FDA Drug Approvals Up in 2018

The US Food and Drug Administration (FDA) accepted 137 New Drug Approvals (NDA) and Biologics License Applications (BLAs) including New Molecular Entities (NMEs) in 2018, representing a 11% increase over the previous year.

GlobalData, a data and analytics company, states the 137 approvals represents an increase over 122 approvals in 2017, as well as a substantial increase from the 101 average FDA approvals from 2012-to-2017.

As seen in the 9^th edition of GlobalData’s pharmaceutical contract manufacturing organization (CMO) industry reporter, “PharmSource—CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance—2019 Edition,” mega cap bio/pharma companies achieved 17 novel approvals in 2018, representing 12% of all NDAs.

Adam Bradbury, associate healthcare analyst at GlobalData, said smaller companies competed in the last 10 years as mega cap-sponsored NMEs remained stable, while outsourcing drug manufacturing.

“Small and mid-cap companies markedly increased their outsourcing of the manufacture of NMEs to CMOs in 2018 compared with the 2013—2017 average,” Bradbury said in a statement.

In total, there were 57 NDAs manufactured by contractors in 2818, with 51% of NMEs outsourced, while 33% of non-NME NDA products were outsourced.

Solid dose NMEs outsources in 2018 represents a 52% share, which is comparable to the average between 2012 and 2017.

However, outsourced injectable approvals increased slightly in 2018 from the previous 5-year average to 44%.

“There were 22 dose CMOs that garnered contracts for NME products in 2018, with Patheon (part of Thermo Fisher Scientific), and Catalent topping the list with 4 and 5 contracts, respectively,” Bradbury said.

The majority of dose manufacturing contracts for new product approvals from CMOs Patheon, Baxter, and Vetter came from large and mega cap companies in the last 10 years. However, Catalent was more dependent in the last decade on mid and small cap companies.

“Although the outsourcing of NME active pharmaceutical ingredient (API) manufacture is highly dependent on the nature of the drug, in general, the outsourcing of small molecule API has remained fairly stable over the last decade, whereas during the same time outsourcing levels have decreased for biologic APIs,” Bradbury said.

Along with the increased approvals in the US, European countries are also witnessing an uptick in new drug approvals.

In 2018, the European Medicines Agency (EMA) approved 48 new active substances (NAS), 14 non-NAS applications, 16 biosimilar, and 11 generic products. The 89 approvals were mainly achieved through a centralized approval pathway process, representing a 20% increase from the 74 approvals per year average in Europe from 2012 to 2017.

It was also a banner year for the FDA in generic drug approvals with 781 in 2018, representing an increase over the 763 generic drugs approved in 2017.

The increase in approvals is part of an overall plan put in place by former FDA Commissioner Scott Gottlieb, MD, who put in place a plan to accelerate the development of generic copies of complex drugs in an effort to give patients better and cheaper access to medicines.