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Antibodies to watch in 2016
1a Managing Director, Reichert Biotechnology Consulting LLC , Framingham , MA , 01701.
The number of novel antibody therapeutics approved in 2015 met expectations. A robust late-stage pipeline suggests numerous new antibody products will reach the market soon.
Area of Science:
- Biopharmaceutical industry
- Antibody therapeutics development
- Clinical pipeline analysis
Background:
- In 2015, six novel antibody therapeutics received marketing approval, meeting expectations.
- The late-stage antibody development pipeline expanded significantly from 2014 to 2015.
Purpose of the Study:
- To analyze the landscape of novel antibody therapeutics.
- To project future approvals and market entry of antibody drugs.
Main Methods:
- Review of marketing approvals granted in 2015.
- Analysis of antibody therapeutics in regulatory review and Phase 3 studies.
- Projection of regulatory transitions and Phase 3 completion dates.
Main Results:
- Six novel antibody therapeutics were approved in 2015.
- 53 antibody candidates were in Phase 3 studies by late 2015, with 8 projected for regulatory review in 2016.
- 15 additional antibody candidates are in Phase 3 with 2016 completion dates.
Conclusions:
- The biopharmaceutical industry exhibits a highly active late-stage clinical pipeline for antibody therapeutics.
- Numerous new antibody products are anticipated for global market release in the near future.
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