Canada Gears Up For Expected Rise In Biosimilar Filings
Efforts are under way in Canada to strengthen the regulator’s ability to evaluate the growing number of biosimilar filings, and to increase confidence in the biosimilar regulatory framework through targeted outreach and education activities.
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Despite putting it on hold last year, the World Health Organization is keeping its idea of biosimilar naming guidance alive. And at a recent conference it updated delegates on the pilot project for prequalifying biosimilar versions of infliximab and trastuzumab.
In the absence of an international convention on the naming of biological medicines, the Canadian regulator is looking at various options before it decides on a formal approach to distinguish between biologic drugs that have the same non-proprietary name. It wants to adopt an approach that allows accurate identification, is compatible with existing drug information systems and databases, and is easy to implement.
The two countries want the European Commission’s proposals to be more closely examined for their possible negative effect on pharmaceutical investment decisions. The industry federation EFPIA says it is surprised more EU member states aren’t taking the same stance.