Aurobindo Pharma arm gets positive opinion for biosimilar Dyrupeg from EMA

Hyderabad: CuraTeQ Biologics s.r.o., a step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion for Dyrupeg (BP14, a pegylated filgrastim biosimilar) recommending the granting of a marketing authorisation.    

The CHMP positive opinion is expected to translate into a formal decision of approval by the European Commission in April 2025.

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Commenting on the update, Dr Satakarni Makkapati, Director Aurobindo Pharma and CEO Biologics, Vaccines and Peptides said, "After receiving the GMP certificate of compliance from the EMA in November, the positive opinion of Dyrupeg from CHMP follows the marketing approval of Bevqolva (a bevacizumab biosimilar) by UK’s MHRA in December 2024, and CHMP’s positive opinion of Zefylti (a filgrastim biosimilar) in December 2024. The CHMP positive opinion of Dyrupeg is based upon a review of evidence of analytical biosimilarity, demonstrating equivalence and no clinically meaningful differences in pharmacokinetics, pharmacodynamics, and immunogenicity to the EU-registered reference product Neulasta. We intend to bring these treatment options to patients in Europe in the second half of 2025 and are on course to file in additional markets for approval."