Situation: EFPIA asked CRA to respond to DG Competition’s concern regarding the entry of generics and the state of innovation in the European pharmaceutical industry. There was a concern that generic entry was being delayed and that the number of new chemical or biological entities being launched was in decline.
CRA contribution: CRA assembled a comprehensive database on generic entry since 2000 and looked at the reasons why generics do not enter immediately after markets lose exclusivity. In particular, CRA examined the influence of product-specific characteristics and the impact of regulation and how this had changed since 2000. In addition, CRA examined recent market authorizations in the US and Europe and interviewed senior industry experts on the economics of research and development and commercialization. We then assessed the degree to which changes in innovation were due to new technologies, rising costs, or changing regulatory environments.
Result: CRA’s findings have been published as part of the industry submission on explanations for delay in generic entry and the state of innovation.
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