Mylan, Biocon Say Health Canada Approves Trastuzumab Biosimilar Ogivri

(RTTNews) - Mylan N.V. (MYL) and Biocon Ltd. said Wednesday that Health Canada has approved Mylan's Ogivri, or trastuzumab, a biosimilar to Herceptin, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Mylan co-developed Ogivri with Biocon.

Ogivri is the first trastuzumab biosimilar approved in Canada. It is also the second biosimilar from Mylan and Biocon's joint portfolio to be approved in the market.

Mylan said it plans to launch the product this quarter and anticipates potentially being the first company to offer a trastuzumab biosimilar in Canada.

Health Canada's approval of Ogivri was based on data from structural and functional characterization using multiple orthogonal techniques, nonclinical studies and pharmacokinetic evaluation in healthy subjects and patients. It was also based on a safety, efficacy and immunogenicity study in relevant patient populations, which compared Ogivri to Herceptin.

The companies noted that the data demonstrated that Ogivri is highly similar to Herceptin with no clinically meaningful differences in terms of efficacy, safety, purity and potency.

Mylan's Chief Commercial Officer Tony Mauro said, "We look forward to continuing our reimbursement discussions with the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Pan-Canadian Pharmaceutical Alliance (pCPA) to ensure that patients have access to Ogivri."