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.”
Read also: Aurobindo Pharma arm CuraTeQ Biologics gets UK MHRA nod for cancer treatment Bevqolva
Aurobindo Pharma’s Vice Chairman and Managing Director Mr. K. Nithyananda Reddy said, “The positive
opinion received from CHMP for Dyrupeg furthers our commitment in developing high quality biosimilars and
driving access to patients suffering from illnesses such as cancer. CuraTeQ has a broad pipeline of biosimilars
across oncology and immunology segments and we are enthusiastic about the prospect of adding these over
time to Aurobindo’s commercial portfolio in global markets.”
