Vince & Associates, an early phase contract research organisations (CRO), recently announced it had successfully completed enrolment of a biosimilar trial with almost 150 subjects, and though confidentiality restricted them naming which reference product the biosimilar was based on or the name of the sponsor, the firm spoke to Biopharma-Reporter.com regarding the challenges involved.
“Because of their complexity and unique manufacturing methods, there is an inherent variability and thus the development of an exact biologic is simply not possible,” CEO Dr. Brad Vince told us.
Furthermore, such trials “require a higher level of physician oversight,” he continued,
“and because of the potential for infusion reactions volunteers often need premedication.”
Parexel supported such a view, with biosimilars experts Cecil Nick and Bruce Babbitt telling us “physicians generally lack an adequate understanding of biosimilars” and thus “a great need exists to effectively communicate the concept of biosimilars and their value to patient care.”
Parexel also said the low level of novelty of a biosimilar study compared to its reference product causes challenges in recruiting patients.
This was an opinion supported by Dr. Dirk Reitsma of rival CRO PPD. He told this publication: “For some of the earlier biosimilars, the pool of patients seems to have become constrained as the number of competing biosimilars in clinical development has increased.”
However, Vince countered such a view telling us “recruitment is actually easier for these types of trials as the side effect profile is already well established for these marketed biologics.”
Regulations and Demand
As Europe steps up its biosimilar approval – the first biosimilar monoclonal antibodies, Inflectra and Remsima, were approved in September – and the US has an increased focus, Vince said his company has seen “significant demand in the past six months for these types of trials.”
This led us to ask the CROs how decisions made by both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) affected trials for biosimilars.
“Regulators (initially in the EU but now more often in the US) are meeting complex issues associated with biosimilars head on,” said Parexel and, in its experience meeting with both regulatory bodies, are sticking “closely to requirements and recommendations for biosimilar development provided in their published directives, laws and guidances.”
Investigator interest is generally higher for conducting trials with novel agents, PPD’s Reitsma added, though his firm has also seen “interest from sites increase along with awareness of developments around biosimilars.”
He continued: “As additional biosimilars receive marketing approvals the level of interest in the investigator community in conducting biosimilar trials will increase.
“Beyond that, we find that the same general principles that work for trials with novel agents, such as engaging investigators who are familiar with conducting clinical trials and who are successful in meeting their enrolment projections, also work for biosimilar trials.”