Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, has entered into a strategic partnership with Qilu Pharmaceutical for the exclusive licensing and supply of QL2107, a biosimilar of Merck’s Keytruda (pembrolizumab), in the United States.
Keytruda is approved to treat certain types of early-stage and advanced cancers.
Under the agreement, Qilu will be responsible for the development, regulatory registration and supply of the product, while Cipla USA will oversee its commercialisation in the US.
The companies said the collaboration reflects their shared commitment to addressing the growing burden of cancer and improving access to advanced biologic therapies.
“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,” said Achin Gupta, managing director and global CEO of Cipla.
Marc Falkin, CEO, Cipla North America, said the collaboration aligns with the company’s strategy to expand its biosimilar portfolio in the coming fiscal years.
“With our established commercial capabilities, we are well-positioned to successfully launch QL2107, subject to regulatory approval, and help ensure it reaches patients in need while lowering the cost of treatment,” he added.
Hanchang Zhang, general manager of Qilu Pharmaceutical, said the partnership combines the company’s R&D and manufacturing strengths with Cipla’s commercial expertise in the US to bring a high-quality, affordable pembrolizumab biosimilar to US patients.
Keytruda is FDA-approved for the treatment of early-stage non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma (HNSCC), urothelial cancer, colon or rectal cancer, gastric or gastroesophageal junction (GEJ) adenocarcinoma, oesophageal or certain gastroesophageal junction (GEJ) carcinomas, cervical cancer, ovarian cancer, triple-negative breast cancer (TNBC), cutaneous squamous cell carcinoma (cSCC), advanced endometrial carcinoma, and renal cell carcinoma (RCC).
In July, the US FDA approved Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma), as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle-invasive bladder cancer (MIBC).
This approval expands the prior indication for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.
