Singapore, December 14, 2018 / B3C newswire / — Prestige BioPharma (“Prestige”) announced today that it has reached a licensing agreement with Cipla Limited (“Cipla”) for its trastuzumab biosimilar (HD201) under which Cipla will have exclusive rights to distribute and market the drug in selected emerging markets.

HD201 is a mAb biosimilar to Roche’s Herceptin® which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Prestige’s HD201 is in Phase 3 clinical development for filing with European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) in 2019.

This agreement will leverage Cipla’s strong local presence, sales and marketing capabilities in these markets. Prestige will be responsible for full development, product registration with EMA, and commercial supply of HD201 out of its manufacturing facilities in Osong, South Korea.

Lisa S. Park, Chief Executive Officer, Prestige, said: “We are very pleased to partner with Cipla to commercialize our lead biosimilar program in selected emerging markets. With this partnership, we made another important step towards a broad global availability of our Trastuzumab biosimilar product.”

Umang Vohra, Managing Director & Global Chief Executive Officer, Cipla, said: “Cipla has always stood for access to life-saving medicines, and through this partnership, we take this key drug to more countries and patients around the world. We will continue to focus on capitalising on our strengths to ensure high-quality medicines to patients in keeping with our purpose of ‘Caring for Life’.”