Am­gen sues San­doz to block biosim­i­lar of block­buster bone drug

Am­gen is su­ing San­doz in fed­er­al court over the com­pa­ny’s plan to seek FDA ap­proval of a biosim­i­lar ver­sion of deno­sum­ab, al­leg­ing 42 in­stances of patent in­fringe­ment for the block­buster bi­o­log­ic.

The com­plaint, filed Mon­day in New Jer­sey, names San­doz, its sub­sidiary Lek Phar­ma­ceu­ti­cals, and its par­ent com­pa­ny No­var­tis. The law­suit cen­ters on San­doz’s plan to bring to mar­ket a biosim­i­lar ver­sion of deno­sum­ab — brand­ed as Pro­lia and Xge­va. San­doz’s BLA for a biosim­i­lar ver­sion of the an­ti­body was ac­cept­ed by the FDA in Feb­ru­ary.

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