Sandoz, Polpharma score European approval for first Tysabri biosimilar for multiple sclerosis

Fol­low­ing quick­ly on the heels of US biosim­i­lar ap­provals, Am­s­ter­dam-based Pol­phar­ma Bi­o­log­ics scored a Eu­ro­pean Com­mis­sion au­tho­riza­tion for its Tysabri (na­tal­izum­ab) biosim­i­lar for mul­ti­ple scle­ro­sis, the com­pa­ny an­nounced Tues­day.

The biosim­i­lar, mar­ket­ed as Tyruko, was de­vel­oped by Pol­phar­ma but will be com­mer­cial­ized by its part­ner San­doz, thanks to a 2019 agree­ment. The FDA ap­proved Tyruko in Au­gust, mak­ing it the first-ever na­tal­izum­ab biosim­i­lar in the US. The EC au­tho­riza­tion al­so marks the first biosim­i­lar for the drug to come to mar­ket in Eu­rope.

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