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• FDA cannot rely on an innovator’s unpublished proprietary data, including trade secrets, to approve a follow-on biologic

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