Short Abstract

In the United States, the Patient Protection and Affordable Care Act (Affordable Care Act) was signed into law on March 23, 2010, amending the Public Health Service Act (PHS Act) to create an abbreviated licensure/approval pathway for biological products, which are demonstrated to be highly similar (biosimilar) to or interchangeable with an FDA-licensed biological product. The said “Abbreviated Approval Pathway” was established by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), enhancing competition and better patient access and lower cost to consumers.

In an effort to assist industry in developing biosimilar products of currently approved biological products, the United States Food and Drug Administration (FDA) has recently issued three draft guidance documents.

This webinar is aimed at helping industry expedite the development process of the biosimilar products and thus, is designed to dissect the guidance documents and FDA’s current thinking on the approval path of the biosimilar products and to further provide practical and actionable perspectives by increasing awareness and familiarity of the regulatory requirements.

At the end of the webinar, you will get empowered in a way that you would plan, develop and execute efficiently and effectively.

The presentation will cover the following areas:

• Review of the Public Health Service Act (PHS Act) governing the abbreviated licensure pathway for biosimilar products.
• Review of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), enacted on March 23, 2010
• FDA’s focus on therapeutic products.
• Overview of general scientific principles/considerations for demonstrating biosimilarity.
• Overview of analytical and multiple factors for FDA’s assessment and determination of biosimilarity.
• What is residual uncertainty?
• How to address residual uncertainty.
• FDA’s recommendations when describing the safety, purity, and potency of the proposed biosimilar product.
• FDA’s recommended approach in developing biosimilar products.
• FDA’s approach during review of biosimilar applications.
• How to demonstrate biosimilarity (e.g, requirements).