Patients should not have to accept greater risks or uncertainties in using a follow-on product than when they use an innovator's product.
This presentation covers:
BIO's Position on Follow-On Biologics
(FOBs)
Biological Products vs. Chemical “Small-Molecule” Drugs
Generics vs. Follow-Ons
Immunogenicity
Naming of FOBs
Conclusions
BIO’s Position on FOBs
Ensuring Patient Safety
Patients should not have to accept greater risks or uncertainties in using a follow-on product than when they use an innovator's product.
A clinical trial remains a fundamental principle for evaluating the safety and effectiveness of a follow-on biotechnology product
Protecting Incentives for Innovation, including Intellectual Property Rights
Any approval of a follow-on biologic must be carefully crafted so that it does not create disincentives to research and development of innovative biotechnology products
FDA cannot rely on an innovator’s unpublished proprietary data, including trade secrets, to approve a follow-on biologic
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