CHMP adopts positive opinion on Donrafylix
On 12 November 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for Donrafylix, a biosimilar insulin aspart intended for the treatment of diabetes mellitus. The applicant is Kuraci BV and Donrafylix will be available as a 100 units/ml solution for injection.
Primary source
EMA medicine page (CHMP opinion), November 13, 2026
Donrafylix (insulin aspart): EMA CHMP opinion
Read the source: Donrafylix (insulin aspart): EMA CHMP opinion ema.europa.eu
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