Antibodies to watch in 2018

Area of Science:

• Biotechnology
• Pharmacology
• Immunology

Background:

• Antibody therapeutics development saw accelerated growth in 2017.
• The number of antibody therapeutics receiving first approval in the EU or US reached double digits for the first time.
• This accelerated pace is projected to continue through 2018.

Purpose of the Study:

• To track and summarize antibody therapeutics that received approval in 2017.
• To identify antibody therapeutics currently under regulatory review.
• To forecast potential marketing applications for antibody therapeutics in late-stage clinical studies by the end of 2018.

Main Methods:

• Review of regulatory approvals in the European Union (EU) and United States (US) in 2017.
• Analysis of antibody therapeutics in regulatory review as of December 1, 2017.
• Projection of future marketing applications based on company announcements and clinical study completion dates.

Main Results:

• Ten antibody therapeutics received first approval in the EU or US in 2017.
• Nine antibody therapeutics were under regulatory review, with decisions expected by end of 2018.
• At least 12 additional antibody therapeutics in late-stage studies may submit marketing applications by end of 2018, with 8 for non-cancer and 4 for cancer indications.
• Nineteen more monoclonal antibodies (mAbs) in late-stage studies are also highlighted.

Conclusions:

• The development and approval of antibody therapeutics significantly increased in 2017.
• A substantial number of antibody therapeutics are expected to enter regulatory review and potentially gain marketing approval in 2018.
• The pipeline for both non-cancer and cancer indications remains robust, indicating continued innovation in antibody-based therapies.