Remicade's approval in Europe for the improvement of physical function in rheumatoid arthritis patients looks set to create a far more balanced market share with its main competitor, Enbrel. But with new alternatives emerging in the arthritis arena, both may ultimately struggle to maintain position.
Schering-Plough and Centocor's Remicade (infliximab) was approved, in combination with methotrexate, for the treatment of the signs and symptoms of rheumatoid arthritis (RA) in June 2000 following the successful completion of clinical trials. However, this indication limited the use of Remicade in the EU to the treatment of early stage RA and as such limited the patient population available for treatment. The new indication opens up the RA market to Remicade and will allow the drug to compete more favorably with other RA drugs, in particular Wyeth-Ayerst's Enbrel (etanercept).
Remicade and Enbrel have similar modes of action, targeting the inflammatory cytokine tumor necrosis factor alpha (TNF-alpha) and look set to be major players in the RA market over the coming years. However Enbrel currently leads its competitor, following earlier approval for the treatment of RA in both the US and the EU and this first-to-market advantage has been enhanced by the more favorable indication granted to Enbrel.
The newly granted EU authorization for Remicade looks set to level the playing field, bringing competition down to two main factors, cost and delivery. As both drugs are expensive therapies, the choice between weekly subcutaneous injections (Enbrel) or monthly infusions (Remicade) could be the key to market success.
While Enbrel is expected to maintain a lead in the EU market based on its earlier approval, Remicade is expected to make up significant ground based on its new authorization. However, both drugs need to secure their market share, as the RA market is expected to become extremely competitive in the coming years. With up to 25 potential launches into this market, of which six are TNF-alpha blockade drugs, both Enbrel and Remicade will face intensive competition and the prospect of losing market share.