Ranbaxy Pharmaceuticals, Inc. (RPI) has launched a generic version of cevimeline, the trade name for which is Evoxac®. The genericwill be marketed in the U.S. under an agreement with Daiichi Sankyo, Inc. RPI is based in Jacksonville, Florida. Cevimeline activates the M3 receptors of the parasympathetic nervous system and leads to increased saliva production. It was FDAapproved in January 2000 for dry mouth, which marked the second therapeutic that has been FDA-approved for a major complication of Sjögren’s.
Actemra® (tocilizumab)Actemra® (tocilizumab) was approved in October 2012 by the FDA for use in rheumatoid arthritis and clinical trials will be launched in Sjoören’s this year. Actemra® is made by Genentech, a member of the Roche group. An interleukin-6 (IL-6) receptor inhibitor, the drug already was approved for use in systemic juvenile idiopathic arthritis. Jacques-Eric Gottenberg,
MD, of Strasbourg, France launched a study this year to investigate the efficacy of Actemra® in Sjögren’s patients.
The most recent company to work on developing a generic version of Rituxan® (rituximab) has run into delays. The South Korean-based company Samsung Electronics has temporarily ceased clinical development of its biosimilar drug. Earlier, Teva Pharmaceutical of Israel also halted development of a biosimilar for the same blockbuster drug. While exact reasons were not provided in either case, experts are on record as saying that the development of a biosimilar appears to be a trickier prospect than expected. Loss of patent protections are looming in both Europe and the U.S. for Rituxan®, which is a B cell-targeted biologic (specifically a chimeric anti-CD20 monoclonal antibody) produced in partnership by Biogen Idec and Genentech/Roche. It is FDA-approved for use in non-Hodgkin’s lymphoma, RA and most recently for Wegener’s granulomatosis and is currently undergoing clinical trials in Sjögren’s.
***This was first printed in the Fall 2012 Sjögren's Quarterly, the SSF medical and scientific newsletter that is distributed free-of-charge to thousands of healthcare providers in rheumatology, ophthalmology, optometry, dentistry and research.