Tanvex BioPharma Inc (泰福生技), which focuses on supplying safe and affordable biosimilars, has obtained marketing approval in Canada for its TX01, a biosimilar of Neupogen (filgrastim), the company said yesterday.
Tanvex has signed contracts with Canada-based Mint Pharmaceuticals Inc authorizing the firm to sell TX01 in Canada, it said in a statement.
It is not known when sales of the drug would begin, as discussions with importers are required first and the COVID-19 pandemic might disrupt distribution, Tanvex said.
The prices for TX01 have yet to be decided, as the company still has to negotiate with private insurers, it said.
The gap between the prices of brand drugs and biosimilars is smaller than between brand drugs and generic drugs, as biosimilars require more research and development, and are more complex than generic drugs, Tanvex said.
Sales in Canada of Neupogen and its biosimilars reached more than C$100 million (US$80.68 million) in the 12 months to June, Tanvex said.
Amgen Inc’s Neupogen is used to treat chemotherapy-induced neutropenia and decreases the incidence of infection caused by febrile neutropenia, the company said.
Amgen filed a patent infringement claim against Tanvex in July 2019, but Tanvex reached an agreement with Amgen in March last year.
The company declined to reveal how much it agreed to pay Amgen.
“The expense was lower than the legal expenses if we had chosen to continue engaging in a lawsuit with Amgen,” a company official said by telephone yesterday.
Tanvex said obtaining approval in Canada has made it more confident of receiving approval from the US Food and Drug Administration (FDA), adding that it applied for a biologics license with the agency in October 2018.
The company expects to gain approval from the US FDA in the third quarter of next year, it said.
Tanvex’s cumulative revenue totaled NT$560,000 (US$19,989) for the first three quarters, up 86 percent from a year earlier.
For the first two quarters, it registered a net loss of NT$793 million, less than its net loss of NT$1.17 billion a year earlier, company data showed.
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