Dyrupeg (pegfilgrastim biosimilar) / Aurobindo, CuraTeQ Biologics - LARVOL DELTA

Aurobindo Pharma's subsidiary, CuraTeQ Biologics, has received a Notice of Compliance from Health Canada for its biosimilar Dyrupeg (Devdiscourse) - "This drug is designed for cancer patients experiencing low neutrophil levels, a critical component of the immune system. The Notice of Compliance granted by the Biologics and Radiopharmaceutical Drugs Directorate marks a pivotal approval for Dyrupeg, a pegylated filgrastim biosimilar."

Canada approval • Neutropenia • Oncology

Aurobindo Pharma’s CuraTeQ secures UK’s MHRA approval for Dyrupeg (Business Upturn) - "CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma Ltd, has received marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Dyrupeg, a biosimilar of pegylated filgrastim."

MHRA approval • Neutropenia • Oncology

Aurobindo Pharma's arm receives permission from European Commission to market Dyrupeg (Business Standard) - "Aurobindo Pharma announced that its wholly owned step-down subsidiary, CuraTeQ Biologics s.r.o., has received permission from the European Commission (EC) to market Dyrupeg in the European Union....Dyrupeg is a biosimilar medicine containing the active substance pegfilgrastim, intended to reduce the duration of neutropenia and prevent febrile neutropenia in adult cancer patients treated with cytotoxic chemotherapy."

EMA approval • Neutropenia • Oncology

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025 (European Medicines Agency) - "On 30 January 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dyrupeg, intended to shorten the duration of neutropenia and help prevent febrile neutropenia after cytotoxic chemotherapy. The applicant for this medicinal product is CuraTeQ Biologics s.r.o. Dyrupeg will be available as a 6 mg solution for injection in pre-filled syringe. The active substance of Dyrupeg is pegfilgrastim, an immunostimulant, colony-stimulating factor (ATC code: L03AA13), which stimulates the development and differentiation of mature and functionally active neutrophils from precursor cells in the bone marrow."

CHMP • Chemotherapy-Induced Neutropenia

Aurobindo Pharma’s subsidiary seeks marketing approval of its first biosimilar product from EMA (Moneycontrol) - “Aurobindo Pharma, on September 23, announced that its subsidiary has submitted an application to the European Medicines Agency (EMA) seeking marketing approval of its Pegfilgrastim biosimilar…‘We remain on track for filing our second product, another oncology biosimilar in the regulated markets, in this calendar year’…‘Another biosimilar from our oncology portfolio, currently in Phase 3 clinical studies, has reached the 50 percent patient recruitment milestone this month and we hope to complete the recruitment in the next two quarters…’’’

Enrollment status • European regulatory • Oncology