A generic drug is one that contains the same active ingredient as a previously approved innovative medicine, meets certain quality manufacturing requirements and contains labeling that is identical (or highly similar) to that of the innovative drug.1 Generics are approved by a different regulatory pathway than innovative medicines. In essence, the generic is approved based upon the finding of safety and efficacy that was established by the innovator.
By 2015, over $100 billion in current brand name drugs will become generic in mature markets.2 Current forecasts also predict that over 60% of drug sales in large emerging markets like Brazil, China and India will be generics produced by both multinational and local manufacturers.3 Widely available generics have decreased overall drug costs and increased patient access, particularly in the U.S., which has among the lowest generic prices and highest generic usage of any market.4
Our Position and Key Messages
Bristol-Myers Squibb supports the development and use of bioequivalent, small molecule generic drugs approved by regulatory authorities and commercialized only when intellectual property protections have expired or are no longer enforced by the innovator. We believe that generics can increase the availability of affordable medicines, improve patient adherence, help contain health care costs, and provide a channel to expand patient access to important medicines. In countries where intellectual property rights are respected, the increased use of generics should provide government payers, in particular, with greater financial ability in health budgets to reimburse innovative drugs that address unmet medical patient need.
Bristol-Myers Squibb supports the use of a generic drug when the prescribing physician retains the discretion to oppose substitution of an innovative product with a generic if (s)he considers it inappropriate for a given patient, and when the same level of quality and security as the original product is ensured. Generics should comply with regulatory standards. Some generics may, in fact, be “similars,” with chemical properties similar to original innovator products, but lacking true bioequivalence, which may pose safety or other concerns for patients.
We believe that generic drugs have an important place in health care systems around the world and that pro-innovation policies are entirely consistent with support for access to quality and affordable generics in the future. After all, today’s innovative medicines will be tomorrow’s generics.
1 A generic drug is not identical, although it does contain the same chemically identical active ingredient as the innovative product. A generic can possess no less than 80% of the availability when substituted for the brand reference product, and the reciprocal limit of 125% when the brand reference product is substituted for the generic product.
2 IMS Health Institute for Health Informatics, The Global Use of Medicines: Outlook Through 2015, May 2011.
3 IMS Health, Market Prognostication Report: 2012-2016, March 2012.
4 Ibid, In the U.S., the Market Prognostication Report (2012-2016) forecast that 81% of dispensed prescriptions in 2012 would be generics, increasing to 85% by 2015.