Singapore-based company involved in biopharmaceuticals Prestige Biopharma announced on Thursday that it has received positive recommendation from the European Medicines Agency's (EMAs) Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation for Tuznue, a Herceptin (trastuzumab) biosimilar.

This step is claimed to position the company to become the first Singaporean firm to commercialise its biosimilar in the European Union. The positive opinion is based on clinical indication from Phase one and Phase three clinical studies that tested the bio-similarity of Tuznue to Herceptin.

The company has already entered into licensing agreements with major pharmaceutical partners for global marketing and sales.

Lisa Park, Prestige Biopharma CEO, said, 'Receiving a positive CHMP opinion for Tuznue marks a major milestone for Prestige Biopharma, significantly advancing our revenue generation strategy and accelerating future pipeline approvals. This recognition solidifies our position as a leading biosimilar developer. We are committed to leveraging this achievement to enhance our market presence and drive continued success.'