Cipla and Qilu Partner to Develop Biosimilar of Keytruda

Cipla Limited, a global pharmaceutical company, has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. to develop, register, and supply a biosimilar to Keytruda (pembrolizumab) in the United States. The collaboration is part of Cipla's strategy to expand its oncology-focused portfolio and improve access to advanced biologic therapies.

Under the agreement, Qilu will handle the development and regulatory registration of QL2107, the biosimilar, while Cipla USA Inc. will be responsible for commercializing the product in the defined territory. The partnership marks a significant step in Cipla's efforts to leverage its strong commercial presence and Qilu's robust development capabilities to bring high-quality, affordable biologics to the market.

Achin Gupta, Managing Director and Global CEO of Cipla, stated, "This partnership underscores Cipla's commitment to biosimilars and our strategy to build a comprehensive oncology portfolio. By combining Qilu's strengths in R&D with Cipla's commercial expertise, we aim to enhance patient access to essential biologics."

Marc Falkin, CEO of Cipla North America, added, "We are excited to partner with Qilu to expand our biosimilar portfolio. Our collaboration is in line with our strategic vision to offer high-quality, cost-effective treatments to patients in the United States."

Hanchang Zhang, General Manager of Qilu Pharmaceutical, commented, "We are pleased to collaborate with Cipla on QL2107. Leveraging our combined resources, we are committed to delivering a high-quality, affordable pembrolizumab biosimilar to U.S. patients."

Cipla, founded in 1935, is a global pharmaceutical leader with a strong presence in India, South Africa, and North America. The company has 48 manufacturing sites worldwide, producing over 1,500 products using cutting-edge technology platforms. Cipla is ranked among the top pharmaceutical companies in India and South Africa and is focused on delivering affordable and accessible healthcare solutions.

Qilu Pharmaceutical, established in 1958, is one of China's leading vertically integrated pharmaceutical companies, specializing in the development, manufacture, and distribution of both finished dosage forms and active pharmaceutical ingredients. Qilu has secured 58 ANDA approvals from the U.S. FDA and exports its products to over 110 countries and regions worldwide.