April 25, 2024

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[THE INVESTOR] Samsung Bioepis said on Dec. 20 that it has submitted its application to the US Food and Drug Administration seeking approval to launch a biosimilar version of Roche’s breast cancer therapy Herceptin.

The proposed biosimilar candidate SB3 is indicated for treatment of certain breast and gastric cancers. The company already received the European Commission’s permission for marketing in November this year for SB3, named Ontruzant in Europe.

Herceptin raked in US$6.7 billion for Roche last year.

Global drug makers are scurrying to sell their knockoff drugs in the US. Leading the pack is Mylan which has won the first US approval for a Herceptin biosimilar this month. Celltrion and Amgen filed for approval in July while Pfizer has its version under phase 3 clinical trials.

The companies will be able to launch their products after the last composition of matter patent covering Herceptin in the US expires in 2019.

Having nearly US$2.5 billion in sales at stake, Roche has sued Pfizer to keep its biosimlar off the US market by claiming its proposed biosimilar would infringe on 40 of its patents.

By Park Han-na (hnpark@heraldcorp.com)