The First Biopharmaceuticals Approved in the United States: 1980-1994

Abstract

Over the last 15 years, the United States biotech industry has developed innovative biopharmaceuticals through clinical application of recent technical advances in molecular biology. In an effort to study the impact of these new technologies on drug development, data were gathered on the first approval of biopharmaceuticals in the United States during 1980-1994 via company surveys and public access sources. These new biologic entities (NBEs, n = 29) consist of recombinant proteins, therapeutic and diagnostic monoclonal antibodies, a recombinant vaccine, and purified nonrecombinant proteins. The means for the three development phase lengths for these novel NBEs were 40.1 months for the clinical phase (time from investigational new drug [IND] filing to product license application [PLA] submission, n = 28), 22.6 months for the regulatory review phase (time from PLA submission to approval, n = 29), and 61.0 months for the total development phase (clinical and regulatory review phase, n = 28). Taken together, the mean total development time for the NBEs was 38.9 months shorter than that for the new chemical entities (NCEs, n = 303) approved during the same 15-year period.

The NBEs' development phase lengths are further described by therapeutic category, whether the NBE received orphan drug status and/or expedited review at the Food and Drug Administration (FDA), and country of first approval. The 29 NBEs are also subdivided into four categories in order to compare the development phase lengths within the total NBE group: 1. New recombinant entities (NREs, n = 10), recombinant proteins not previously tested in humans, 2. New recombinant versions (NRVs, n = 6), recombinant proteins whose purified, nonrecombinant counterparts have a history of prior human use, 3. Monoclonal antibodies (n = 3), and 4. Nonrecombinant proteins (BIOs, n = 10). Notably, the NRVs' mean total development phase length was 20.9 months and 59.8 months shorter than that for all the NBEs and NCEs, respectively, approved during 1980-1994. Lastly, the development times for the NBEs approved in the 1980s versus those approved in the 1990s are compared.

Keywords

Biopharmaceuticals Approval Development phase Orphan drug New biologic entities

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