Sandoz in Deal to Commercialize Biosimilar Natalizumab

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A global agreement with Polpharma Biologics gives Sandoz commercialization rights to a proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis.

Sandoz, a Novartis division, announced on Sept. 3, 2019 that it has entered into a global commercialization agreement with Polpharma Biologics, a Poland-based biopharmaceutical company, for a proposed natalizumab biosimilar. The drug candidate is in Phase III clinical development for treating relapsing-remitting multiple sclerosis (RRMS).

Under the agreement, Polpharma Biologics will have responsibility for the development, manufacture, and supply of the proposed biosimilar natalizumab. Sandoz, through an exclusive global license, will commercialize and distribute the therapy in all markets upon approval. Financial details of the deal were not disclosed.

The proposed biosimilar natalizumab references Tysabri (natalizumab) is one of Biogen’s top-selling biologics with approximately $1.9 billion in 2018 sales. Tysabri is a disease-modifying therapy (DMT) approved by FDA in November 2004 for treating relapsing forms of MS. Today, Tysabri is indicated for both multiple sclerosis and Chrohn’s disease.

“Patient access to advanced medicines is important for all people diagnosed with a chronic disease, but the challenges are very pronounced for MS patients,” said Pierre Bourdage, ad interim global head of Biopharmaceuticals, Sandoz, in a company press release. “By nature, biosimilars create competition and cost savings, which are proven to make room in healthcare systems to treat more patients. With this agreement, we hope to build on our MS experience with small molecules and complex generics, and ultimately provide patients with expanded access to a DMT that healthcare systems may otherwise not be able to provide.”


The addition of proposed biosimilar natalizumab expands the Novartis/Sandoz portfolio across small molecules, complex generics, biosimilars, and innovator medicines.

Source: Novartis