Biosimilars: the challenges to bring a “new” concept to market A short review of the first decade of biosimilars
Biosimilars have had marketing approval in Europe for a decade. Despite initial concerns that such a class of drugs carried inherent risks to patients – these 10 years have been a medical success. All EMA approved biosimilars have been found equally safe and effective as their reference products.
The clear pharmaceutical and clinical success of biosimilars over the decade stands in stark contrast to their commercial performance. Uptake within Europe has varied between 2 and 100%. No other class of drug shows such striking variation. Understanding why such a scientific success can be such a commercial worry is important both to manufacturers and health system payers. The failure to create a functioning global biosimilars market will starve investment needed for next generation biosimilar development. At the same time it could wipe out the predicted savings that payers have been banking on to keep healthcare sustainable.
The evolution of the “biosimilar” regulatory pathway is a scientific success for its pioneers at the European Medicines Agency (EMA) (1). Omnitrope® a recombinant human somatropin, as an example received approval April 12th 2006. At this tim ...