EBG Biosimilars 2015
EGA: Low patient recruitment sends biosimilar trials to Eastern Europe
Sponsor companies are moving trials to Eastern Europe to try to find study participants, investment analyst Ronny Gal of Sanford Bernstein, told an audience at the 13th EGA-European Biosimilars Group Conference on Thursday.
“Some of the players who are trying to get into the market first are pushing for trials in Belarus, Ukraine, Hungary, Poland.
“The idea is to have a few centres, where you have very tight control over what a centre does, minimise variability, and recruit a lot of patients for those trials.”
But Gal said a strategy of concentrating trials is one region could bring its own problems.
“I wonder if at any point will the others begin to argue that a trial with primarily Eastern European population will be non-representative.”
Other companies are beginning to cast their net wider with a “brute recruiting approach”, spreading a few centres across several different countries, bringing greater genetic variability, he said.
However biosimilar makers decide to solve the recruitment process, Gal was clear it is currently a problem of “extreme difficulty” and a “fly in the ointment” for gene therapy.
Persuading physicians in the UK, France and Scandinavia to participate is a particular hurdle.
“Doctors do not see the benefit of their patients being on those trials, although there are clearly system benefits. And most of those trials go elsewhere.”
This view was seconded at the conference by Joerg Windisch, Chair of the European Biosimilars Group (EBG, part of EGA) and Sandoz Chief Science Officer.
Windisch said the answer lies in assuring doctors – who prize clinical data over other kinds – of the safety and efficacy of biosimilars compared to originator biologics.
“If you look at the evidence that leads to approval of a biosimilar, you’re connecting the biosimilar to the clinical data and experience of the original product.
“The most sensitive way of doing that is with all the state of the art functional and analytic data you have available. But that’s typically not what clinicians understand by the word ‘data’. So that’s where the education comes in.”
Windisch said approvals of the first generation of oncology biosimilars will help persuade doctors in other specialties “and then the dam will break and it will get easier. Pioneering work means clearing the brush.”
He stressed the difficulty of convincing doctors and patients to try a biosimilar in countries where the costs of originator biopharmaceuticals are reimbursed.
“There you have to work with physicians who understand the long-term effect biosimilars will have regarding long-term access and sustainability of healthcare systems.
“It may seem naïve, we actually thought so a few years ago, but you can actually find these people. If you collaborate with them, they have a network of other people; it’s contagious.”
Willingness to go into biosimilar trials is higher in countries where access to reference products is lower and more expensive, he said.