Antibodies to watch in 2014

Area of Science:

• Biopharmaceutical industry advancements in antibody therapeutics.
• Clinical development and regulatory pathways for monoclonal antibodies.

Background:

• Review of the biopharmaceutical industry's progress since 2010 in advancing antibody therapeutics.
• Focus on transitions to Phase 3 clinical studies, regulatory review, and marketing approvals.

Discussion:

• Anticipated regulatory actions for vedolizumab, siltuximab, and ramucirumab.
• Expected submissions for novel antibody therapeutics including secukinumab, ch14.18, onartuzumab, necitumumab, and gevokizumab.
• Overview of antibody therapeutics in Phase 3 studies, emphasizing 2014 completion dates.

Key Insights:

• Antibodies targeting interleukin-17a/receptor (secukinumab, ixekizumab, brodalumab) are advancing.
• Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors (alirocumab, evolocumab, bococizumab) show promise.
• Programmed death 1 (PD-1) receptor antibodies (lambrolizumab, nivolumab) are in late-stage development.
• Five antibodies with US Food and Drug Administration's (FDA) Breakthrough Therapy designation are highlighted.

Outlook:

• Significant regulatory milestones expected for antibody-based products in 2014.
• Continued progression of antibody therapeutics targeting key disease pathways.
• Potential for new marketing approvals and expanded therapeutic options.