- Gedeon Richter and Hetero have signed a global collaboration agreement for the joint development, registration, and commercialization of Semaglutide Injection, a generic version of Ozempic®.
- Regulatory filings are underway, with submissions planned in the European Union and the United States in 2027.
Gedeon Richter Plc. and Hetero Labs Ltd. have entered into a global collaboration agreement for the joint development, registration, and commercialization of Semaglutide Injection, a generic version of Ozempic®. The partnership expands the companies’ existing relationship and is intended to support broader patient access to treatments for diabetes and related cardiometabolic conditions.
Under the agreement, the companies will operate through a joint governance structure with defined territorial responsibilities and a cost- and profit-sharing model. Hetero has already invested in technology setup and registration batch manufacturing, and regulatory activities are progressing. The companies stated that submissions in the European Union and United States are planned for 2027.
The collaboration combines Hetero’s commercial presence in the United States and emerging markets with Richter’s established infrastructure across Europe and Central Asia. The agreement also preserves the option for future European manufacturing by Richter.
“This collaboration reflects the strong alignment, commitment, and shared pursuit of excellence between Hetero and Richter, forming a powerful partnership. It will enable us to deliver high-quality, affordable therapies to patients living with diabetes and related cardiometabolic conditions worldwide.”
Dr. Bence Kovács, Global Head of General Medicines at Richter
The companies said the collaboration is designed to support the global development and commercialization of Semaglutide Injection while leveraging their respective development, manufacturing, and commercial capabilities. The agreement further strengthens their long-term partnership in the growing market for diabetes and cardiometabolic therapies.
