Under terms of the agreement, Cipla will have exclusive rights to distribute and market Prestige’s trastuzumab biosimilar (HD201) in selected emerging markets.
Prestige Biopharma, a Singapore-based biopharmaceutical company, recently announced that it has entered into a licensing agreement with Cipla Limited. Under terms of the agreement, Cipla will have exclusive rights to distribute and market Prestige’s trastuzumab biosimilar (HD201) in selected emerging markets.
The biosimilar, referencing Roche’s Herceptin, is currently being investigated in a phase 3 study for the treatment of HER2-positive breast cancer and HER2-positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Prestige plans to submit the proposed biosimilar for regulatory approval with the European Medicines Agency and with the FDA in 2019.
“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,” said Lisa Park, CEO of Prestige, in a statement.
The agreement will focus on leveraging Cipla’s strong local presence as well as sales and marketing capabilities within the local markets. Through the agreement, Prestige will be responsible for the development, product registration, and commercial supply of the biosimilar, while Cipla will be responsible for the marketing and commercialization.
“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 capitalizing on our strengths to ensure high-quality medicines to patients in keeping with our purpose of ‘Caring for Life,’” said Umang Vohra, managing director and global CEO of Cipla.
Other products currently being developed in Prestige’s pipeline include HD204, a potential bevacizumab biosimilar currently undergoing phase 1 and 3 trials, and PBP1502, a potential adalimumab biosimilar currently in a phase 1 trial. Potential biosimilars in preclinical development include denosumab, aflibercept, eculizumab, and ipilimumab molecules.