Adalvo Acquires Romiplostim Biosimilar Program From Enzene

COMPANY PROFILE
  • Adalvo has acquired a romiplostim biosimilar program from Enzene, expanding its portfolio of complex biological medicines and supporting its global biosimilars strategy.
  • Enzene will continue as the program’s development and manufacturing partner, supplying the product from its GMP-approved facilities in Pune, India, and supporting regulatory filings with international authorities.

Adalvo has acquired a romiplostim biosimilar program referencing Nplate® from Enzene, expanding its portfolio of complex biological medicines. The transaction supports Adalvo’s strategy to build a broader biosimilars business and bring additional biological medicines to international markets.

The acquired program references Nplate® (romiplostim), a treatment indicated for adults and children with chronic immune thrombocytopenia (ITP). Developed using microbial cell line technology, the program adds a technically complex asset to Adalvo’s portfolio. The reference product generated approximately $1.5 billion in global sales in 2025, according to the announcement.

Under the agreement, Enzene will remain the development and manufacturing partner for the romiplostim program. The company will support regulatory filings with the U.S. Food and Drug Administration, the European Medicines Agency, and other international regulatory authorities. Product supply will come from Enzene’s GMP-approved facilities in Pune, India.

The transaction builds on Enzene’s work taking the romiplostim program from cell line development through regulatory approval and commercial supply in India. Enzene said it will focus its business model on contract development and manufacturing services for biologics while continuing to develop, scale, and manufacture complex biological medicines for global partners.

“Biosimilars are a natural extension of Adalvo’s capabilities into complex biological medicines and an important part of our long-term growth strategy. The acquisition combines Enzene’s scientific and manufacturing expertise with Adalvo’s global development, regulatory, and commercial platform, and could support a longer-term strategic relationship between the companies.”

Anil Okay, CEO of Adalvo
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