The biosimilars realm of oncology has been surrounded by a burst of clinical and regulatory news this week, with the read out of phase III findings and extension data, legality issues, and more.
- Esteva FJ, Baranau YV, Baryash V, et al. Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial [published online ahead of print August 19, 2019]. Cancer Chemo and Pharma. doi: 10.1007/s00280-019-03920-4.
- Celltrion and Teva announce FDA approval of Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin, for the treatment of HER2-overexpressing breast cancer for certain indications [news release]. Incheon, South Korea, and Jerusalem, Israel: Celltrion. Published December 14, 2018. https://bit.ly/2KY6s8i. Accessed December 17, 2018.
- Esteva FJ, Lee S, Yu S, et al. 24 months results from a double-blind, randomized phase III trial comparing the efficacy and safety of neoadjuvant then adjuvant trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer (EBC). Lancet Oncol. 2017;18(7):917-928. doi: 10.1016/S1470-2045(17)30434-5.
- Amgen And Allergan Announce Positive Top-Line Results From Comparative Clinical Study Of ABP 798, Biosimilar Candidate To Rituxan® (Rituximab). Amgen. Published August 22, 2019. https://bit.ly/2L0pACF. Accessed August 22, 2019.
- McBride H, Maher G, Sweet H, Foltz I, Kuhns S. Functional similarity of proposed biosimilar ABP 798 with rituximab. Blood. 2017;130:5001. bloodjournal.org/content/130/Suppl_1/5001.
- United States Court of Appeals for the Federal Circuit. Genentech, Inc., Plaintiff-Appellant City of Hope, Plaintiff v. Immunex Rhode Island Corporation, Amgen Inc., Defendants-Appellees. Published August 16, 2019. https://bit.ly/2zh99wo. Accessed August 22, 2019.
- UnitedHealthcare. Network bulletin. Published August 2019. https://bit.ly/2KQCZhO. Accessed August 22, 2019.
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