FDA approves another biosimilar: green light to Teva and Celltrion’s Herzuma yesterday

FDA is approving biosimilars at an increasing rate, in the attempt to reduce the high costs of US healthcare system. Yesterday the turn came for Herzuma (trastuzumab-pkrb), the biosimilar to Roche’s cancer treatment Herceptin, developed by Korea-based Celltrion and then partially licensed to Teva. The product was approved for the treatment of metastatic breast cancer in combination with chemotherapy.

Importantly, Celltrion and Teva Pharmaceutical Industries in October 2016 entered into an agreement under which Celltrion sold Teva its commercialization rights in the US and Canada to two biosimilars developed by Celltrion. The two drugs are Roche’s blockbuster Herceptin and Biogen’s antiinflammatory Rituxan, which last year generated a combined sales volume of $6.5m in the US and Canada.

(Source: Teva)