Michael Reilly: Forcing patients to switch to biosimilars puts them in uncharted waters

On May 27, the B.C. government announced a policy that will forcibly switch thousands of patients, effective Nov. 22, with serious, chronic conditions from their current biologic medicines to lower-cost “biosimilar” treatments.

The roughly 23,000 patients who will be affected include those with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, diabetes, Crohn’s Disease and ulcerative colitis.

Such switches are widely accepted with generic versions of small-molecule drugs, which are identical copies of the originator medicine. But biosimilars, while highly similar to their reference products, are not identical.

In making this decision, Health Minister Adrian Dix correctly observed the comparatively higher uptake of, and savings from, biosimilars in Europe. Europe and the European Medicines Agency have been the leaders in the development of a regulatory framework for biosimilars since the early 2000s, with the first biosimilar approved in 2006 and a total of 60 approved biosimilar products/brands covering 17 originator molecules to date.

But biosimilar market shares across Europe vary widely between 41 per cent and 91 per cent for those approved before 2012, and between five per cent and 43 per cent for those approved between 2013 and 2018. As with innovative biologic medicines, their uptake has evolved over time as both physicians and patients gradually gained experience with this new class of medicines.

Biosimilars have increased competition, expanded the choice of products physicians can choose from, increased the number of patients with access to these highly effective biologics, and provided headroom to fund innovative drugs.

However, it is important to note that in the vast majority of European countries, the decision of what medicine to choose has remained with the treating physician in consultation with their patient — contrary to the government mandated forced switch of well-treated patients announced by Dix.

Like the European Medicines Agency, Health Canada states that, one, biosimilars are not considered generics, two, that the authorization of a biosimilar is not a declaration of equivalence to the original biologic drug and, three, that the authority to declare two products interchangeable rests with each province and territory.

Furthermore, Health Canada, European Medicines Agency, recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction.

With the above in mind, it is important to differentiate between two types of patients:

First are those about to begin treatment on a biologic, for which a biosimilar is available — referred to as “bio-naïve” patients.

Second are patients who have been fortunate to see their disease controlled or even reversed, possibly for years, with an original biologic. This latter group has often tried multiple different products before finding the one that has stabilized their condition.

For the new patient, a choice between the original biologic and a biosimilar would be the choice between two equals, given the patient’s non-exposure to either medicine in the past.

Yet for the second group — the patients who are stable on their current medicine — switching a well-treated patient from their familiar and effective original biologic to a biosimilar is a thoroughly different decision. It’s even more so if such a decision is mandated for all patients and not left at the discretion of the treating physician who alone is able to make such a judgment call, weighing all the pros (cost) and cons — change of syringe/pen, patient compliance, adverse events, immunogenic reactions, possible change to a different drug altogether, etc. — plus the time and resources required by physicians and their staff to provide the necessary information to each patient.

Despite the first biosimilar approval in Europe in 2006, the number of approved biosimilars, even in Europe, is still relatively small. The vast majority of EU countries have treaded carefully as their policies have evolved, seeking procurement solutions that would promote competition, maintain product choice and preserve physician autonomy.

Over time, prices have come down and, as physicians have gained experience, more patients have been treated, even though at varying degrees depending on the type of biologic/biosimilar. That reflects both the level of competition but even more so the differences in disease complexities, patient types and resulting considerations for successful treatment outcomes.

The vast majority of European countries do not serve as a reference for a forced-switch biosimilar policy like the one introduced in B.C. Biosimilar uptake in Europe has mostly been a result of building physician trust and confidence, rather than force. Instead, the European success with biosimilars stems from extensive stakeholder education, frequent communication, refined procurement policies and a recognition that only a long-term, sustainable biosimilar market will secure the continued development of new biosimilars and their adoption by both physicians and their patients.

Michael Reilly is executive director of the Alliance for Safe Biologic Medicines, an organization composed of healthcare groups and individuals, including patients, physicians and biotechnology companies, that develop innovative and biosimilar medicines and others working to ensure patient safety is at the forefront of biosimilars policy discussions.