Aurobindo Pharma's Subsidiary Curateq Biologics Secures Positive EMA Opinion for Biosimilar Dyrupeg

Aurobindo Pharma Limited has announced a significant milestone for its subsidiary, Curateq Biologics. The European Medicines Agency (EMA) has issued a positive opinion for Dyrupeg, a biosimilar pegfilgrastim developed by Curateq. This recommendation paves the way for potential approval by the European Commission, expected in April 2025.Key points:

1. Curateq Biologics, a subsidiary of Aurobindo Pharma, received a positive opinion from EMA for biosimilar Dyrupeg.
2. Dyrupeg is a biosimilar to Neulasta® (pegfilgrastim), used to reduce the duration of neutropenia and incidence of febrile neutropenia in cancer patients.
3. European Commission approval is anticipated in April 2025.
4. This marks Aurobindo's entry into the European biosimilars market, a high-growth segment in the pharmaceutical industry.
5. The development aligns with Aurobindo's strategy to expand its presence in complex generics and biosimilars.

This positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) is based on a comprehensive package of analytical, non-clinical, and clinical data demonstrating Dyrupeg's similarity to the reference product in terms of quality, safety, and efficacy.Aurobindo Pharma's Managing Director stated, "This positive opinion for Dyrupeg is a significant milestone in our biosimilars journey. It reflects our commitment to bringing high-quality, affordable biologics to patients worldwide."The potential approval and launch of Dyrupeg in Europe would mark Aurobindo's entry into the lucrative European biosimilars market, estimated to reach $13.8 billion by 2027. This move is expected to contribute significantly to the company's revenue growth and diversification strategy.

Source: Based on Aurobindo Pharma's regulatory filings and company announcements