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The partnership covers an intravenous (IV) nivolumab biosimilar for the European market.

Under the agreement, Shilpa Biologicals will develop, manufacture and exclusively supply the biosimilar from its biologics facility in Dharwad, Karnataka. Orion will exclusively register, market, distribute and sell the product across Europe.

Shilpa will receive development and regulatory milestone payments from Orion. It will also earn long-term supply revenue under the partnership. The financial terms were not disclosed.

The agreement builds on the companies' existing partnership for Recombinant Human Albumin in Europe.

Nivolumab is one of the world's most widely used cancer immunotherapies. The drug generated sales of about $4.1 billion in Europe in 2025, according to IQVIA/IMS data cited by the company.

Shilpa said the partnership aims to expand patient access to a high-quality biosimilar after the originator product loses exclusivity in Europe.

Shilpa Medicare is a diversified pharmaceutical and biotechnology company engaged in the development and manufacture of complex generics, biologics and active pharmaceutical ingredients (APIs). Through its subsidiary Shilpa Biologicals, the company operates a fully integrated biologics platform spanning development, scale-up and commercial manufacturing at its EU-GMP facility in Dharwad, India. Shilpa is known for its focus on innovation, quality and affordability in the global healthcare space.

On a consolidated basis, Shilpa Medicare's net profit soared 642.87% to Rs 107.79 crore while net sales rose 32.09% to Rs 436.99 crore in Q4 March 2026 over Q4 March 2025.

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Shilpa Medicare announced that its wholly owned subsidiary, Shilpa Biologicals, 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 ? bringing two companies together to widen patient access across Europe.

Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients across 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 ? and to help health systems stretch every euro of their oncology budgets further.

In 2025, Nivolumab recorded sales of approximately USD4.1 billion (Source: IQVIA/IMS) Europe ? underscoring the scale of the opportunity that high-quality biosimilars can unlock for patients and healthcare systems across the region.

Under the agreement, Orion will hold the exclusive right to register, market, distribute and sell the nivolumab biosimilar across Europe, and will act as the Marketing Authorisation holder in the territory. Shilpa Biologicals will lead product development and serve as the exclusive long-term commercial manufacturer and supplier for the European market from its advanced biologics facility in Dharwad, India. Shilpa is entitled to receive from Orion certain development and regulatory milestone payments, in addition to supply revenue over the life of the partnership.

Shilpa Biologicals, a material subsidiary of Shilpa Medicare, announced the commissioning of a state-of-the-art Antibody?Drug Conjugate (ADC) GMP manufacturing facility, purpose-built and designed to meet global regulatory approval standards including US FDA, EMA, and other major health authority requirements. The facility is fully operational, with GMP qualification protocols now actively underway, placing Shilpa on a clear path to commercial readiness.

This commissioning reinforces Shilpa's commitment to high-value biologics, complex oncology Drug Substance platforms, and innovation-driven GMP manufacturing. It is a decisive step in its long-term strategy to become a globally relevant CDMO partner for advanced oncology ADC Drug Substance manufacturing ? contributing to differentiated, high-impact treatments for patients worldwide.

Shilpa Medicare announced that its wholly owned subsidiary, Shilpa Biocare intends to make a strategic equity partnership of 30.4% in Gate2Brain. The investment of Euro 7 million includes cash infusion of Euro 0.5 million, equity for services Euro 5.5 million and Euro 1 million for development of project.

Gate2Brain is a Barcelona-based biotechnology company developing peptide-based delivery systems that transport therapeutics across the blood-brain barrier for the treatment of central nervous system diseases. The Company is in pre-clinical stage of product development currently.

Being a strategic shareholder would allow Shilpa to participate in long-term value creation while contributing the manufacturing and regulatory depth required to bring G2B-002 to first-in-human studies and extend its application to other molecules and therapy categories.