Adalvo Acquires Enzene’s Romiplostim Biosimilar Programme

Adalvo has acquired a romiplostim biosimilar programme from Indian biotechnology company Enzene Biosciences, strengthening its portfolio of complex biological medicines and marking a major step in its expansion into the global biosimilars market.

The acquired programme is based on Nplate (romiplostim), a biological medicine used to treat immune thrombocytopenia (ITP), a condition in which the immune system destroys platelets, increasing the risk of bruising and bleeding.

Romiplostim works by stimulating the bone marrow to produce more platelets. It is used in adults and children with chronic ITP who have not responded adequately to other treatments.

According to the companies, the reference product Nplate generated approximately $1.5 billion in global sales in 2025, highlighting the commercial opportunity for a biosimilar version.

The programme was developed using microbial cell line technology, making it a technically complex biological medicine. Enzene has already taken the product from cell line development through regulatory approval and commercial supply in India.

Under the agreement, Enzene will continue to support the programme as its development and manufacturing partner. The company will also assist with regulatory submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other international regulatory authorities.

The product will be manufactured at Enzene’s Good Manufacturing Practice (GMP)-approved facilities in Pune, India. This arrangement will allow Adalvo to use Enzene’s scientific and manufacturing expertise while focusing on global development, regulatory activities and commercialisation.

For Adalvo, the acquisition represents an important move beyond its established specialty pharmaceutical business into complex biological medicines. The company plans to build a broader biosimilars portfolio covering different stages of development, manufacturing, regulatory approval and commercial supply.

Anil Okay, CEO of Adalvo, said biosimilars are an important part of the company’s long-term growth strategy. He added that the agreement brings together Enzene’s scientific and manufacturing capabilities with Adalvo’s global development and commercial network.

For Enzene, the transaction marks a strategic shift towards becoming a specialised contract development and manufacturing organisation (CDMO) for biologics.

Himanshu Gadgil, CEO of Enzene, said the partnership would allow the company to focus on developing, scaling and manufacturing complex biological medicines for pharmaceutical partners worldwide. He also highlighted that Enzene would continue supporting the romiplostim programme through development and manufacturing activities.

The company has built capabilities across cell line development, process development, clinical supply and commercial manufacturing. Its facilities in India and the United States support its growing international CDMO operations.

The acquisition also reflects the growing interest in biosimilars as pharmaceutical companies look for ways to expand access to biological medicines and strengthen their product portfolios.

With the romiplostim programme, Adalvo aims to establish a stronger position in the global biosimilars market, while Enzene will continue to play an important role in the product’s development and manufacturing.

The financial details of the transaction were not disclosed.