In terms of revenue, six of the top ten pharmaceutical therapies are biological products, which have been targeted by biosimilar developers: AbbVie's Humira (adalimumab), Roche's MabThera (rituxan), Herceptin (trastuzumab) and Avastin (bevacizumab), Sanofi's Lantus (insulin glargine), and Johnson & Johnson's Remicade (infliximab). These products had combined global sales of US$41.4 billion in
2012. Also of significant importance to biosimilar developers but just outside the top ten with sales of US$4.2 billion in 2012 is Amgen's Enbrei (etanercept).
The EU market is on the verge of a new generation of biosimilars, following announcements from Celltrion and Hospira at the end of June 2013 that the European Medicines Agency's Committee for Medical Products for Human Use has issued a positive opinion for the first biosimilar infliximab for the treatment of rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. Celltrion has already received market approval for its infliximab biosimilar in South Korea, under the brand name Remsima.Hospira intends to market the product as lnflectra, following final approval. lnflectra/Remsima is the first monoclonal antibody (mAb) therapy to reach a positive opinion following review via the EMA biosimilars regulatory pathway and represents an important milestone for a new era of lower-cost biological therapies in Europe.
Thus far, the biosimilar market has been largely reliant on three products: somatropin; erythropoietin, also known as epoetin or EPO; and human granulocyte colony stimulating factor (G-CSF, filgrastim). Numerous versions of these products are available in semi-regulated markets around the world. In the EU, fourteen biosimilar products currently have marketing authorisation. Other highly regulated markets with biosimilars approved include Australia, Canada and Japan. In the USA, the long drawn out process toward biosimilar regulation has kept this market out of reach. However, as US legislation comes into...