Antibody therapeutics research and development by the biopharmaceutical industry has undergone remarkable expansion in the past ~ 5 years. Over 100 novel antibodies entered first clinical studies in 2015, and the overall clinical pipeline now includes ~480 antibodies. Importantly for patients, these molecules are progressing through the phases of clinical testing, and being approved for marketing. Over 50 antibody therapeutics for a variety of diseases are in Phase 3 studies. A record number (9 new products) were granted first marketing approvals in the United States or European Union in 2015, and the evidence suggests that a larger number may be approved in 2016. A new presentation now available to Society members shows the number of novel antibodies that entered clinical studies recently, how many are in the three clinical phases, and which antibodies might be approved in 2016. Log in to get the presentation. Not a member? Please join!
‘Antibodies to watch in 2016’ now free
The current late-stage clinical pipeline includes over 50 antibody therapeutics that are listed in the latest installment of the ‘Antibodies to watch’ article series. ‘Antibodies to watch in 2016’ is now freely available on the mAbs website.
mAbs is a journal of the Society, and a special subscription rate of US $63 is available for Society members. To receive the special rate, contact the publisher Taylor & Francis at 1 (800) 354-1420 (Fax: (215) 207-0046) or customerservice@taylorandfrancis.com
The INNs and outs of antibody international nonproprietary names
Recently, the World Health Organization (WHO) introduced new definitions for the assignment of antibody international nonproprietary names (INN). The modifications that already have been effectuated change the way in which therapeutic antibodies are classified as chimeric, humanized and human antibodies. Unfortunately, the new definitions have several major limitations that are unworkable – click here for Paul Carter’s summary.
The Antibody Society intends to represent the Antibody Community at large at an Open Session of the WHO in Geneva on April 12, 2016, and request urgent modifications that address the problems with the new system. To be able to influence the WHO, we need your support. You can support our effort by agreeing to the statement here and provide your name and information.
Antibodies to watch in 2016
Seven novel antibody therapeutics (begelomab, bezlotoxumab, brodalumab, ixekizumab, obiltoxaximab, sarilumab, reslizumab) are undergoing regulatory review as of December 2015, and thus may gain their first approvals in 2016. Commercial late-stage antibody therapeutics development has exceeded expectations by increasing from 39 candidates in Phase 3 studies as of late 2014 to over 50 as of late 2015. Of these candidates, transitions to regulatory review by the end of 2016 are projected for 8 (atezolizumab, benralizumab, bimagrumab, durvalumab, inotuzumab ozogamicin, lebrikizumab, ocrelizumab, tremelimumab). Other “antibodies to watch” include 15 candidates (bavituximab, bococizumab, dupilumab, fasinumab, fulranumab, gevokizumab, guselkumab, ibalizumab, LY2951742, onartuzumab, REGN2222, roledumab, romosozumab, sirukumab, Xilonix) undergoing evaluation in Phase 3 studies that have estimated primary completion dates in 2016. As evidenced by these therapeutics, the biopharmaceutical industry has a highly active late-stage clinical pipeline that may deliver numerous new products to the global market in the near future.
2015: An extraordinary year for first marketing approvals of antibody therapeutics
The number of novel antibody therapeutics that received a first marketing approval in 2015 exceeded expectations, with 8 (alirocumab (Praluent®), elotuzumab (Empliciti®), evolocumab (Repatha®), daratumumab (Darzalex®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®), necitumumab (Portrazza)) granted their first approval as of late December. A total of 9 antibody therapeutics were granted a first US approval in 2015, including all 8 antibodies noted above as well as secukinumab (Cosentyx®), which received a first approval in Japan in 2014. In the European Union, the European Commission also granted marketing approvals to 9 antibody therapeutics in 2015, including 5 antibodies noted above ((alirocumab (Praluent®), evolocumab (Repatha®), dinutuximab (Unituxin®), idarucizumab (Praxbind®), mepolizumab (Nucala®)) and 4 products that had been previously approved in another country. A table of therapeutic monoclonal antibodies approved or in review in the European Union or the United States can be found in the Members Only section of The Antibody Society’s website.
