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Biotechnology products include complex substances that are produced using living organisms for therapeutic use. While most biotechnology products are licensed as "biological products" under the Public Health Service Act, some are approved as "new drugs" under the Federal Food, Drug and Cosmetic Act. After careful analysis of the science, BIO recommends the following approval standards for follow-on biotechnology products in cases in which statutory marketing protections such as patents and orphan drug exclusivity are no longer available for the approved pioneer product.
Approval of follow-on biotechnology products must be based on the same rigorous standards applied by the FDA for the approval of pioneer biotechnology products. Patients should not have to accept greater risks or uncertainties in using a follow-on product than when they use an innovator's product.
Currently, the science does not exist to provide an alternative to a full complement of data, including clinical evidence, to demonstrate safety and effectiveness for follow-on biotechnology products. As FDA has frequently acknowledged, biotechnology products can be difficult to fully characterize. Also, due to differences in the composition of a biotechnology product or differences in how the product is manufactured, different versions of the same biotechnology product produced by companies other than the innovator will inevitably differ in certain respects from the innovator product. Experience shows that even small product differences can result in significant safety or efficacy differences. Therefore, in the current state of scientific knowledge and technique, a clinical trial remains a fundamental principle for evaluating the safety and effectiveness of a follow-on biotechnology product.
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