Sandoz gains commercialization rights to Tysabri biosimilar

Sandoz, a division of Novartis, announced it has entered an agreement with Polish pharmaceutical Polpharma Biologics, regarding the latter’s biosimilar to Biogen’s Tysabri (natalizumab).

Under the agreement, Polpharma will maintain responsibility for the development, manufacture and supply of the candidate, while Sandoz will hold the exclusive rights to commercialize and distribute the product in all markets, upon regulatory approvals.

Polpharma’s natalizumab biosimilar candidate is currently in Phase III clinical development, however, the companies did not disclose a timeframe of filing for regulatory approvals.

Biogen’s Tysabri, a disease-modifying therapy (DMT), was approved for the treatment of multiple sclerosis in 2004 and its global sales reached $1.9bn (€1.73bn) in 2018. To date, there is no approved natalizumab biosimilar commercially available.

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

According to a recent report​, affordability is the most common challenge affecting access to MS therapy in 46% out of 90 countries, while access to DMTs for MS patients represents a considerable challenge for healthcare systems, another piece of research​ showed.

Sandoz currently markets eight biosimilar products in several markets across the globe.