Antibodies to watch in 2023

Area of Science:

• Biotechnology
• Immunology
• Pharmacology

Background:

• The annual review of monoclonal antibody (mAb) therapeutics development tracks significant commercial advancements.
• 2022 marked a dynamic period with multiple new approvals and a growing late-stage pipeline.

Purpose of the Study:

• To summarize key commercial monoclonal antibody therapeutics development events in 2022.
• To forecast potential developments and approvals for 2023.

Main Methods:

• Analysis of regulatory approval data from the United States and European Union up to mid-November 2022.
• Review of global regulatory submissions and late-stage clinical pipeline growth, excluding COVID-19 specific antibodies.

Main Results:

• Twelve antibody therapeutics received first-time approvals in the US or EU in 2022, including four bispecific antibodies and one antibody-drug conjugate (ADC).
• Seven additional antibody therapeutics were approved in China or Japan in 2022, including two bispecific antibodies.
• Globally, 24 investigational antibody therapeutics were under regulatory review as of mid-November 2022.
• The late-stage commercial clinical pipeline (excluding COVID-19) expanded by approximately 20% to nearly 140 candidates.
• At least 23 marketing applications are anticipated by the end of 2023, including five bispecific antibodies and two ADCs.

Conclusions:

• The field of monoclonal antibody therapeutics continues to expand rapidly, with diverse formats and engineering techniques.
• The increasing number of approvals and robust late-stage pipeline suggest continued innovation and therapeutic advancements in the coming year.