New Launch5 Apr 2025, 08:01 pm
Aurobindo Pharma Subsidiary Receives Marketing Authorisation for Pegylated Filgrastim Biosimilar in EU
AI Summary
Aurobindo Pharma Ltd. has announced that its wholly owned step-down subsidiary, CuraTeQ Biologics s.r.o, has received marketing authorisation from the European Commission (EC) for Dyrupeg™, a pegylated filgrastim biosimilar. This authorisation comes after the Committee for Medicinal Products (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of Dyrupeg™ in January 2025.
Key Highlights
- Aurobindo Pharma's subsidiary, CuraTeQ Biologics s.r.o, received marketing authorisation from the European Commission for Dyrupeg™, a pegylated filgrastim biosimilar.
- The marketing authorisation follows a positive opinion from the Committee for Medicinal Products of the European Medicines Agency in January 2025.
- Dyrupeg™ is a biosimilar to pegylated filgrastim, a form of granulocyte colony-stimulating factor (G-CSF)
- This development marks a significant step for Aurobindo Pharma in the European biologics market.
- The company is expected to commence commercialisation of Dyrupeg™ in the EU market soon.