OR WAIT null SECS
Looking back at the biologics and large molecule drugs approved by FDA in the past year can give us hints toward what will be approved in the future.
When attempting to gauge the future of emerging therapies, it’s important to also look to the past for clues on what may be lurking beyond the horizon. Knowledge of what FDA has approved in the past is instrumental not only in understanding the current regulatory landscape, but also in determining the types of therapies that are likely to be approved going forward.
Of the 16 novel molecular entities and therapeutic biological products that have been approved by FDA in 2022 at the time of this article’s writing, the three discussed in this article are all but one of the biologics (1). While this is a significant decrease from 2021, which saw four biologics approved in November and December alone, it is notable that novel approvals as a whole are down significantly; at this time last year, there were 35 total approvals (i.e. both new drug applications and biologic license applications) approved (2).
While there are many reasons why such a decrease can occur, including simple random chance, it nonetheless places greater emphasis on what therapies are getting through the approvals process. Examining the biologics that are getting through could provide a baseline for the requirements needed to get through future approval processes.
Grant Playter is the Assistant Editor for Pharmaceutical Technology, BioPharm International, and Pharmaceutical Technology Europe.
eBook: Emerging Therapies 2022
When referring to this article, please cite it as G. Playter, "Novel Therapies of 2022," BioPharm International’s Emerging Therapies 2022 eBook (September 2022).