Cipla Partners With Qilu Pharmaceutical to Commercialize a Keytruda Biosimilar in the US

InvaGen Pharmaceuticals, a wholly owned subsidiary of Cipla, entered into a strategic partnership with Qilu Pharmaceutical for the exclusive licensing and supply of QL2107, a biosimilar candidate to pembrolizumab (Keytruda), for the US.¹ Under the agreement, Qilu will be responsible for development, regulatory registration, and supply of the product, while Cipla USA will handle commercialization, leveraging its existing US commercial infrastructure.¹ Financial terms were not disclosed.²

Achin Gupta, managing director and global chief executive officer of Cipla, said, "This partnership reflects Cipla's confidence in the long-term potential of biosimilars and supports our strategy to build a strong oncology-focused portfolio. By combining Qilu's development strengths with Cipla's commercial presence and patient-centric legacy, we aim to expand access to high-quality biologics for patients across our focus markets."¹ Hanchang Zhang, general manager of Qilu Pharmaceutical, said, "Qilu boasts a robust and growing biosimilar product pipeline. By combining our R&D and manufacturing strengths with Cipla's U.S. commercial expertise, we aim to bring a high-quality, affordable pembrolizumab biosimilar to U.S. patients."¹ Cipla North America chief executive officer Marc Falkin framed the deal within the company's broader biosimilar strategy for the coming fiscal years.¹

What is QL2107, and how far along is it?

QL2107 is a monoclonal antibody biosimilar targeting PD-1, the immune checkpoint receptor targeted by Keytruda.² It is currently in phase 3 development, with a trial in metastatic non-squamous non-small cell lung cancer initiated in January 2025; no clinical data has been disclosed publicly to date.² Pembrolizumab itself is a humanized IgG4 monoclonal antibody that binds with high affinity to the PD-1 receptor on T cells, blocking its interaction with the ligands PD-L1 and PD-L2 and thereby reactivating T-cell–mediated antitumor immune responses.³ The next meaningful milestone for the program is completion of phase 3 enrollment and a subsequent data readout, which would support a US biologics license application filing.²

Why does the timing of this deal matter?

Keytruda is scheduled to lose its US patent protection in 2028, making it one of several blockbuster biologics approaching a steep patent cliff that industry analysts expect to reshape competitive dynamics across oncology.⁴ BioPharm International has reported that a coming wave of oncology biosimilar launches is widely anticipated to include Keytruda and Opdivo, following a similar wave roughly five to seven years ago for rituximab, trastuzumab, and bevacizumab. "Looking to the future, we will see another wave of significant oncology biosimilar launches like we did about five to seven years ago with rituximab, trastuzumab, and bevacizumab. This next wave will include blockbusters such as Keytruda (pembrolizumab) and Opdivo (ipilimumab)," said Thomas Nusbickel, chief commercial officer, Celltrion USA, in earlier BioPharm International coverage unrelated to this specific deal.⁵

Cipla and Qilu are not the only companies positioning for this transition. Alvotech and Dr. Reddy's Laboratories announced a collaboration in June 2025 to co-develop a Keytruda biosimilar for global markets,⁶ and Formycon and Zydus Lifesciences separately partnered in December 2025 on FYB206, another Keytruda biosimilar candidate for the US and Canada, with primary endpoint data expected in early 2026.⁷

What happens next?

QL2107's phase 3 enrollment and data readout will determine the timeline for a US biologics license application filing; commercialization by Cipla remains subject to regulatory approval.¹

References

1. Cipla Announces Exclusive Partnership with Qilu Pharmaceutical for the Licensing and Supply of Biosimilar to Keytruda® (Pembrolizumab) in the US. BioSpace. Published September 3, 2026. Accessed September 4, 2026.
2. Cipla joins Keytruda biosimilar race with Qilu deal. AllSci. Published September 4, 2026. Accessed September 4, 2026.
3. McDermott J, Jimeno A. Pembrolizumab: PD-1 inhibition as a therapeutic strategy in cancer. Drugs Today (Barc). 2015;51(1):7-20. doi:10.1358/dot.2015.51.1.2250387.
4. Facing the Latest Patent Cliff. BioPharm International. Published April 1, 2025. Accessed September 4, 2026.
5. The Challenge of Market Uptake for Biosimilars. BioPharm International. Published May 7, 2025. Accessed September 4, 2026.
6. Alvotech. Alvotech and Dr. Reddy's Enter into Collaboration to Co-Develop Biosimilar Candidate to Keytruda® (pembrolizumab). Press release. Published June 5, 2025. Accessed September 4, 2026.
7. Formycon AG. Formycon and Zydus Partner for Exclusive Licensing and Supply Agreement of FYB206, a Biosimilar to Keytruda® (Pembrolizumab), in the U.S. and Canada. Press release. Published December 9, 2025. Accessed September 4, 2026.