Report on interface biopharmaceuticals/biogenerics
This report analyses the opinions and arguments held by producers of biopharmaceuticals or generic-drug makers as well as regulatory authorities, in order to gain insight on how the near future guidelines will develop. We have reviewed the positions of the FDA and the Emea, the views on regulatory precedent cases from the biologics industry, the possible route of a comparability study approval, the scope of clinical trial necessary, and the scientific and regulatory issues that must be addressed before future guidelines can be initiated.
This report has listed more than 50 approved recombinant products and their global sales figures. Furthermore, we have looked at expiring patents and the biogeneric products that are likely to get a head start in Europe and the US. The most active generic companies and their selected recombinant biologics project portfolio have been evaluated. This report also evaluates the key challenges faced by the generic companies, the expected prize of the second entry biologics, as well as the competitive strategies available to each respective party as they compete for market shares. To gain background and updated information, as well as standpoints from current leaders in this field, a number of key management officers in the industry, key personnel of regulatory authorities, interest organizations, investors and members of the academic research community have been interviewed.<--