The COVID-19 pandemic is driving an increase in novel FDA approvals and outsourcing of manufacturing

Innovative drug approvals increasein the US between 2019 and 2020. This increase happened despite the FDA’s stretched resources, as it had to reassign staff to cope with COVID-19-related activities. The agency approved 121 novel drugs in 2020, compared with 119 in in 2019, says GlobalData, a leading data and analytics company.

Adam Bradbury, PharmSource Analyst at GlobalData comments: “There was a large increase in approvals of new molecular entities (NMEs), the most innovative drug type with 21% more NME approvals than in 2019. There were also more small cap pharma–sponsored drug approvals and overall approvals compared with 2019. This is a positive sign for contract manufacturing organizations (CMOs), as small cap pharma companies tend to heavily outsource manufacturing.”

This increased approval count does not include Emergency Use Authorizations (EUAs) for COVID-19, such as Pfizer and BioNTech’s COVID-19 vaccine. Emergency approvals for COVID-19 were even more highly outsourced due to the scale of production and compressed development timelines.

Bradbury continues: “Even large pharma companies outsourced complex manufacturing in 2020, such as Gilead Sciences with its Trodelvy, a monoclonal antibody conjugated requiring containment. Trodelvy has both its API and dose production outsourced to CMOs.”

For 2020 approvalsthe propensity to outsource the dose manufacture of NMEs and non-NME NDAs increased by 4%. For NMEs, approvals remained strong, although lower than in 2017 and 2018.

Bradbury concludes: “NMEs are the most innovative and challenging drugs to develop and manufacture, and many small pharma company drug sponsors lack the capabilities to manufacture theand must outsource their production.”

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