Clover filed IND with CFDA for SCB-808, a ready-for-injection biosimilar of blockbuster anti-TNF biologic, Enbrel (etanercept)

CHENGDU, CHINA, November 13, 2015 — Clover has completed IND filing with the CFDA for SCB-808, a biosimilar of blockbuster anti-TNF biologic, Enbrel (etanercept).  SCB-808 is being developed as a ready-for-injection formulation in a prefilled syringe.  Currently available etanercept biosimilars in China are only approved as lyophilized powder preparations that must be reconstituted before injection.   Enbrel is currently used as the leading biologic treatment for Rheumatoid Arthritis (RA) and is also used to treat Plaque Psoriasis (PsO), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA) and Polyarticular Juvenile Idiopathic Arthritis (JIA).  Worldwide-sales of Enbrel reached approximately $9 billion USD in 2014.  The first indication SCB-808 is being developed for in China is Rheumatoid Arthritis.