On June 24th, ASBM Executive Director Michael Reilly presented at the 15th Biosimilars Congregation. The event was organized to provide insight into the current state of play in the EU with respect to biosimilars and stimulate debate, in a multi-stakeholder setting, on the vital role of biosimilar medicines in the sustainability of healthcare systems. It also highlighted key recent developments in regulatory science and regulatory policy in the EU and other international jurisdictions.
View Mr. Reilly’s presentation here:
Mr. Reilly’s presentation was entitled “Biosimilars: Patient and Physician Perspectives” and drew heavily from ASBM’s surveys of physicians in Australia, Canada, Europe, Latin America, and the U.S.; as well as discussing recent biosimilar policy trends globally.
The presentation focused on three key policy areas: 1) Interchangeability and Substitution; 2) Non-Medical Switching, and 3) Distinguishable Naming.
Reilly emphasized the cautious nature of physicians, who while strongly supportive of biosimilars, are reluctant to change medicines for patients who are doing well on their current therapy. This is evident from European survey data showing high comfort levels prescribing biosimilars to new patients (84%), but also high discomfort with a third-party-initiated switch to a biosimilar for non-medical reasons such as cost (73%).
While automatic substitution is rarely practiced in Europe, such policies have been enacted in Australia over physician and patient objections. In addition, several Canadian provinces have begun forced-switching policies.
British Columbia and Alberta have already implemented forced switching policies, and in April, New Brunswick announced it would follow them. In May, Quebec announced its intention to become the fourth province to require patients to switch to biosimilars.
Quebec’s National Institute of Excellence in Health and Social Services (INESS) had previously released a report called “Safety of switching biologics and their interchangeability”. It found strong opposition to forced switching:
All the learned [physician] societies are clearly opposed to non-medical switching of a biologic drug, and instead favour medical switching, by which the decision to switch a patient’s treatment rests with the individual and his or her doctor…this position is shared by all the clinicians consulted for this project, who stress that the physician is the best person to assess the risk of treatment switching in a given patient.
Finally, Mr. Reilly discussed the issue of biologic nomenclature. Lack of an international standard was identified by the World Health Organization as a key policy challenge in a 2020 report. In 2014, the WHO’s International Nonproprietary Names (INN) Programme’s Expert Group proposed a distinct naming system built around a Biologic Qualifier (BQ), a four-letter suffixed affixed to an INN shared by an innovator biologic and all biosimilars to that product.
Despite early broad support from many countries including the U.S., Australia, Canada, and Japan; the voluntary standard was never made available to national regulatory authorities.
Currently several countries, including the U.S. and Japan, use distinct suffix systems, while Europe relies on INN and brand name for product identification. Early supporters of the BQ including Australia and Canada have also followed the latter approach, but expressed willingness to harmonize with the WHO standard if it is made available.
