Follow-On Biologics Presentation
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- FDA cannot rely on an innovator’s unpublished proprietary data, including trade secrets, to approve a follow-on biologic