Bhutada works on deliver of complex biologics at scale
Shilpa Biologicals Private Limited of India has entered into a co-development and supply agreement with Orion Corporation for intravenous (IV) nivolumab biosimilar referencing one of the world’s most widely used cancer immunotherapies to widen patient access across Europe.
Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients with cancers such as melanoma and lung cancer. As the originator approaches loss of exclusivity in Europe, this partnership aims to put a high-quality, EU-GMP-manufactured nivolumab biosimilar within reach of more patients, reducing healthcare burden. In 2025, Nivolumab recorded sales of approximately USD4.1 billion (Source: IQVIA/IMS) Europe — underscoring the scale of the opportunity.
Under the agreement, Orion will hold the exclusive rights to register, market, distribute and sell the nivolumab biosimilar across Europe. Shilpa Biologicals will lead product development and serve as exclusive long-term commercial manufacturer and supplier for Europe. Shilpa will receive development and regulatory milestone payments, and supply revenue over life of partnership.
“Extending our partnership with Orion into immuno-oncology is a defining moment for Shilpa Biologicals,” said Vishnukant Bhutada, Managing Director, NSE-listed Shilpa Medicare. “It reflects the trust our partners place in our quality, our science and our ability to deliver complex biologics at scale.”
“We are pleased to add yet another product to our strategic partnership with Shilpa,” said Satu Ahomäki, EVP Generics and Consumer Health, Orion Pharma. “This agreement strengthens our operations in hospital segment in Continental Europe, and reflects progress of implementation of our division’s strategy to give everybody an access to affordable quality medicines,” Ahomaki said on 6 July.
Shilpa Medicare, headquartered in India, is a diversified pharmaceutical and biotechnology company developing complex generics, biologics and APIs. Through Shilpa Biologicals, it operates an integrated biologics platform spanning development, scale-up and commercial manufacturing at its EU-GMP facility in Dharwad, Karnataka.
Orion Pharma is a globally operating Nordic pharmaceutical company and a builder of well-being for over a hundred years. It develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients, with an extensive portfolio of proprietary and generic medicines and consumer health products. Its core R&D areas are oncology and pain, with proprietary products treating cancer, respiratory and neurological diseases, among others. In 2025, net sales amounted to EUR 1,890 million, with about 4,000 employees worldwide. Fiinews.com
