A new report has claimed that “despite the initial regulatory hiccups”, the number of biosimilars that make it to the European market is set to increase gradually.

The analysis, from Frost & Sullivan, notes that patent expiries on big-selling biologics and payers' perception of biosimilars as viable alternatives to originator drugs will further bolster prospects of growth. F&S analyst Sumanth Kambhammettu says that patent expiries of some top-selling biopharmaceuticals “have resulted in a massive market opportunity”.

He argues that drug classes such as erythropoietins, insulin and analogues, granulocyte colony-stimulating factors, human growth hormones and interferons, which have all lost patent protection, had a collective market size of over $34 billion in 2007. These expensive biopharmaceuticals are used primarily for diseases like cancer and diabetes so patent expiries and “an increasing emphasis on cost containment are motivating governments to switch to affordable alternatives”, the report states. Thus, “there exists tremendous growth opportunity for biosimilar manufacturers”.

However, the F&S study acknowledges that “the development of biosimilars is riddled with complexities, ranging from R&D and manufacturing to marketing”. Their development is expensive and the current average cost of bringing a biosimilar to market is around $100-$200 million, in addition to a development period ranging from eight to ten years.

Marketing presents another challenge, says the report “as, typically, there is initial resistance from the physician community”. The most significant challenge, however, “will be in proving similarity with the reference product as per the European Medicine Agency’s standards," notes Mr Kambhammettu.

Pricing will be a key factor, he adds, saying that in doing so, manufacturers must assess factors such as “the nature of the market, product class, level of competition and reimbursement structure". Mr Kambhammettu concludes by saying that as current biosimilars are marketed in the hospital sector, “manufacturers must focus their marketing efforts on specialists to increase the probability of success”. Firms can also increase doctor awareness “by disseminating data pertaining to long-term safety and efficacy of biosimilars”.