Health Canada Approves Its First Biosimilar Trastuzumab, Ogivri

Health Canada has approved Mylan and Biocon’s trastuzumab biosimilar, Ogivri, referencing Herceptin. The product, also approved in the United States, the European Union, and elsewhere, is the first biosimilar trastuzumab to be approved in Canada, and carries indications for HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

Mylan has indicated that it plans to launch Ogivri in Canada during the current quarter of 2019, and it anticipates being the first company to offer a biosimilar trastuzumab to Canadian patients.

Christiane Hamacher, PhD, chief executive officer of Biocon Biologics, said in a statement regarding the approval, “Thousands of patients in Europe, India, and key emerging markets are benefitting from our biosimilar trastuzumab. Biocon Biologics is committed to [addressing] unmet patient needs through its high quality, affordable biologics globally.”

The Canadian approval was based on a data package that included structural and functional characterization; nonclinical studies and a pharmacokinetic evaluation in healthy volunteers and in patients; and a safety, efficacy, and immunogenicity study in patients that compared the biosimilar to the reference product. The data demonstrated that Ogivri is highly similar to Herceptin, with no clinically meaningful differences in terms of efficacy, safety, purity and potency, say the biosimilar developers.

The Canadian Agency for Drugs and Technologies in Health, or CADTH, Canada’s health technology assessment body, lists the biosimilar as currently under funding review for both a 150 mg vial and 440 mg vial. Mylan Chief Commercial Officer Tony Mauro said in a statement that the company looks forward to “continuing our reimbursement discussions with [CADTH] and the Pan-Canadian Pharmaceutical Alliance to ensure that patients have access to Ogivri.”

In the United States, patients continue to wait for access to a biosimilar trastuzumab option; in addition to Mylan and Biocon’s Ogivri, the FDA has also approved Celltrion’s Herzuma, Samsung Bioepis’ Ontruzant, and Pfizer’s Trazimera. None of these products have launched yet in the US marketplace.

However, Roche, maker of the reference Herceptin, predicted in a 2018 earnings call that it would face its first biosimilar trastuzumab competition in the US market in the second half of 2019.