Cipla Limited has announced an exclusive partnership with Qilu Pharmaceutical for the licensing and supply of QL2107, a biosimilar to Keytruda® (pembrolizumab), in the United States. Under the agreement, Qilu will manage development, regulatory registration, and supply, while Cipla USA will handle commercialization. This collaboration aims to enhance access to high-quality, affordable oncology biologics for US patients.
Cipla and Qilu Pharmaceutical Forge US Biosimilar Alliance
Cipla Limited, through its subsidiary Invagen Pharmaceuticals Inc., has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. This collaboration focuses on the exclusive licensing and supply of QL2107, a biosimilar candidate for Keytruda® (pembrolizumab), within the United States market. The announcement was made on September 3, 2026.
Roles and Responsibilities
Under the terms of the agreement, Qilu Pharmaceutical will be responsible for the comprehensive development, regulatory registration, and manufacturing of the product. Cipla USA Inc. will leverage its established commercial infrastructure and market presence to lead the commercialization efforts for QL2107 in the United States. This division of roles aims to optimize the go-to-market strategy and ensure efficient product delivery.
Strategic Implications and Company Statements
This partnership underscores Cipla’s commitment to expanding its biosimilar portfolio, particularly in the oncology segment, and aligns with its strategy to build a robust oncology-focused pipeline. Achin Gupta, Managing Director & Global Chief Executive Officer of Cipla, stated, “This partnership reflects Cipla’s confidence in the long-term potential of biosimilars and supports our strategy to build a strong oncology-focused portfolio.” Marc Falkin, Chief Executive Officer, Cipla North America, added, “We are excited to add QL2107 with Qilu who have been great partners. With our established commercial capabilities, we are well-positioned to successfully launch QL2107, subject to regulatory approval, and help ensure it reaches patients in need while lowering the cost of treatment.” Hanchang Zhang, General Manager of Qilu Pharmaceutical, expressed enthusiasm for the collaboration, highlighting Qilu’s robust R&D and manufacturing strengths.
About the Companies
Cipla Limited, established in 1935, is a global pharmaceutical company with a focus on agile and sustainable growth, complex generics, and expanding its portfolio across India, South Africa, North America, and other key markets. It has a strong presence in respiratory, antiretroviral, urology, cardiology, anti-infective, and CNS segments.
Qilu Pharmaceutical, founded in 1958, is a leading vertically integrated pharmaceutical company in China, involved in the development, manufacturing, and distribution of Finished Dosage Forms (FDFs) and Active Pharmaceutical Ingredients (APIs). Qilu has a significant pipeline, including over 50 biosimilars.
Source: BSE
