Celltrion remains hopeful for US approval of Herzuma, Truxima despite initial FDA turn-down
IndustryApr 6, 2018
South Korean biopharma company Celltrion expects to obtain US approval for its two biosimilar drugs referencing Roche’s Herceptin and Rituxan by the year’s end, despite the US Food and Drug Administration’s initial turn-down of the two drugs this week. Celltrion said Thursday that the US FDA has issued Complete Response Letters for two of its proposed biosimilars -- Herzuma, referencing Herceptin and Truxima, referencing Rituxan -- and requested supplementary data on the products. A CRL indicate