Biotech major Biocon on Wednesday said it would soon market in Canada its anti-breast cancer drug Ogivri, which it co-developed with the US-based Mylan, following approval by the Canadian health regulator.
"As Ogivri is the first drug approved by Health Canada and the second biosimilar co-developed with Mylan, we plan to market it in this (first) quarter in Canada as an affordable treatment option for breast cancer patients," said the company in a statement.
The drug can also be used to treat gastric cancer. "The approval will pave the way for the drug's commercialisation by our partner Mylan. Thousands of patients in Europe, India and key emerging markets are benefiting from it," said the statement.
Biocon's biologics arm is committed to address the unmet patient needs through affordable medicines, globally. The biosimilar has approval in 65 countries, including the US.
"As a leader in making drugs, including biosimilar medicines, the Canadian approval is a milestone for Ogivri, which is an important treatment option to market for Canadian patients," said Mylan's Chief Commercial officer Tony Mauro.
The regulatory approval was based on data from structural and functional characterisation using multiple orthogonal techniques, non-clinical studies and pharma-cokinetic evaluation in healthy subjects.
The data showed that Ogivri is similar to Herceptin with no clinical differences in terms of efficacy, safety, purity and potency.