from EMA's Committee for Medicinal Products for Human Use (CHMP) at its 18–21 May 2026 meeting expand the EU authorised medicines landscape across oncology, pulmonology, ophthalmology, and rare disease, with manufacturing and regulatory teams now tracking dossier requirements across three distinct application pathways.

The headline new molecular entity is Jascayd (nerandomilast), recommended for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, two indications with historically limited treatment options. A conditional marketing authorisation was granted for Vijoice (alpelisib) in PIK3CA-related overgrowth spectrum disorders, a rare genetic condition with no previously authorised therapy. Conditional MAs carry post-authorisation obligations; manufacturing sites supplying these products should anticipate accelerated pharmacovigilance timelines and specific labelling requirements under Article 14-a of Regulation (EC) No 726/2004.

Three hybrid applications cleared the committee: Ablymico (liraglutide) for weight management, Liraglutide STADA for type 2 diabetes, and Colchicine AGEPHA Pharma for secondary prevention of atherothrombotic events. Hybrid applications rely on a combination of reference product data and new clinical evidence, meaning QA and regulatory affairs teams will need to confirm that comparability packages and any divergent manufacturing processes are fully documented against the authorised reference product's specifications.

The single biosimilar opinion, Vislyfa (ranibizumab) for vision-impairing eye diseases, adds to the EU's ophthalmic biosimilar roster. For plant heads managing fill-finish operations in this space, the approval signals continued regulatory confidence in ranibizumab biosimilar development programmes, provided sterility assurance and extractables and leachables data meet the reference product benchmark.

The committee issued one negative opinion, declining to recommend Deqtynet (copper 64Cu oxodotreotide) for PET imaging of neuroendocrine tumours. Two applications were withdrawn before opinion: Orblid (bevacizumab) for hereditary haemorrhagic telangiectasia and Veblocema (infliximab) for rheumatoid arthritis, Crohn's disease, and ulcerative colitis. Withdrawal at this stage typically reflects unresolved major objections and carries implications for any contract manufacturing organisations supporting those programmes.

Thirteen already-authorised products received positive opinions on extensions of therapeutic indication, including Keytruda, Enhertu, Padcev, and Trodelvy, a volume of label updates that will require coordinated variation submissions and corresponding CMC section reviews across multiple sites.

The next CHMP plenary is scheduled for June 2026, at which point outstanding post-authorisation measures tied to the conditional MA for Vijoice will represent an early compliance checkpoint for the marketing authorisation holder's manufacturing network.

Source: European Medicines Agency (EMA) via ema.europa.eu, 22 May 2026.