Pune-based biologics maker Enzene has handed the global rights to its romiplostim biosimilar programme to Adalvo, a Switzerland-headquartered B2B pharmaceutical company, in a deal that also marks Enzene’s shift to a business model built entirely around contract development and manufacturing. Enzene will continue to develop and manufacture the product from its GMP-approved facilities in Pune, India. Financial terms were not disclosed.

What Adalvo is buying

The programme references Amgen’s Nplate (romiplostim), a thrombopoietin receptor agonist given as a weekly injection to treat adult and chronic paediatric immune thrombocytopenia (ITP), a largely autoimmune disorder marked by low platelet counts. According to the companies, the reference product generated roughly USD 1.5 billion in global sales in 2025.

Enzene’s biosimilar is produced using microbial cell line technology. The company has already taken it from cell line development through regulatory approval and commercial supply in India; BioPharm International notes that Enzene received Indian marketing authorisation for romiplostim in August 2021.

For Adalvo, which has so far focused on specialty generics, peptides and brands, the acquisition is a step into complex biologics. The company says it works with more than 170 pharmaceutical partners across over 140 countries and is building a wider biosimilars portfolio that runs from cell line development to commercialisation.

“Biosimilars are a natural extension of Adalvo’s capabilities into complex biological medicines and an important part of our long-term growth strategy,” said Anil Okay, CEO of Adalvo, adding that the company hopes the relationship with Enzene will extend beyond a single programme.

Enzene’s pivot to a pure-play biologics CDMO

For Enzene, the deal is described as a strategic inflection point. Having built an integrated biosimilar platform covering cell line development, process development, clinical supply and commercial manufacturing, the company is now moving its biosimilar pipeline to commercial partners and concentrating fully on contract development and manufacturing services for biologics.

Under the agreement, Enzene will remain Adalvo’s development and manufacturing partner for romiplostim, including support for regulatory filings with the US FDA, the European Medicines Agency and other international regulators.

“Having taken romiplostim from cell line development through to regulatory approval and commercial supply in India, we are entrusting a strong global partner to bring it to patients internationally, while Enzene continues as development and manufacturing partner,” said Dr Himanshu Gadgil, CEO of Enzene. He said the transaction strengthens Enzene’s position as a global biosimilar CDMO.

Enzene operates facilities in India and the US and runs its EnzeneX fully connected continuous manufacturing platform for biologics, which it says is validated for commercial production.

Why it matters for Indian pharma

The transaction reflects a model gaining ground across Indian biopharma: domestic companies that have done the hard science and regulatory work on complex biosimilars are partnering with global commercial players for international markets, while keeping the manufacturing in India. For the country’s biologics CDMO sector, an Indian-developed, Indian-approved biosimilar heading towards US and European filings from a Pune plant is a useful signal of the capability that global partners are now buying into.

Sources: Enzene and Adalvo press release (27 October 2026); BioPharm International; Contract Pharma.

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