While the majority of these development projects are not yet in clinical development, the 20% annual increase in the number of biosimilars in clinical trials indicates significant advancement in the late-stage pipeline, according to DRG.
Key findings from the report show that much of this growth is attributed to the large number of Brazilian Productive Development Partnerships with South American companies to bring biosimilar manufacturing into the country.
Also, Indian companies have disclosed more biosimilar development projects than regional companies located in any other country, but these projects are subject to enforcement of the 2012 biosimilars guidelines by Indian regulators.
The most popular targets, according to the report, are monoclonal antibodies, such as rituximab and trastuzumab, based on high sales of the reference brands and imminent patent expiries.
Despite the recent growth in biosimilar development, regulatory challenges persist. Although guidelines for biosimilars have been adopted in more than 60 countries, global harmonization of requirements for approval have not been established.
Kate Keeping, Decision Resources Group’s senior director of Biosimilars Research, said, "The rapid expansion of the biosimilar development pipeline shows that there is no sign of the commercial threat from biosimilars going away for innovator companies. However, the remarkable speed of pipeline growth will be better news for over-stretched healthcare budgets that urgently need more affordable biologic medicines."
She added, "Biosimilar manufacturers face many challenges, such as upfront manufacturing costs, demonstrating biosimilarity, designing clinical trials to meet ever-changing regulations, assuaging physician concerns about comparability to the original brand, and product differentiation. We are still a long way from global harmonization, so it is critical to understand the regional differences within the competitive and regulatory landscape."