Invagen Pharmaceuticals Inc, a wholly owned subsidiary of Cipla Limited, has entered into a strategic partnership with Qilu Pharmaceutical for the exclusive licensing and supply of QL2107, a biosimilar to Keytruda® (pembrolizumab), in the United States. The agreement strengthens Cipla’s focus on expanding its biosimilar portfolio and building a broader presence in oncology.
Under the terms of the partnership, Qilu Pharmaceutical will be responsible for the development, regulatory registration and supply of QL2107, while Cipla USA Inc. will lead commercialisation of the product in the United States, subject to applicable regulatory approvals. The collaboration combines Qilu’s capabilities in biosimilar development and manufacturing with Cipla’s established commercial infrastructure and market expertise in the US.
The partnership is aimed at supporting broader access to advanced biologic therapies while addressing the increasing healthcare burden associated with cancer. Pembrolizumab is an important biologic therapy used across a range of cancer indications, and the introduction of a biosimilar, subject to regulatory approval, has the potential to contribute to greater treatment accessibility and affordability for patients.
Achin Gupta, Managing Director and Global Chief Executive Officer, Cipla, said the agreement reflects the company’s confidence in the long-term potential of biosimilars and its strategy to build a stronger oncology-focused portfolio. He added that combining Qilu’s development capabilities with Cipla’s commercial reach and patient-focused approach would support the company’s objective of improving access to high-quality biologic therapies.
Marc Falkin, Chief Executive Officer, Cipla North America, said the collaboration is aligned with Cipla’s plans to expand its biosimilar portfolio over the coming fiscal years. He added that the company’s established commercial capabilities in the US would position it to support the launch of QL2107, subject to regulatory approval, and potentially help reduce treatment costs for patients.
Hanchang Zhang, General Manager, Qilu Pharmaceutical, said the company was pleased to establish the partnership with Cipla and highlighted Qilu’s growing biosimilar pipeline. He said the combination of Qilu’s research, development and manufacturing capabilities with Cipla’s US commercial expertise could support the delivery of a high-quality and affordable pembrolizumab biosimilar to American patients.
Founded in 1935, Cipla is a global pharmaceutical company focused on complex generics, sustainable growth and strengthening its presence across key markets. The company has established capabilities across respiratory, antiretroviral, urology, cardiology, anti-infective and central nervous system therapies. With 48 manufacturing sites producing more than 50 dosage forms and over 1,500 products, Cipla serves customers across more than 70 markets worldwide.
