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Antibodies to watch in 2015
1a Reichert Biotechnology Consulting LLC ; Framingham , MA USA.
Mabs
|December 9, 2014
Summary
The antibody therapeutics pipeline shows significant growth, with 6 new products approved in 2014 and more expected. Many novel monoclonal antibodies (mAbs) are in late-stage development for various diseases.
Area of Science:
- Biotechnology
- Pharmacology
- Immunology
Background:
- The field of antibody therapeutics is experiencing rapid expansion and innovation.
- Recombinant antibody products are increasingly important in clinical practice.
Purpose of the Study:
- To provide an overview of antibody therapeutics in late-stage development.
- To highlight upcoming approvals and potential market entries in 2014-2015.
Main Methods:
- Review of commercial pipeline data for antibody therapeutics.
- Analysis of regulatory submissions and clinical trial phases (Phase 3).
Main Results:
- Six antibody therapeutics received first marketing approvals in 2014.
- Seven additional antibody therapeutics are under regulatory review.
- 39 novel monoclonal antibodies (mAbs) are in Phase 3, with several expected submissions in late 2014 and 2015.
- Biosimilar infliximab and trastuzumab are also notable for potential market entry and review.
Conclusions:
- The pipeline for antibody therapeutics is robust, with numerous novel agents and biosimilars anticipated in the near future.
- Continued growth in antibody-based treatments is expected across both oncology and non-oncology indications.
Keywords:
BLA, biologics license applicationEMA, European Medicines AgencyEuropean Medicines AgencyFDA, Food and Drug AdministrationFood and Drug AdministrationIV, intravenousMTX, methotrexatePA, protective antigenPCSK9, proprotein convertase subtilisin/kexin type 9RA, rheumatoid arthritisSLE, systemic lupus erythematosusbiosimilar antibodiescancerclinical studiesimmune-mediated disordersinterleukin, ILmAb, monoclonal antibodymonoclonal antibodiespharmacokinetic, PK
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