Biocon Ltd and Mylan N V have received approval from Health Canada for the latter's Ogivri (trastuzumab) drug, making it the first biosimilar of Hoffmann-La Roche's oncology formulation Herceptin to be approved in that country. Mylan is planning to launch the product during this quarter and hopes to become the first company to offer a trastuzumab biosimilar in Canada, a joint announcement said.
Co-developed with Biocon, Ogivri is for the treatment of breast cancer and metastatic stomach cancer. The drug is the second biosimilar from Biocon and Mylan’s joint portfolio to be approved in the market. The partnership has already launched the drug in Europe.
Christiane Hamacher, CEO, Biocon Biologics said, “We are pleased to enable access to Ogivri, a high quality biosimilar trastuzumab co-developed and manufactured by Biocon as an affordable treatment option for HER2-positive breast and gastric cancer patients in Canada." The Health Canada approval granted to Ogivri will pave the way for the drug's commercialisation by Mylan, said the official. The global market for Herceptin is around $7 billion. HER2-positive breast cancer is the kind that tests positive for a particular protein that promotes the growth of cancer cells.
Mylan’s Chief Commercial Officer Tony Mauro commented, “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.”
The data submitted by the companies demonstrated that Ogivri is highly similar to Herceptin, with no clinically meaningful differences in terms of efficacy, safety, purity and potency. Biocon and Mylan’s trastuzumab biosimilar is currently approved in more than 65 countries around the world, including the US.
The US Food and Drug Administration (FDA) approved Ogivri, the first biosimilar of Trastuzumab in December, 2017 for the treatment of HER2-Positive breast and gastric cancers.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Ogivri is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace.
Mylan has exclusive commercialisation rights for the product in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialisation rights for the product in the rest of the world.
The partnership has launched Fulphila, biosimilar of pegfilgrastim used for the treatment of patients undergoing chemotherapy, in US which has contributed significantly to the biologics business performance of Biocon in FY19. The partnership has also launched Semglee, a biosimilar insulin glargine and Ogivri in Europe.
Analyst from Ashika Institutional Research in a recent report has said that it is expected that Ogivri can generate $118mn revenue in FY21E and $125mn in FY22E for Biocon.