Antibodies to watch in 2020

Area of Science:

• Biopharmaceutical development
• Antibody therapeutics
• Clinical research

Background:

• The 'Antibodies to Watch' series tracks antibody therapeutics approved or in development.
• 2019 marked significant activity in antibody approvals and regulatory reviews.
• The biopharmaceutical industry's pipeline is crucial for future patient treatments.

Purpose of the Study:

• To document antibody therapeutics approved in 2019.
• To identify antibody therapeutics in regulatory review in the US and EU.
• To survey novel antibodies in late-stage clinical studies as of November 2019.

Main Methods:

• Review of regulatory approvals in the United States and European Union.
• Analysis of marketing applications under review in major markets.
• Survey of novel antibodies in late-stage clinical trials (Phase 3).

Main Results:

• Six novel antibody therapeutics received first approval in 2019.
• Thirteen novel antibody therapeutics were under regulatory review.
• Seventy-nine novel antibodies were in late-stage clinical studies, with 40 for cancer and 39 for non-cancer indications.

Conclusions:

• The clinical pipeline for antibody therapeutics is robust.
• Continued innovation in antibody therapies is expected.
• Future supply of innovative antibody products for patients is anticipated.