Curateq Clinches UK MHRA Nod—Dyrupeg Gets Injected into Approval List

Aurobindo Pharma's biologics subsidiary, Curateq Biologics, has won a significant regulatory nod from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its biosimilar Dyrupeg—a pegylated filgrastim indicated to reduce the incidence of neutropenia in patients undergoing chemotherapy for cancer.

 

Dyrupeg, BP14, is a biosimilar to Neulasta™, and will be available as a 6 mg concentration in prefilled syringes. The approval follows thorough review of analytical, pharmacokinetic, and immunogenicity data confirming its similarity to the reference product.

 

This MHRA clearance is adding to Curateq's accelerating momentum in the biosimilars division, following earlier favorable opinions from the European Medicines Agency's CHMP. Curateq will market Dyrupeg in the UK in the second half of 2025 and pursue other global markets filings.

 

Aurobindo's leadership emphasized that this milestone underscores their commitment to expanding access to high-quality, affordable biologics to oncology patients worldwide.

 

Relevant Sources: Curateq Biologics, Indian Pharma Post, Aurobindo Pharma