South Korean biopharma company Celltrion is planning on filing for US regulatory approval for 2 biosimilars by June 2017. This includes its oncology biosimilar drug rituximab (Truxima), biosimilar to Rituxan, and trastuzumab (Herzuma), biosimilar to Herceptin. Both reference biologics are manufactured by Roche.
Truxima would potentially be indicated for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (RA), Wegener granulomatosis, and microscopic polyangiitis. Truxima is already approved in the European Union (EU). Celltrion is also awaiting approval of Herzuma in the EU after making its filing in October 2016.
Once approved by FDA, the drugs would be marketed via Celltrion’s US marketing and sales partner Teva Pharmaceutical Industries. Celltrion already has 1 biosimilar approved for marketing in the US—Remsima, an infliximab biosimilar of Johnson & Johnson’s Remicade—that is already being sold via partner Pfizer at a 15% discount to the Johnson & Johnson drug.
Celltrion commented that the company plans to quickly drive up their market share in each country to fend off rivals while continuing to raise their reputation in the medical community by accumulating robust prescription data proving the safety and efficacy of their products.
Currently, the FDA has approved 5 biosimilar products, 4 of which are treatments for immune/inflammatory diseases including RA. The other approved biosimilar is Zarxio (filgrastim-sndz), Sandoz’s biosimilar to Amgen’s granulocyte colony-stimulating factor (G-CSF) Neupogen, approved to boost white cell counts after chemotherapy. Truxima and Herzuma would be among the first non-G-CSF oncology biosimilars if approved by the FDA.
The patents of Herceptin and Avastin are expected to retire in 2019. According to some predictions, at least 4 more biosimilars may gain US approval on first-cycle review. (There are some previously rejected applications that may be resubmitted for review). The potential new products include:
Herceptin and Avastin are both blockbuster cancer treatments. Herceptin is indicated for the treatment of breast cancer and stomach cancer; Avastin is indicated for glioblastoma, metastatic colorectal cancer, non-small cell lung cancer, metastatic kidney cancer, advanced cervical cancer, and platinum-resistant ovarian cancer.