Indian Biologics Watch Canada, U.S. Treatments Of Follow-Ons
This article was originally published in PharmAsia News
Executive Summary
India's biologics industry expects the United States and Canada, acting separately, to propose regulations of biologics similar to the practice already underway in Europe. Canada has a guidance document available and expects its second guidance, on subsequent entry biologics, to be released in March. U.S. FDA also has drafted a proposed way of treating follow-on biologics, but that is still in the internal review process. Both Canada and the U.S. are expected to follow the European model. (Click here for more