On 1 December 2017, the US Food and Drug Administration (FDA) approved its first trastuzumab biosimilar.
The trastuzumab biosimilar, Ogivri (trastuzumab-dkst), is produced by India-based biologicals specialist Biocon and partner Mylan. The pair submitted their application for their trastuzumab biosimilar (MYL‑1401O) to FDA in November 2016. The application was delayed, however, after Mylan received a complete response letter (CRL) from FDA relating to the update of the biosimilar application with chemistry, manufacturing and control (CMC) data after Biocon made plant modifications requiring ‘requalification’ at its Bangalore facility .
The product is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had worldwide sales of CHF 6.5 billion (US$6.6 billion) in 2015 . The patents on Herceptin expired in Europe in July 2014 and will expire in the US in June 2019 .
Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is used to treat certain breast cancers.
Ogivri has been approved for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumours overexpress the HER2 gene (HER2+).
FDA said that ‘approval of Ogivri is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data’.
Ogivri has been approved as a biosimilar to Herceptin, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
The approval marks FDA’s second cancer biosimilar and the first for the treatment of breast and stomach cancer.
Biocon and Mylan had their trastuzumab ‘similar biologic’ (CanMab/Hertraz) approved in India back in October 2013 . The pair also submitted an application for approval of their trastuzumab biosimilar to the European Medicines Agency in December 2017 .
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
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Source: Biocon, Mylan, US FDA