In a new report, entitled ‘Improving Patient Recruitment in Biosimilar Trials’, the research group quizzed 103 clinical investigators about patient involvement in research and found that 97 per cent believe the chance of participating in a biosimilar study and “gaining access to an approved product their insurance does not reimburse for” could motivate people to take part.
A further 72 per cent of the respondents indicated they would also be “very excited” if a biosimilar protocol landed on their desk.
However, the results were only found after ISR defined the term 'biosimilar' for the 50 per cent of respondents who said they were “unfamiliar” with it before participating in the analysis.
The report surmised that a lack of understanding about the subject is hindering patient recruitment in the area.
President of Industry Standard Research (ISR) Andrew Schafer, told Outsourcing-Pharma.com that previously “cloudy” regulations on the subject is a key reason for the confusion.
“It is not really a common term, especially in the United States where the regulatory pathway is still a bit clouded.”
The FDA definition of 'biosimilar': A biosimilar is a biological product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. - from gabionline.net
Education will boost recruitment
Schafer stressed that site staff training is the key to removing the confusion and any negative impact on patient recruitment.
“I would start with an education program aimed at investigative sites that outlines what a biosimilar trial is, how it is expected to be different from a ‘traditional’ study and then translate and outline the benefits and drawback from the patient perspective.”
He also called upon industry bodies – including the Pharmaceutical Manufacturers’ Association (PhRMA), the Association of Clinical Research Organisations (ACRO), and the Drug Information Association (DIA) – to do their part by discussing the problems and releasing more solutions.
“Biosimilar trials can be quite complex depending on the inclusion or exclusion criteria, recent success or failure with other treatment regimens, access to a reference product, and whether the sponsor has designed the trial for a biologic licence application (BLA) or novel regulatory path,” he said.
However, despite the confusion, Schafer says some sponsors and CROs are starting to take notice.
“The pure economic potential from both the revenue side for biopharmaceutical companies, and the cost savings side for patients and healthcare providers, is staggering.”
He said the industry will soon see a trend the likes of the generics boom, with “the first wave of highly successful biologic products within shouting range of coming off patent.”
Schafer told us that for biopharmas, the chances to broaden their pipeline are huge, adding that more biosimilar companies will come out of the woodwork as generics firms have.
“ISR hypothesizes that if we updated this research in two years that the percentage of biosimilar-aware respondents would increase quite a bit,” he said.