Each year, many scientists and other experts working in the biopharma industry see years of their work culminate in FDA approvals. With the COVID-19 crisis stretching into its third year, the 2021 batch of new drug approvals clearly demonstrates that the sector has learned how to operate in a pandemic.
All told, the industry nabbed 55 FDA approvals in 2021. They include the controversial accelerated approval for Biogen's Alzheimer's drug Aduhelm, Pfizer's record-shattering COVID-19 vaccine, Comirnaty, and many others.
Not all 2021 approvals commanded as many headlines as Aduhelm and Comirnaty. Aside from those notable companies, also represented in 2021's crop of new approvals were Amgen, Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Regeneron.
And among the dozens of new drugs green-lit last year, companies such as BridgeBio, ChemoCentryx and Apellis won their first-ever FDA approvals, setting them up to make their commercial debuts.
Yet, some applications did face pandemic challenges. The FDA struggled to keep up with its inspection duties during the pandemic, leading to regulatory delays for certain drugmakers. In November, the agency reported that 55 new drug applications were facing inspection delays. Avadel Pharmaceuticals and UCB were among those to experience inspection-related delays in 2021.
How does last year's class of new drug approvals compare to prior years? In 2020, the industry notched 55 approvals for new molecular entities, up from 48 in 2019 but down from 58 in 2018. The numbers for our annual roundup typically vary slightly from the FDA's official list, because our report includes approvals for notable biologics such as vaccines and cell therapies. We also exclude diagnostic imaging agents, which are represented on the FDA's list.
Importantly, this report only includes full FDA approvals, so COVID-19 vaccines from Moderna and Johnson & Johnson—as well as the antibodies from Regeneron, Eli Lilly and GlaxoSmithKline—didn't make the cut. Those products won Emergency Use Authorizations for deployment in response to the pandemic. That's not to discount the major impact those products have had in the ongoing COVID fight, and the significant revenues they have brought to their makers.
We hope you enjoy reading about the 2021 class of new drug approvals and we hope you stick with us throughout 2022 as we cover the industry's continued evolution.