Globally, the number of publicly-disclosed biosimilar development projects has increased over 40% in the last 12 months, new research shows.

Most of these projects have yet to enter clinical development, but the 20% annual increase in the number of biosimilars in clinical trials also indicates substantial advancement in the late-stage pipeline, says the study, from Decision Resources.

South American companies have achieved the biggest increase in the number of biosimilars in development, driven by the large number of Productive Development Partnerships in Brazil between public organisations and industry, the study finds.

Indian companies have disclosed more biosimilar development projects than regional companies located in any other country; however, it remains unclear whether Indian regulators have begun enforcing the 2012 biosimilar guidelines.

Among developers, monoclonal antibodies such as rituximab and trastuzumab are firmly entrenched as the most popular targets, largely due to the high sales captured by the reference brands and the imminent patent expiries in major markets.

And while regulatory guidelines for biosimilars have been adopted in more than 60 countries so far, “we are still a long way from global harmonisation,” says Kate Keeping, group senior director of biosimilars research at Decision Resources.

“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,” she adds. 

Other new research from the firm also reports a 34% rise in partnership activity in the biosimilar space last year, which it says was driven by biosimilar developers recognising the need to augment their internal capabilities with those of an increasing number of market players looking to enter the this space.

The study finds that multiple biosimilar manufacturers are employing novel clinical development strategies such as three-arm Phase I trials, including both US-sourced and European Union (EU)-sourced reference product, to de-risk and streamline their product.

And primary market research suggests that the positive endorsement of early-adopter physicians will be instrumental in differentiating and driving the uptake of a specific biosimilar over competitor products of the same reference molecule.

The high number of partnerships now in place signals the complexity of bringing a biosmilar from the lab to the global market, and the prize for success is a share of sales in the US, Japan, Germany, France, the UK, Italy and Spain which are forecast to exceed $19.5 billion by 2022, says Decision Resources.