Aurobindo Pharma has achieved a significant milestone with the European Commission (EC) granting marketing authorization for Dyrupeg™, a pegylated filgrastim biosimilar, in the European Union (EU). This approval, given to CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma, marks a key step in expanding the company’s biosimilar portfolio in Europe. The announcement came on April 05, 2025, reinforcing Aurobindo’s growing presence in the global pharmaceutical market.
Dyrupeg™, designed to support patients undergoing treatments that impact white blood cell counts, received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January 2025. This endorsement paved the way for the EC’s final approval, highlighting the biosimilar’s efficacy and safety.
In the exchange filing, Aurobindo Pharma shared, “The European Commission (EC) granted marketing authorization in the European Union (EU) for Dyrupeg™, a pegylated filgrastim biosimilar, to CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of the Company. Earlier in January 2025, the Committee for Medicinal Products (CHMP) of European Medicines Agency had adopted positive opinion recommending the approval of Dyrupeg™”
The authorization allows CuraTeQ Biologics to market Dyrupeg™ across EU countries, offering a cost-effective alternative to existing therapies. This development aligns with Aurobindo Pharma’s commitment to delivering high-quality, affordable healthcare solutions worldwide.
