Zydus Lifesciences, Synthon ink pact for new oncology product

This 505(B)(2) Oncology product will likely be filed in 2026 and will be offering additional strengths that is intended to provide reduced pill burden, flexibility for dose adjustment and enhanced patient compliance.

Speaking on the development, Managing Director of Zydus Lifesciences Ltd., Dr. Sharvil Patel said, “We are pleased to partner with Synthon for the commercialization of this complex drug product in the US market. The partnership will bring access to a high unmet need therapy area. We are certain that by pooling our resources and knowledge, we will meet critical needs of patients and stakeholders.”

Anish Mehta, CEO of Synthon BV, stated, “This 505(B)(2) product is another example of Synthon’s superior complex product development capabilities and represents a strategic move toward more complex and clinically differentiated products. We are excited to strengthen our partnership with Zydus, who will bring this critical medicine to market to provide patients with important treatment alternatives for this extremely challenging condition.”

The addressable market size of Reference Product is approximately US$1.5 billion as per IQVIA MAT Dec 2024.

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. 

Read also: Zydus Usnoflast gets USFDA Orphan Drug Designation for amyotrophic lateral sclerosis