Efficacy of MYL 14010 trastuzumab biosimilar confirmed in HERITAGE study- Biocon + Mylan

Mylan N.V. and Biocon Ltd. announced the presentation of data from the HERITAGE study at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 3-7. The study confirmed the efficacy, safety and immunogenicity of MYL 1401O, the proposed biosimilar trastuzumab co-developed by Biocon and Mylan, in comparison to branded trastuzumab (Herceptin).

The HERITAGE study successfully met the predefined endpoints of response equivalency. The response rates at 24 weeks were 69.6% with MYL 1401O combined with taxane chemotherapy versus 64% with branded trastuzumab combined with the same chemotherapy agent. The ratio of overall response and difference in overall response fell within a narrow, pre-defined equivalence margin suggesting equal efficacy of both products. Safety was comparable between treatment groups.

Comment: Herceptin patents are not expected to expire until 2019 in the US but have expired in July 2014 in the EU.

Comment: Hospira/Celltrion won a UK court judgement in 2014 to open the way to an approval of CT P6 which is approved as Herzuma in South Korea for Celltrion but is still to be filed in the EU. Mylan with Biocon has its trastuzumab biosimilar approved in India as Hertaz. Other biosimilars in development are from Amgen/Actavis/Allergan/Synthon ABP 980 , Samsung Bioepis SB 3 and PF 0528004 all in Phase III.