CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges

Jan. 4, 2022 – 2021 was a year of many healthcare challenges, but against this backdrop the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 50 novel drugs and its Center for Biologics Evaluation and Research (CBER) approved 10 biological license applications (BLAs) (plus three source plasma products). CDER nearly matched its drug approvals of 2020 (53 approvals) and surpassed the number in 2019 (48 approvals).

A majority of the 2021 approved products are cancer therapies; others were approved to treat such conditions as thermal burns, hepatitis B, tick-born encephalitis, rare diseases, and neurological disorders – including attention-deficit hyperactivity disorder, depression and migraines. The 2021 tally also included the controversial accelerated approval of Aduhelm for Alzheimer’s disease.

Should FDA Commissioner nominee Robert Califf, M.D., be confirmed, the accelerated pathway under which Aduhelm was approved may be revisited. To learn more about what the FDA will look like under Califf, register here for a Jan. 21 CHC webinar (from 12 p.m. to 1 p.m. ET) featuring Nancy Bradish Myers, president, Catalyst Healthcare Consulting.

One of the newly approved BLAs is for Comirnaty, the Pfizer and BioNTech vaccine for COVID-19. Although three COVID-19 vaccines were granted emergency-use authorizations, Comirnaty is the only one that has been approved to date.

Although these approval numbers are good news, they likely would be even better if the FDA could overcome its backlog of manufacturing site inspections. In the agency’s November 2021 “Update to the Resiliency Roadmap for FDA Inspectional Oversight,” the FDA reports that there were new drug application delays as a result of the inspections backlog caused largely by the COVID-19 pandemic.

Domestically, the agency completed more inspections than anticipated in 2021; on the foreign inspection front, the agency focused “primarily on mission-critical inspections in foreign countries,” the update states. Still, by late last year, 52 human drug applications were delayed solely due to a pending inspection or facility assessment, according to the report.

“Given the continuing pressures of the COVID-19 pandemic and the still-significant backlog in manufacturing facility inspections, the high pace of approvals for novel drugs in 2021 was especially remarkable, and testifies to hard work and efficient processes at CDER,” said Coalition for Healthcare Communications Executive Director Jon Bigelow. “The range of products approved demonstrates the potential benefits for patient care and the productivity of the biopharma industry.”

Considering the results for 2021, Bigelow noted, “prospects for 2022 seem strong, especially with some interesting cell and gene therapy products in the pipeline.”