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# High Pace of Biotech Approvals Seen to Continue
- URL: https://www.fdaweb.com/high-pace-of-biotech-approvals-seen-to-continue/
- Published: 2017-05-09T12:00:00.000Z
- Updated: 2026-09-14T22:22:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138643

The Tufts Center for the Study of Drug Development says that FDA approved more than 300 biotech products covering 267 indications from 1980 through 2016, or about 35% of all new drug approvals. The center’s latest [Impact Report](http://csdd.tufts.edu/reports/description/ir%5Fsummaries?ref=fdaweb.com) (subscription or purchase required) says that given the historically high Phase 3-to-approval success rate of biologicals in late-stage development (74%), the extensive biotech product pipeline of 429 candidates in Phase 3 trials at the end of 2016 suggests that the high pace of biotech product approvals will continue through the next decade.

In the period 2000-2016, the report says, FDA approved 225 new biotech products, compared to 304 small-molecule drug approvals in the same period. New oncology products accounted for 20% of that total.

Monoclonal antibodies were the largest product category in Phase 3 trials, the report says, accounting for 34.5% of 429 biotech products. Development of biosimilars also expanded rapidly, accounting for more than 60 products in Phase 3 in 2016\. Tufts says that biosimilars are being developed for 19 different marketed products, nine of which focus on monoclonal antibodies.

Products being developed to treat oncology indications accounted for 34% of all biotech products in Phase 3 trials in 2016, the report says. Seven other disease areas — rheumatology, infectious diseases, endocrinology, ophthalmology, neurology, and dermatology — each with 20 or more products in development, accounted for 47% of all biotech products in Phase 3 trials in 2016.