Biosimilars can be considered a controversial subject because of safety concerns related to immunogenicity. Despite this, the biosimilars industry seems to be booming. Recent research from industry analysts Datamonitor estimated that the value of the global market for biosimilars would jump from $243 million in 2010 to $3.7 billion in 2015, and the biosimilars have now been used safely for 5 years, according to the European Generic Medicines Association (EGA).

But there are still hurdles that the industry must overcome. At its international symposium on biosimilar medicines held earlier this week in London (UK), the EGA issued a call for an EU industrial policy that will enhance the competitiveness of the region’s biosimilar medicines industry.

In a press statement about the symposium, Greg Perry, EGA Director General, explained that new, smart approaches are required to further develop and sustain the EU’s biosimilars industry. “The regulatory framework should be adapted to allow and accept global development programmes for biosimilars in order to ensure the availability and affordability of this important category of medicines”.

According to the EGA, it is also important to promote the EU’s high standards for biosimilars across the rest of the world and to boost uptake. Perry emphasised: “We need incentives for the demand-side, a consistent rational approach towards interchangeability, acceptance of different cost-price structures than for generic medicines, and an increase of awareness and information aimed at reinforcing the confidence of patients and healthcare professionals in these high quality biopharmaceuticals.”