CuraTeQ Biologics, a wholly owned step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys® (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers.

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on certain types of solid cancers such as breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its ability to signal, leading to cell cycle arrest, reduced tumor growth, and potentially immune system activation to destroy cancer cells.

Commenting on the update, Dr. Satakarni Makkapati, Director of Aurobindo Pharma and CEO Biologics, Vaccines, and Peptides stated “The CHMP’s positive opinion is based on demonstrating comprehensive analytical similarity and clinically no meaningful differences between Dazublys® and the reference biologic product Herceptin in terms of pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, and immunogenicity. Upon European Commission approval that is expected in July, Dazublys® will be available for use across EU member states. This marks our third biosimilar to receive CHMP’s endorsement and the fourth overall in the EU, alongside the approval of Bevqolva® (a bevacizumab biosimilar) by the MHRA in November 2024. Biosimilars are playing an important role in improving cancer care, and we remain committed to expanding our biosimilars portfolio to address the unmet needs of patients.”

Aurobindo Pharma’s Vice Chairman and Managing Director Mr. Nithyananda Reddy said, “The CHMP’s positive opinion of a third biosimilar from our portfolio in a five-month time period underscores our extensive efforts inbuilding biosimilars as one of the core businesses at Aurobindo. By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments, furthering our mission to serve patients with high-quality, cost-effective therapies.”

About CuraTeQ: CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. The company is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.

Article excerpt reposted from: Medical Dialogues

Aurobindo Pharma Ltd. on Friday (December 13) announced that its wholly-owned subsidiary, CuraTeQ Biologics Private Ltd, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Zefylti (BP13), a Filgrastim biosimilar.

“…the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion for Zefylti (BP13, a filgrastim biosimilar) recommending the granting of a marketing authorisation to CuraTeQ Biologics Private Limited, a wholly-owned subsidiary of the company,” Aurobindo Pharma said in a regulatory filing.

The CHMP recommendation is a critical step towards obtaining marketing authorisation for Zefylti in the European Union. Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs).

Aurobindo Pharma spokesperson said, “After receiving the GMP certificate of compliance from the European Medicines Agency (EMA) in November, Zefylti is our first biosimilar to receive a positive opinion from EMA’s CHMP. Two more products, our biosimilar versions of pegylated filgrastim (BP14) and trastuzumab (BP02), are currently under review with the EMA, and a biosimilar to bevacizumab (BP01) is under review with the MHRA. We are confident and on track to bring these treatment options to patients next year.”

Article excerpt reposted from CNBCTV18.