Adalvo Acquires Romiplostim Biosimilar Program to Expand Biologics Portfolio
Key Points
- Adalvo acquired a romiplostim biosimilar program from Enzene, referencing Nplate for immune thrombocytopenia (ITP) in adults and children.
- The reference product generated approximately $1.5 billion in global sales in 2025, supporting the commercial opportunity.
- Enzene will continue development and manufacturing at its GMP facilities in Pune, India, and support FDA and EMA submissions, while shifting focus to CDMO services.
Adalvo has acquired a romiplostim biosimilar program from Enzene, adding a complex biologic candidate to its growing portfolio and advancing its expansion into the global biosimilars market. The deal covers a biosimilar referencing Nplate® (romiplostim), a treatment for immune thrombocytopenia (ITP) in adults and children with chronic disease. The program was developed using microbial cell line technology, reflecting the technical expertise required to develop and manufacture complex biological medicines.
The opportunity is supported by the commercial performance of the reference product, which generated approximately $1.5 billion in global sales in 2025. Adalvo plans to use its international development, regulatory, supply, and commercial infrastructure to bring the biosimilar to markets beyond India, with the goal of expanding access to biological medicines.
According to Adalvo CEO Anil Okay, the acquisition represents a strategic extension of the company’s established capabilities in complex pharmaceuticals. He said the program combines Enzene’s scientific and manufacturing expertise with Adalvo’s global reach and forms part of a broader effort to build a biosimilars portfolio spanning development through commercialization.
Enzene will remain responsible for development and manufacturing activities associated with the program. The company has advanced romiplostim from cell line development through regulatory approval and commercial supply in India, and will support regulatory submissions to the FDA, the European Medicines Agency, and other international authorities. Manufacturing will take place at Enzene’s GMP-approved facilities in Pune, India.
For Enzene, the agreement also reflects a shift toward focusing its business on contract development and manufacturing services for biologics. CEO Himanshu Gadgil said the company intends to continue supporting Adalvo on romiplostim while expanding its CDMO services for biopharmaceutical partners worldwide.
The transaction fits into Adalvo’s broader strategy of growing its portfolio through acquisitions, licensing agreements, and targeted investments. By adding biosimilars to its established pharmaceutical capabilities, the company aims to strengthen its position in complex medicines and develop additional opportunities across international markets.
For more information, visit www.enzene.com.
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