EPIRUS Strikes Deal With China's Livzon To Develop And Market Biosimilars
American biopharma company EPIRUS has signed a multi-product deal with China-based Livzon to develop, manufacture, and market a series of biosimilars.
EPIRUS’s pipeline includes BOW015 (infliximab), BOW050 (adalimumab), and BOW030 (bevacizumab), biosimilar candidates and alternatives to Remicade, Humira, and Avastin, respectively. EPIRUS estimates that these three biologics generated a $26B market in 2013 alone.
BOW015, an alternative to Remicade, will be EPIRUS and Livzon’s first project. According to the terms of the deal, this collaboration could yield up to five marketable products.
BOW015 is a monoclonal antibody against tumor necrosis factor alpha (TNF-alpha) used to treat autoimmune diseases. Biologic reference Remicade has been approved for the treatment of several diseases including Crohn’s Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, and Plaque Psoriasis.
European clinical studies found that BOW015 performed similarly to Remicade and achieved all endpoints, both in terms of safety and immunogenicity. EPIRUS is actively seeking regulatory approvals in the European market and plans to initiate an additional Phase 3 trial in Europe in 2015.
BOW015 was recently approved in India, and Livzon will conduct necessary studies for the approval of the drug in China and Taiwan. If approved, Livzon will be responsible for marketing the drug in China.
Daotian Fu, CEO of Livzon who also has a seat on EPIRUS’ board of directors, expressed his enthusiasm with EMPIRUS’ pipeline of potential biosmilars. “We look forward to building a substantial biosimilars business for the China market.”
Biosimilars are more affordable drug options that perform similarly to existing brand-name biologics. A relatively new concept, the biosimilar market is set to expand exponentially as patents on leading biologics are set to expire and recent U.S. legislation comes into effect.
IMS Health predicts that the 2015 global market for biosimilars will reach between two and three billion dollars.