1. Figure 3. BLA and NME Drugs Sponsored by US companies (1980-2014)
The objective of this study was to assess trends in approvals of new molecular entities (NME) and new therapeutic biologic license applications (BLA) in the US in the period by country of incorporation of the first sponsor company of the application. .
Tracking the Sponsoring Country of Incorporation for New Drugs Approved by the US FDA in the Period : A Trend Analysis
Saad Alqahtani,1 Rosa Rodriguez-Monguio,2 Enrique Seoane-Vazquez,1,3 Tewodros Eguale,1,3 Minette-Joelle Zeukeng,4 Sheryl L. Szeinbach5
1. International Center of Pharmaceutical Economics & Policy, MCPHS University, Boston, MA School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA Brigham Women's Hospital, Boston, MA University of Geneva, School of Pharmaceutical Sciences Ohio State University, College of Pharmacy, Columbus, Ohio
Background
Objectives
The pharmaceutical industry reached a substantial level of globalization and convergence in the regulation of pharmaceuticals in the 90s. However, only a few countries produce most the pharmaceutical innovation in the world.
The US is the largest pharmaceutical market by dollar sales in the world and approval in the US is often one of the main market priorities of global pharmaceutical companies. The high degree of globalization of the pharmaceutical industry has also created pressure for the international regulatory harmonization of pharmaceuticals, often following the lead of the US FDA. The US FDA has high regulatory standards and approval by the US FDA is a positive factor for consideration for approval for other regulatory agencies. There is a lack of recent studies assessing the country of incorporation new drugs.
Methods
Regulatory information for NMEs and BLA approved in the study period was derived from the FDA, and the country of incorporation of the sponsor companies at the date of drug approval was extracted from Lexis- Nexis, companies’ webpages and financial reports. Drugs were classified using the anatomical therapeutic chemical classification from the WHO. Descriptive statistics and chi-square tests were conducted in the study.
Results
Figure 1. FDA Approvals by Sponsor’s Country of Incorporation as a % of Total FDA Approvals ( )
Figure 2. Trends in FDA Approvals by Sponsors Incorporated in the US ( )
% Approvals
Time Period
Figure 3. BLA and NME Drugs Sponsored by US companies ( )
Figure 4. Orphan and non-orphan Drugs Sponsored by US companies ( )
% Approvals
% Approvals
p < 0.001
The FDA approved 103 BLA and 866 NME during the period Five countries had an average of at least 1 BLA/NME approved per year during the study period: US (57.9% of all approvals), UK (10.6%), Switzerland (10.0%), Germany (7.1%), and Japan (3.7%).
The percentage of drugs approved by US companies ranged from 65.9% for antiinfectives for systemic use to 38.9% for sensory organs.
US companies sponsored a higher number of BLA (76.7%) than NME (55.7%) (p<0.001).
The percentage of drugs approved by US companies varied from 62.7% in the 1980s, 56.6% in the 1990s, 58.2% in the 2000s, and 53.2% in the period
US companies sponsored a larger percentage of orphan (64.8%) than non-orphan drugs (54.6%) (p<0.001).
The therapeutic classes with the largest percentage of approvals for each country of incorporation were: dermatologicals in the UK (27.0% of all approvals), sensory organs in Switzerland (38.9%), respiratory system in Germany (18.4%), nervous system in Japan (9.4%), and genitourinary system and sex hormones in France (6.1%).
Pharmaceutical companies often enter in licensing agreements with universities, public organization and other companies making in difficult to assess the origin of the innovation.
Conclusions
Approximately 90% of all new drugs approved by the FDA were sponsored by companies incorporated in US, UK, Switzerland, Germany, and Japan, indicating the concentration of pharmaceutical R&D in a few countries.