Antibodies to watch in 2021

Area of Science:

• Biotechnology
• Immunology
• Pharmacology

Background:

• The 12th annual review of antibody therapeutics development covers 2020 events and forecasts 2021 trends.
• The COVID-19 pandemic significantly impacted healthcare, accelerating antibody development for SARS-CoV-2.
• Despite challenges, 2020 saw notable approvals and emergency use authorizations for antibody drugs.

Purpose of the Study:

• To summarize key advancements in antibody therapeutics during 2020.
• To forecast potential developments and regulatory approvals for antibody drugs in 2021.
• To highlight the impact of the COVID-19 pandemic on antibody drug development.

Main Methods:

• Review of key events in antibody therapeutics development in 2020.
• Analysis of regulatory approvals and marketing applications in the US and EU.
• Forecasting of potential antibody drug approvals and clinical trial progress for 2021.

Main Results:

• Two anti-SARS-CoV antibody products received emergency use authorization (EUA) by late November 2020.
• Ten antibody therapeutics received their first US or EU approval by November 2020, with more expected.
• 16 investigational antibody therapeutics were under regulatory review by the FDA or EMA for 2021, with 11 for non-cancer and 5 for cancer indications.
• 44 antibody therapeutics were in late-stage clinical studies for non-cancer indications (including 6 for COVID-19) and 44 for cancer indications as of November 2020.

Conclusions:

• The year 2020 marked significant progress in antibody therapeutics, particularly in response to COVID-19.
• A record number of antibody therapeutic approvals are anticipated in 2021, driven by ongoing research and regulatory reviews.
• The pipeline for both cancer and non-cancer antibody therapeutics remains robust, indicating continued innovation in the field.