Antibodies to watch in 2017

Area of Science:

• Biotechnology
• Pharmacology
• Clinical Medicine

Background:

• The pipeline for monoclonal antibody (mAb) therapeutics is robust, with over 50 agents in late-stage clinical development.
• Regulatory agencies in the US and EU have shown a consistent trend of approving multiple new mAbs annually since 2014.
• Recent approvals in 2016 and anticipated approvals in 2017 highlight the dynamic nature of mAb development.

Purpose of the Study:

• To analyze the current landscape of investigational monoclonal antibody (mAb) therapeutics in late-stage clinical studies.
• To project the near-term trend of first marketing approvals for mAbs in the US and European Union (EU).
• To identify key mAbs expected to receive regulatory approval in 2017 and beyond, including those for oncology and non-oncology indications.

Main Methods:

• Review of regulatory approval data for monoclonal antibodies (mAbs) in the US and EU from 2014 to December 2016.
• Analysis of company announcements regarding regulatory submission plans and estimated completion dates for late-stage clinical studies.
• Categorization of mAbs in pivotal studies by therapeutic area (cancer and non-cancer indications) with projected submission timelines.

Main Results:

• Six mAbs received first approvals in 2016 in the US or EU, with Brodalumab approved in Japan.
• At least nine new mAbs are anticipated for first approval in the US or EU in 2017.
• Marketing applications for at least six additional mAbs are expected by late 2016 or 2017, with 20 more in pivotal studies for 2017/2018 submissions.

Conclusions:

• The field of monoclonal antibody (mAb) therapeutics is experiencing significant growth, with a high volume of drugs in late-stage development.
• A sustained rate of 6-9 first-time marketing approvals per year is projected in the near term.
• The ongoing clinical evaluation of numerous mAbs suggests a continued expansion of treatment options for both cancer and non-cancer diseases in the coming years.