European Biosimilar Access
Orion and Shilpa Medicare Partner to Develop, Supply Nivolumab Biosimilar in Europe
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Shilpa Medicare Limited has signed a co-development and supply agreement with Orion Corporation to bring a biosimilar version of nivolumab — a major cancer immunotherapy drug — to European patients, according to Financial Post. The deal comes as the original nivolumab drug, sold by Bristol-Myers Squibb under the brand name Opdivo, approaches the end of its patent exclusivity in Europe.
Under the agreement, Shilpa's wholly owned subsidiary, Shilpa Biologicals Private Limited, will lead all product development and act as the exclusive long-term manufacturer and supplier for the European market, Financial Post reported. Shilpa Medicare will receive development milestone payments, regulatory milestone payments, and ongoing revenue across the life of the partnership.
What Nivolumab Does and Why It Matters
Nivolumab is an intravenous immunotherapy drug used to treat several types of cancer, including lung, kidney, and skin cancers. It works by helping the body's immune system find and attack cancer cells. It is one of the best-selling cancer drugs in the world. A biosimilar is a near-identical copy of a biological drug made once the original patent expires.
Biosimilars typically cost less than the original drug. That lower cost can help more patients get access to treatment. The goal of this partnership, according to Montreal Gazette, is specifically to "widen patient access across Europe" as the originator drug nears its loss of exclusivity.
Shilpa Biologicals Takes the Lead on Development and Manufacturing
Shilpa Biologicals will handle the full development process for the IV nivolumab biosimilar. The subsidiary will also serve as the sole commercial manufacturer for the European market on a long-term basis, Financial Post reported. This gives Shilpa a central and lasting role in the product's entire lifecycle — from lab to patient.
Shilpa Medicare is based in Dharwad, India. The company has been growing its biologics division in recent years. This agreement deepens an existing partnership with Orion, meaning the two companies have worked together before. The expanded deal now covers a high-value oncology product targeting one of the world's largest pharmaceutical markets.
Orion Strengthens Its European Hospital Business
For Orion Corporation, the Finnish pharmaceutical company, the deal strengthens its position in the hospital segment in Continental Europe, according to Stratford Beacon Herald. Hospitals are a key sales channel for IV cancer drugs. Adding a biosimilar version of a blockbuster immunotherapy could significantly boost Orion's oncology portfolio.
Orion already markets and sells medicines across Europe. Partnering with Shilpa Biologicals for manufacturing lets Orion focus on commercialization and distribution. The arrangement is a common model in the biosimilars industry, where development and sales responsibilities are split between specialized partners.
A Growing Market as Key Cancer Drug Patents Expire
The global biosimilars market is expanding rapidly as patents on major biological drugs expire. Nivolumab generated billions of dollars in annual sales for Bristol-Myers Squibb. Once biosimilars enter the market, prices typically fall, and competition increases. Europe has been one of the most active markets for biosimilar adoption worldwide.
This agreement positions both Shilpa Medicare and Orion to capture a share of that opportunity. Shilpa gains milestone payments and long-term revenue. Orion gains a reliable supply chain and a new oncology product. Both companies stand to benefit if the biosimilar wins regulatory approval and reaches European patients, Daily Herald Tribune reported.
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