News

On March 9, 2020, FDA and the US Federal Trade Commission (FTC) held a public workshop to discuss issues related to biosimilars in the United States. According to FDA and FTC, the workshop’s purpose was to discuss the “FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and deter anticompetitive behaviors in the biologic marketplace.” The workshop included speakers from the FDA, FTC, the pharmaceutical industry, biosimilar organizations, and patient advocacy groups. A public comment session allowed stakeholders to inform FDA and FTC of issues relevant to their businesses and organizations.

In BioPharm International, Venable Fitzpatrick’s April Breyer Menon and Ha Kung Wong discuss important topics at the FDA/FTC Workshop, including:

  • FDA’s recent draft guidance “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers”
  • Exclusionary contracting, discounts, rebates, reimbursement, formulary placement
  • Interchangeability
  • Uncertainty
  • Market Shares
  • Product-specific FDA guidances
  • Savings sharing programs

Read the entire article here.


Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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