Type of information: Acceptation for review of a NDA
Product name: Ontruzant® - SB3
Compound: biosimilar version of trastuzumab
Therapeutic area: Cancer - Oncology
- biosimilar/monoclonal antibody. Trastuzumab is a recombinant humanized monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER2). After binding to HER2 on the tumor cell surface, trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Ontruzant® is a biosimilar medicinal product. It is highly similar to the reference product Herceptin® (trastuzumab), which was authorised in the EU on 28 August 2000.
Company: Samsung Bioepis (Republic of Korea)
Disease: early breast cancer, metastatic breast cancer, metastatic gastric cancer
- • On December 20, 2017, Samsung Bioepis announced that the FDA has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptin® i (trastuzumab). SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in the United States (US). If approved, it will be commercialized in the US by Merck&Co.
- • On September 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive
opinion, recommending the granting of a marketing authorisation for Ontruzant®, intended for the treatment of early and metastatic breast cancer, and metastatic gastric cancer. Ontruzant® will be available as a 150 mg powder for concentrate for solution for infusion. This is the first biosimilar candidate referencing Herceptin®i(trastuzumab) to receive a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use
- Ontruzant® will be commercialized in the European Union by Merck&Co.
- • On October 3, 2016, Samsung Bioepis announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB3, a biosimilar candidate referencing Herceptin® (trastuzumab). The MAA for SB3 was submitted in August 2016. SB3 is Samsung Bioepis’ fifth biosimilar candidate submitted to the EMA, following SB4 (etanercept), SB2 (infliximab), SB9 (insulin glargine) and SB5 (adalimumab). SB4 and SB2 have since received regulatory approval from the European Commission. If approved, the marketing and distribution of SB3 in Europe will be handled by Merck&Co.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
UE authorization: 2017-11-15
Favourable opinion UE: 2017-09-14
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: