Regulatory Developments for Complex Drugs

The U.S. Food and Drug Administration (FDA) is currently working toward implementing the Biologics Price Competition and Innovation Act (BPCI) of 2009, which establishes an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" to or "interchangeable" with a drug regulated under the Public Health Service Act. This international, scientific conference will focus on considerations for the non-biological complex drug regulatory approval pathway given the established guidelines for biosimilars. Plenary sessions will address the most recent regulatory developments, experimental design, interchangeability and immunogenicity issues for follow-on versions of complex drugs from the perspective of key audiences, including industry, regulatory agencies, physicians, and consumers. Click here to register.