Cipla, Qilu Enter Licensing and Supply Deal for Keytruda Biosimilar in US

Editor’s Take: Access to advanced biologic therapies is expanding as more biosimilars for more conditions come on the market.

Cipla and Qilu Pharmaceutical have an agreement for exclusive licensing and supply of QL2107, a biosimilar to Keytruda (pembrolizumab).

This new strategic partnership between Invagen Pharmaceuticals—a Cipla subsidiary—and Qilu applies in the United States. Keytruda is a cancer drug, manufactured by Merck (known as MSD outside the U.S. and Canada).

Cipla and Qilu Responsibilities

The agreement breaks down in the following way. Qilu assumes responsibility for development, regulatory registration, and supply of QL2107. Subsequently, Cipla USA takes ownership of commercialization. Cipla intends to do this by leveraging its strong U.S. commercial presence.

Both companies say they share a commitment to addressing the “growing burden of cancer.”

Not only that, but Cipla and Qilu also aspire to improve access to advanced biologic therapies.

Growing Need for Biosimilars

“This partnership reflects Cipla’s confidence in the long-term potential of biosimilars,” Cipla Managing Director and Global CEO Achin Gupta said. “[It] 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.”

Cipla North America CEO Marc Falkin mentioned a dual purpose: ensuring QL2107 reaches patients in need while lower treatment costs.

“This collaboration aligns with our strategy to expand our biosimilar portfolio in the coming fiscal years,” Falkin said. “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.”

“We are pleased to establish this partnership with Cipla for QL2107,” Qilu General Manager Hanchang Zhang said. “Qilu boasts a robust and growing biosimilar product pipeline. We aim to bring a high-quality, affordable pembrolizumab biosimilar to U.S. patients.”