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Ujvin Nevatia

5th Sep · SEBI Registration INH100009628

Cipla Partners with Qilu for US Cancer Biosimilar

Research Analyst: UJVIN NEVATIA (PROPRIETOR: NEVAT INVESTMENTS) | SEBI Registration No.: INH100009628 Cipla (

CIPLA
), through its wholly owned subsidiary Invagen Pharmaceuticals Inc., has entered into an exclusive partnership with China-based Qilu Pharmaceutical for the licensing and supply of QL2107, a biosimilar to Keytruda (pembrolizumab), for the US market. Under the agreement, Qilu will be responsible for the product's development, regulatory registration and supply, while Cipla USA Inc. will handle its commercialisation in the United States. The product will require the necessary regulatory approvals before it can be launched. What Is a Biosimilar? A biosimilar is a biological medicine developed to be highly similar to an already approved reference biologic. Biosimilars are expected to meet regulatory standards for quality, safety and efficacy. Pembrolizumab is an immunotherapy used in the treatment of several cancers. Keytruda is the reference product for QL2107. Why Does the Partnership Matter? The agreement adds a potential oncology biosimilar to Cipla's US portfolio and aligns with the company's strategy to expand its presence in biosimilars and oncology. Cipla has previously identified biosimilars as an important long-term growth area. The partnership also divides responsibilities between the two companies: Qilu brings development and manufacturing capabilities, while Cipla will use its US commercial infrastructure to market the product if regulatory approval is obtained. The commercial contribution will depend on regulatory approvals, launch timing, market competition and product adoption. Source: The Hindu No Recommendations

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