PRESTIGE BIOPHARMA
PRESTIGE BIOPHARMA IDC
PRESTIGE BIOLOGICS
Beyond technological discovery, expanding access to care for patients around the world
Innovative Drug
Development of First-in-Class therapeutics for unmet diseases
Biosimilar
Prominent Biosimilars pipelines for accelerating market access
Platform Technology
A drug delivery platform that enhances treatment convenience
Diagnostics
Diagnostics for Pancreatic cancer by detecting PAUF
Prestige Biopharma Submits EMA Marketing Authorization Application for Herceptin Biosimilar HD201
Prestige Biopharma Submits EMA Marketing Authorization Application
for Herceptin Biosimilar HD201
“Accelerating Commercialization for Entry into the European Biosimilar Market”
Prestige Biopharma, a biopharmaceutical company specializing in antibody therapeutics, announced on the 31st through a regulatory filing that it has completed the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its Herceptin biosimilar, HD201.
Following a pre-submission meeting with the EMA held in May, which concluded without major issues, the company proceeded with the final application and plans to accelerate commercialization efforts for its first entry into the European biosimilar market.
Prestige Biopharma has previously disclosed multiple sets of clinical data and analytical reports for HD201. In a global Phase 3 clinical trial conducted across 12 countries involving 502 patients with HER2-positive breast cancer, the biosimilar demonstrated comparable efficacy, pharmacokinetics, and safety to the reference product. In addition, the final Phase 3 analysis was published in the internationally recognized oncology journal BMC Cancer in January, further confirming long-term survival outcomes, safety, and equivalence between HD201 and the reference drug Herceptin.
The company has also secured a full value chain manufacturing system, enabling end-to-end production at its affiliate Prestige Biologics’ facility with a capacity of 154,000 liters. Process development has also been carried out to enhance production efficiency.
Soyeon Park, Chairperson of Prestige Biopharma, stated, “We have secured EU-GMP certification for our manufacturing facilities and have made every effort to address the issues raised during the previous review. We expect the evaluation to proceed in accordance with the EMA’s official review timeline.”
Reference: PharmNews (https://www.pharmnews.com/news/articleView.html?idxno=228150)
Read Prestige news >>
