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US GAO Report Identifies Challenges for Generic Versions of Nonbiological Complex Drugs
On January 16, 2018, the U.S. Government Accountability Office (GAO) released a report that examines the challenges of reviewing generic versions of nonbiological complex drugs (NBCDs). The report underlines the scientific challenges involved when demonstrating equivalence between brand and generic NBCDs. GAO recommends that FDA increases transparency, and publicly announces its plans to issue and revise guidance for complex drugs.
“The NBCD Working Group is proud to have contributed to this diligent report,” said Jon de Vlieger from the NBCD Working Group. “The GAO findings recognize significant challenges when demonstrating therapeutic equivalence for NBCDs, and the report’s concluding recommendations will improve the communication between FDA and stakeholders.”
The report lists additional steps proposed by stakeholders to address the challenges presented. The views on these additional steps, such as amending current regulatory pathways, are mixed. De Vlieger: “We are confident that the report will encourage constructive discussions and strengthen the scientific basis for evaluation of NBCD follow-on versions.”
The NBCD working group encourages multi-stakeholder discussions and dissemination of data. “We look forward to continuing collaboration with all stakeholders involved: scientists from brand and generic companies; academia; and regulatory bodies from different parts of the world,” said De Vlieger. “We have to work together towards defining the critical quality attributes and the science-based approval and post-approval standards for NBCDs, to ensure patient safety and benefit.”
A copy of the GAO report can be found HERE.
For more information, please contact Jon de Vlieger: jon.devlieger[at]lygature.org.
About the NBCD Working Group
The NBCD Working Group has the mission to ensure patient safety and benefit by driving discussions on science-based approval and post-approval guidelines for NBCDs. The group is a public-private partnership with worldwide representation, hosted by Lygature, an independent not-for-profit organization based in the Netherlands. The working group currently consists of experts from industry, academia, and knowledge institutes, including the Nanotechnology Characterization Lab, the University of Geneva, Lygature, Allergan Plc, and Vifor International Inc.. For more information, please visit www.lygature.org/nbcd.