Adalvo 收购 Enzene 罗米司亭生物类似药项目，Enzene 转向纯 CDMO 模式

Adalvo’s purchase of Enzene’s Nplate biosimilar program extends it into biologics and moves Enzene toward a CDMO-only model.

Adalvo has acquired a romiplostim biosimilar program from Enzene, extending the Swiss pharmaceutical company beyond specialty generics and peptides into biologics, the companies announced Oct. 27.¹ Enzene will remain the development and manufacturing partner, which moves the company further toward a contract-only business model.¹

“Biosimilars are a natural extension of Adalvo’s capabilities into complex biological medicines and an important part of our long-term growth strategy. This acquisition strengthens our portfolio with a technically sophisticated programme while bringing together Enzene’s scientific and manufacturing expertise with Adalvo’s global development, regulatory and commercial platform. We are proud to partner with Enzene, a highly respected organisation with deep scientific and manufacturing expertise, and we look forward to establishing a long-term strategic relationship that extends beyond a single programme,” said Anil Okay, CEO of Adalvo.¹

Key Facts

Drug: Romiplostim biosimilar referencing Nplate

Class: Thrombopoietin receptor agonist

Indication: Immune thrombocytopenia (ITP)

Action: Program acquisition; no terms disclosed

Status: Approved in India

Nplate 2025 sales: ~$1.5B (per release)

“This partnership with Adalvo is a milestone for Enzene. 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. This transaction strengthens Enzene’s position as a leading global biosimilar CDMO, developing, scaling and manufacturing complex biologics for partners worldwide. Enzene is built on deep scientific, regulatory and GMP expertise and a proven multi-market track record. We look forward to building on this relationship with Adalvo in the years ahead,” said Himanshu Gadgil, Ph.D., CEO of Enzene.¹

What does the deal change for Adalvo and Enzene?

Adalvo describes an end-to-end model that runs from portfolio selection through commercial out-licensing and says it works with more than 170 pharmaceutical companies in over 140 countries.¹ The company says it is assembling biosimilar assets across the value chain, from cell line development to commercialization.¹

Financial terms were not included in the announcement. For Enzene, the sale marks a transition of its biosimilar pipeline to commercial partners and a shift to a business focused entirely on contract development and manufacturing services, according to the release.¹

The shift follows a period in which the company marketed biosimilars itself; BioPharm International reported in August that Enzene had launched its own products in India on its continuous manufacturing platform. Enzene received marketing authorization for romiplostim in India in August 2021 for chronic immune thrombocytopenia in adults.²

It will supply the product from its good manufacturing practice–approved facilities in Pune, India, and support filings with the FDA, the European Medicines Agency and other regulators.¹

What is the reference product, and who does it treat?

Nplate, marketed by Amgen, is a thrombopoietin receptor agonist and an Fc-peptide fusion protein produced in Escherichia coli, administered as a weekly subcutaneous injection.³ The FDA first approved it in 2008.³

The US label covers adults with immune thrombocytopenia (ITP) who had an insufficient response to corticosteroids, immunoglobulins or splenectomy, and patients aged 1 year and older who have had ITP for at least 6 months and responded insufficiently to those therapies.³ ITP is a rare, largely autoimmune disorder marked by low platelet counts.²

In placebo-controlled studies cited in the label, durable platelet responses occurred in 61% of non-splenectomized adults given romiplostim versus 5% given placebo, and in 38% of splenectomized adults versus 0%.^3,4

The release puts the reference product’s 2025 global sales at approximately $1.5 billion.¹

Sources

Adalvo expands biosimilars portfolio through acquisition of romiplostim biosimilar programme from Enzene. News release. Adalvo; October 27, 2026. Accessed October 27, 2026. https://www.adalvo.com/newsroom/romiplostim-biosimilars-enzene-partnership
Enzene Biosciences obtains DCGI approval for romiplostim biosimilar. Indian Pharma Post. August 20, 2021. Accessed October 27, 2026. https://www.indianpharmapost.com/biotech/lite/enzene-biosciences-obtains-dcgi-approval-for-romiplostim-biosimilar-10060
Nplate. Prescribing information. Amgen Inc; revised March 2025. Accessed October 27, 2026. https://www.pi.amgen.com/united_states/nplate/nplate_pi_hcp_english.pdf
Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008;371(9610):395-403. doi:10.1016/S0140-6736(08)60203-2