The current situation and future prospects for biosimilars is similar to that of small molecule drugs, according to an analysis by Research and Markets: they get to benefit from patent expiry. On this basis, prospects for biosimilars might look good, with the vast majority of leading originator brands in the global biologics market expected to lose some degree of protection by 2019.
But even though that is on the horizon and all major countries also now make provision for what they consider an abbreviated biosimilar development and regulatory pathway, the reality has been different. The industry had projected biosimilar sales of $16+ billion in the EU and US alone for 2011 but that estimate turned out to be 50 times too high. Publication of the long-awaited guidance on the US Biologics Price Competition and Innovation Act could mean a new dawn for biosimilars or another false one. Generally speaking, governments always think they are helping by creating a lot of new rules that hamper creativity and development.
The new analysis details the situation in 27 developed and developing countries - across Europe, the Americas, Asia-Pacific and the Indian subcontinent and discusses where and with which biosimilars the most and least success has been achieved, and why.
It also discusses the complexities of biological patents and the big controversies with biosimilars : Sourcing of reference products, similarity, naming, interchangeability, immunogenicity, traceability, indication extrapolation. Despite the barriers that have held the market back, the regulatory issues are not the only issue. The report also discusses patents/data exclusivity via development, manufacturing issues, pricing and reimbursement demands, funding provisions and the realities of the market.