Biosimilar Action Plan

In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and agency action” related to drug pricing issues.  Since that time, many industry commentators questioned whether any of the vague goals in the Blueprint would or could be turned into concrete action.

This month, the Trump Administration has attempted to answer that question through a variety of HHS and FDA initiatives.  Here’s what you need to know about drug pricing developments so far in July. Continue Reading Significant Drug Pricing Developments in July – Here’s What You Need To Know

As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on “FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.” The hearing notice, to be published in the Federal Register on July 25th (see here), notes that the Agency has determined that a public hearing is the most effective way for it to hear from a diverse and broad group of stakeholders, from patients and health care providers to manufacturers and professional organizations. Continue Reading Biosimilars Action Plan Update: Public Hearing Scheduled

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for stimulating and improving the marketplace for biosimilars in the U.S. The newly released Biosimilar Action Plan (BAP) is a 9-page, easy-to-read document. As Commissioner Gottlieb indicated in his statement about the release, the BAP is “is aimed at promoting competition and affordability across the market for biologics and biosimilar products.”

As we’ve previously discussed on this blog (see here, here, and here), the Food and Drug Administration under Commissioner Scott Gottlieb has been at the forefront of efforts to “Tackle Drug Competition to Improve Patient Access” – as per a June 27, 2017 FDA press release related to Dr. Gottlieb’s multi-pronged DCAP. In the absence of direct authority over pricing-related issues, as the Commissioner regularly mentions in his public appearances, Dr. Gottlieb and his leadership team nonetheless have demonstrated creativity and commitment towards improving various FDA-related bottlenecks for drugs and biologics – for players in both the innovator and follow-on product environments.  Continue Reading FDA’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition