The State of Monoclonal Antibodies in Medicine Today

Once again, the journal mAbs has published its 11th annual “Antibodies to Watch” article as an overview of exciting antibody products staged for significant advances in the coming year, authored by Hélène Kaplon, Mrinalini Muralidharan, Zita Schneider and Janice M. Reichert. The authors review data of antibodies approved in the US, EU, Russia and India in 2019, and they describe, in great detail, updates and anticipated events in clinical development for 2020.

They also provide summaries on antibody therapeutics currently in late-stage clinical study that are likely to progress to regulatory review in 2020. Five novel antibody therapeutics gained first approval in 2019 including romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, and crizanlizumab. Marketing applications for thirteen novel antibody therapeutics (eptinezumab, teprotumumab, enfortumab vedotin, isatuximab, [fam-]trastuzumab deruxtecan, inebilizumab, leronlimab, sacituzumab govitecan, satralizumab, narsoplimab, tafasitamab, REGNEB3 and naxituximab) are expected to be submitted to FDA in 2020. Beyond these products staged for approval, there are 79 antibodies in late-stage clinical studies, of which 39 are intended for non-cancer and 40 for cancer indications. The article reports on a robust late-stage clinical pipeline with substantial growth made since 2010.

We encourage readers to peruse the article, in particular for the detailed tables with information on the numerous antibodies. To read the article, please refer to: Hélène Kaplon, Mrinalini Muralidharan, Zita Schneider and Janice M. Reichert (2019). Antibodies to watch in 2020. mAbs.

Chamow & Associates assists companies to develop biologics for clinical testing and welcomes your inquiry.

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Steven M. Chamow, Ph.D., Principal Consultant |
San Mateo, CA
© 2020 Chamow & Associates |