Biosimilars in the Americas: the future by consensus

Excerpt

The development of biologic agents, proteins engineered to specifically target key components of the inflammatory pathway, heralded a new era in the management of rheumatic diseases. With impressively high efficacy, especially in combination with methotrexate, they have lowered mortality [1] and raised the bar for supressing disease activity in rheumatoid arthritis (RA) so that induction and maintenance of remission is now realistic for many patients – something that would have been unheard of some decades ago [2]. However, despite their undoubted efficacy, the high pricing of these drugs, driven partly by the need for expensive biosynthetic manufacturing plants and partly by the ability of rich countries to pay, resulted in an inequitable usage world-wide. Health care organisations in richer, developed countries, paid the premium prices requested by Industry. Yet even many rich countries limited biologics use, requiring some level of co-payment, or limiting funding to the more severe forms of disease (such as the UK, where reimbursement for biologics in RA only occurs if DAS 28 > 5.1). If rich countries experienced a struggle to provide ready access of these important drugs, what chance did developing countries have? …