Sandoz Enters Agreement with Polpharma Biologics to Develop and Commercialize Tysabri Biosimilar

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by Joana Carvalho, PhD |

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Sandoz, a division of Novartis dedicated to the development of biosimilars, has entered an agreement with Polpharma Biologics, a biopharmaceutical company also dedicated to the manufacture of biosimilars, to develop and market a biosimilar to Biogen‘s Tysabri (natalizumab).

Tysabri is a disease-modifying therapy (DMT) that was approved for the treatment of relapsing-remitting multiple sclerosis (RRMS) and Crohn’s disease more than a decade ago in both the U.S. and Europe. Like Tysabri, the new biosimilar aims to treat RRMS. The medication is currently undergoing testing in a Phase 3 clinical trial.

A biosimilar is a nearly identical, yet lower-priced version of an original brand medication. Pharmaceutical companies may start producing biosimilars when the patent of the original brand product expires, and after obtaining a license from its manufacturer.

Under the terms of the commercialization agreement, Polpharma will be responsible for developing, manufacturing, and supplying Tysabri’s biosimilar. In turn, Sandoz will hold an exclusive global license over the new biosimilar, and will be responsible for its commercialization and distribution worldwide, once it has been approved by regulatory health agencies. Other terms of the commercialization agreement have not been disclosed.

According to Sandoz, in an era when access to affordable medications to treat multiple sclerosis (MS) is limited, the development and commercialization of a low-cost version of Tysabri may bring new hope to RRMS patients worldwide.

“Patient access to advanced medicines is important for all people diagnosed with a chronic disease, but the challenges are very pronounced for MS patients,” Pierre Bourdage, interim global head of biopharmaceuticals at Sandoz, said in a 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,” Bourdage said.

Jerzy Starak, chairman of Polpharma Biologics, said in his company’s press release: “We are delighted to combine expertise with our collaboration partner Sandoz AG to expand patient access to this important treatment option for RRMS. Natalizumab is the first of a number of late-stage pipeline developments we expect to be announcing in the near future.”

Tysabri’s biosimilar is the fifth proposed biosimilar that has been in-licensed by Sandoz in the past nine months. The company already has eight biosimilars that are part of its global market portfolio, and more than 10  currently in development.

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