Biotechnology major Biocon and Mylan NV Wednesday said Canadian health regulator Health Canada has approved Mylan's biosimilar Ogivri co-developed with Biocon, used for the treatment certain breast and stomach cancers.
Ogivri is a biosimilar to Hoffmann-La Roche's Herceptin.
Mylan plans to launch the product this quarter and anticipates potentially being the first company to offer a trastuzumab biosimilar in Canada, the companies said in a joint statement.
Ogivri is the first trastuzumab biosimilar approved in Canada and the second biosimilar from Biocon and Mylan's joint portfolio approved in the market, it added.
Biocon Biologics Chief Executive Officer Christiane Hamacher 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 its commercialisation by Mylan, she added.
Ogivri is used for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer, the statement said.
"As a global leader in the development of complex products, including biosimilar medicines, we are pleased to reach this approval milestone for Ogivri and the opportunity to bring this important treatment option to market for Canadian patients with HER2-positive breast and gastric cancers," Mylan Chief Commercial Officer Tony Mauro said.
Biocon and Mylan's trastuzumab biosimilar is currently approved in more than 65 countries around the world, including the US, the statement said.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products.
Shares of Biocon Ltd closed at Rs 519.60 per scrip on the BSE, up 0.14 per cent from its previous close.
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