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Biosimilar medicines: Sandoz will comercialise Polpharma’s SM drug

polpharma biologics

Polpharma Biologics and global generic giant Sandoz will jointly launch a biosimilar to the multiple sclerosis (SM) biological drug. This is the result of a contract signed last Tuesday for the commercialisation of the product.

Polpharma will fight for a billion-dollar market

Polpharma is developing a biosimilar to the Tysabri drug (natalizumab) produced by Biogen from 2013. Tysabri was launched in 2004 and is used to treat SM emission (affecting 85% of patients). In 2018, its global sales amounted to nearly $1.9bn, which accounted for 17% of the Group’s revenues. A year earlier, however, the revenues were higher by over $100m. The appearance of equivalents on the market will certainly contribute to a further decrease in sales.

The first natalizumab patents expired in the EU and the US in 2015 and the next ones expire in 2020. However, some treatment methods will be protected until 2027.

Sandoz has a global exclusive agreement

A biosimilar drug developed by Polpharma is currently in phase III of clinical trials. Under the agreement with Sandoz, the Polish company will be responsible for further development of the substance, as well as its production after its introduction to the market. The Swiss concern will take care of the global commercialisation of the product. This means introduction to distribution and sale after registration on all markets on the basis of a global exclusive licence.

The value of the agreement was not disclosed to the public. However, according to estimates by Puls Biznesu, Polpharma may receive an upfront payment of several dozen million dollars. This is not the first such agreement signed by Sandoz. As the newspaper recalls, in April 2019 the company signed a similar agreement with the Taiwanese company EirGenix. It concerned global rights to a biosimilar to trastuzumab.

Polpharma Biologics is currently working on six biosimilars.

More on this topic in the PMR report: Biological and biosimilar medicines market in Poland 2019. Market analysis and development forecasts for 2019-2024.

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