GENERIC COMPETITION IN THE US (1980-2016)

OBJECTIVES: This study assessed trends in generic drugs approved by the US FDA in the period 1980-2016. METHODS: Study data were derived from the FDA webpage. We assessed the first generic entry for new molecular entities (NMEs) and new therapeutic biologic license applications (BLAs) approved during the study period. We estimated the time from BLA/NME approval to biosimilar/generic approval. Descriptive analysis, t-test and Chi-Square where used in the analysis. Stata 13.1 was used for the analysis. RESULTS: The FDA approved 1033 new drugs in the period 1980-2016 including 914 NMEs and 119 BLAs. Nine BLAs and 137 NMEs were discontinued from the market as of December 31, 2016. There were 4 BLAs that experienced biosimilar competition. There were 156 (15.1%) NMEs discontinued from the market and 249 (23.5%) that had patent or exclusivity listed by the FDA, resulting in 528 NMEs that candidates to generic competition of which 392 (74.2%) experienced generic competition during the period of analysis. There were 312 (78.0%) non-orphan NMEs and 91 (49.5%) of orphan NMEs with generic competition. The BLAs with biosimilar competition had a period of single source of 18.3±4.26 years. The NMEs with generic competition had a period of single source of 13.3 ±4.3 years. The single source period of NMEs was 13.5 years in 1980-1984,13.8 years in 1985-1989,12.3 years in 1990-1994, and 11.9 in 1995-1999. Data for the period 2000-2016 is right censored as drugs are expected to experience generic competition in the future. CONCLUSIONS: Only a small number of BLA experienced biosimilar competition due to the recent implementation of a pathway for biosimilar approval. A significant number of drugs, especially orphan drugs did not experience generic competition in spite of having not patent or exclusivity protection. The single source period of NMEs declined over time.