Celltrion and Teva\'s Herceptin biosimilar secures FDA approval in breast cancer

Celltrion and Teva's Herceptin biosimilar secures FDA approval in breast cancer

06:33 EST 18 Dec 2018 | Pharmafile

Israeli and South Korean-based drug makers Teva and Celltrion are set to move in on the market share occupied by Roche and Genentech’s Herceptin (trastuzumab) with the announcement that their own biosimilar version of the drug has received approval from the FDA.

Herzuma, as the HER2/neu receptor antagonist biosimilar is known, was shown through a “comprehensive data package inclusive of foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy and safety data” to be clinically non-inferior to its reference product.

Celltrion and Teva\'s Herceptin biosimilar secures FDA approval in breast cancer

Celltrion and Teva's Herceptin biosimilar secures FDA approval in breast cancer

Israeli and South Korean-based drug makers Teva and Celltrion are set to move in on the market share occupied by Roche and Genentech’s Herceptin (trastuzumab) with the announcement that their own biosimilar version of the drug has received approval from the FDA.

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