Cipla Limited announced that its wholly owned subsidiary, Invagen Pharmaceuticals Inc, has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. for the exclusive licensing and supply of QL2107, a biosimilar to Keytruda® (pembrolizumab), for the United States market.

Partnership Structure and Responsibilities

Under the terms of the agreement:

  • Qilu Pharmaceutical will be responsible for the development, regulatory registration, and supply of the product QL2107.
  • Cipla USA Inc. will be responsible for the commercialization of the asset in the defined territory (United States), leveraging its strong commercial presence.

Strategic Commentary

Achin Gupta, Managing Director & Global Chief Executive Officer, Cipla, stated that the partnership reflects Cipla's confidence in the long-term potential of biosimilars and supports its strategy to build a strong oncology-focused portfolio. The aim is to combine Qilu's development strengths with Cipla's commercial presence and patient-centric legacy to expand access to high-quality biologics.

Marc Falkin, Chief Executive Officer, Cipla North America, stated that the collaboration is aligned with the strategy to expand the biosimilar portfolio in the coming fiscal years. With established commercial capabilities, Cipla is positioned to successfully launch QL2107, subject to regulatory approval, to help ensure it reaches patients while lowering the cost of treatment.

Hanchang Zhang, General Manager of Qilu Pharmaceutical, stated that Qilu boasts a robust and growing biosimilar product pipeline. By combining its R&D and manufacturing strengths with Cipla's U.S. commercial expertise, the aim is to bring a high-quality, affordable pembrolizumab biosimilar to U.S. patients.

About Cipla Limited (Corporate Background)

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening its portfolio in home markets of India, South Africa, North America, and key regulated and emerging markets. Key strengths are in respiratory, antiretroviral, urology, cardiology, anti-infective, and CNS segments.

  • 48 manufacturing sites worldwide producing 50+ dosage forms and 1,500+ products for 70+ markets.
  • Market Rankings: 3rd largest in pharma in India (IQVIA MAT Jun'26), 2nd Largest in the pharma prescription market in South Africa (IQVIA MAT May'26), and 2nd largest by prescription in the US Gx (Repulses + MDI) products (IQVIA MAT Jun'26).

About Qilu Pharmaceutical (Partner Background)

Established in 1958, Qilu Pharmaceutical is a leading vertically integrated pharmaceutical company in China that develops, manufactures, and distributes both Finished Dosage Forms (FDFs) and Active Pharmaceutical Ingredients (APIs).

  • 11 domestic manufacturing sites and employs more than 38,000 people worldwide.
  • Ranked among the Top 3 enterprises in China's pharmaceutical industry in 2025.
  • Exports products to over 110 countries and regions.
  • Regulatory Approvals: 58 ANDA approvals from the U.S. FDA, with 28 formulations launched in the EU and the United Kingdom.
  • Pipeline: Over 50 biosimilars, 130-plus innovative drugs, and more than 200 generic drug candidates in-development.