Norton Rose Fulbright advises Zydus on its strategic partnership with Formycon for exclusive licensing and supply of a biosimilar in the United States and Canada

Global law firm Norton Rose Fulbright advises Zydus Lifesciences Global FZE (Zydus) on its strategic partnership with Formycon AG (Formycon) for the exclusive licensing and supply of FYB206, a biosimilar to a major humanized monoclonal antibody in the field of oncology (Reference Product), in the United States and Canada.

Under the licensing and supply agreement, Formycon will finalize the development, prepare and file the regulatory dossier, and supply the product, while Zydus will be responsible for the commercialization of the biosimilar in the United States and Canada.

The Reference Product belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology, the Reference Product is currently one of the world's best-selling drugs, underscoring the substantial oncology demand and market potential across the world.

Zydus is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries.

Formycon (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index.

Lead partner Dr Heiko Bertelmann (corporate/M&A, Hamburg), Head of Life Sciences and Healthcare EMEA, comments: "This partnership combines Formycon's development and regulatory expertise with Zydus's commercialization strength, to enable patient access to an oncology biosimilar in the U.S. and Canada. Our legal advice to Zydus on this transaction is a testimonial to our strong, broad and global Life Sciences and Healthcare practice and the seamless international collaboration that defines Norton Rose Fulbright."

The Norton Rose Fulbright team led by partner Dr Heiko Bertelmann included associate Marcel Gießler (corporate/M&A, Hamburg), partner Clemens Rübel (IP, Munich) and senior associate Maximilian Schmitz (IP, Munich), as well as partner Dr Tim Schaper (antitrust law, Hamburg).