The GRx-Biosims 2019 meeting started off with a meditation and stretching exercise; after that, we had to put our minds to work and begin exercising out neurons.  Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs, provided an update on generic drug activity, action plans, and biosimilars.  Key points and highlights were:

  • Record breaking number of ANDA approvals in FY 2019 (935)
  • 125 first-time generic approvals
  • 138 approvals for complex generics
  • 205 product-specific guidances
  • The use of the Mutual Recognition Agreement with the EU on inspections designed to keep regulatory authorities from duplicating inspectional efforts
  • FDA has approved twenty-three biosimilars
  • However, only nine of those twenty-three products have launched
  • Cost savings from generics and biosimilars provide incredible cost savings

Chip Davis, President and CEO of the Association of Accessible Medicines, spoke to the following issues:

  • 90% of prescription are filled with generic drugs but they only account for 22% of the total drug spend.
  • Average co-pays for generics are $5.63 versus $40.65 for brand name drugs.
  • The industry needs to address the attack on generic drug quality.
  • Only half of all first generic approvals launched in the fiscal year.
  • The delay of first generic approvals onto Medicare Part D and formularies is costing consumers and the government over $4 billion a year as many of the first generics are being placed on brand-tier copays.
  • Specialty generic equivalents for specialty brand drugs should be placed on generic tiers rather than on brand tiers.

An interesting start to the meeting and we will try to keep you updated on the sessions we attend and exciting issues of which we become aware.