Educating Doctors and Patients on Biosimilars

This article was written in collaboration with Liese Barbier, Teresa Barcina Lacosta, and Yannick Vandenplas.

Since the introduction of biosimilar medicines in the European market in 2006, biosimilars have made their mark in multiple therapeutic areas, including oncology, inflammation, hematology, and endocrinology (1).  As of March 2021, the EMA has authorized over 65 biosimilar products and in the next 10 years, a considerable number of originator biologicals is expected to lose market exclusivity and be exposed to biosimilar competition (2,3). 

Biosimilars have been safely and effectively used, exceeding a total clinical experience of 2 billion patient treatment days across Europe (4). Currently, biosimilars represent a 60% year-on-year growth in the share of the total biologics market in Europe, and this figure is expected to increase, based on the considerable number of biologics expected to lose market exclusivity in the next 10 years (3). Altogether, these data underline that biosimilars are here to stay. In this context, it is essential to ensure that the different stakeholder groups receive trustworthy and clear information about the principles and the value proposition of biosimilars.

Successful implementation of biosimilars

This article first appeared in the Info-BioSim e-newsletter produced by Panacee Conseil Inc., April 2018.

With almost 40 biosimilars licensed over the past 12 years by the European Medicines Agency, it is safe to say the licensing pathway is well established. Hundreds of thousands of European patients are using biosimilars, and there has not been a single serious incident with any of them. Moreover, pharmacovigilance programs have shown that the risks involved in using biosimilars are no different than with the innovator products.

However, if we look at biosimilars in Europe, we see a large variation in the uptake of these low-cost alternatives to high-cost innovative biologics. The northwestern part of Europe (Scandinavia, United Kingdom, Germany, the Netherlands) have seen big cost reductions due to the use of biosimilars, while in the southern part of Europe the uptake is much lower, which raises the question: Why is that so?

Cost effectiveness of medicines

This article first appeared in the Canadian Pharmacy Newsletter, March 2019.

Biosimilars and the European Regulatory System

In the 1990s, governments and regulators in Europe began thinking about how to regulate biological medicines once patents expired and market exclusivity ended. Given the extensive experience regulators already had at that time assessing the manufacturing changes of biologics, they concluded that a simple generic pathway would not be advisable. As a result, Directive 2001/83/EC (translated in the laws of all EU member states) was amended with the addition of Article 10(4), which introduced the concept of “similarity.”

Research and development of medical drugs

This article first appeared as a contribution to the 'Key Opinion Leader' series produced by Panacee Conseil.

All physicians and pharmacists involved in the prescribing and dispensing of medicines know that adopting a positive attitude when providing patients with a medicine can markedly enhance its therapeutic effect. If a patient has positive expectations, it is more likely the drug will have a beneficial effect than if the patient is skeptical about the drug. In this way healthcare professionals can significantly enhance the effect of a drug, which is why the double blind placebo-controlled trial was invented, to eliminate this influence in drug efficacy studies. So, what do we see in such trials? The placebo has beneficial effects, but can also generate a variety of side effects about which the patient was told in the informed consent procedure.

Since the 1970s, we know that the reverse can also be true: If a patient has the impression that a medicine may be less effective or is inferior in quality (sometimes perceived as such, due to a lower price) then its pharmacological efficacy may be compromised and there is a chance the patient will experience decreased benefits and possibly also increased side effects. This phenomenon was first studied extensively when generic medicines with exactly the same composition, even those from the same manufacturer, induced unwanted effects in patients. Could it possibly be something like a reverse-placebo effect? The answer is yes. Patients who are told that their medicine may not be exactly the same (similar but not identical) or that it could cause side effects (not necessarily different from the original) may have a different therapeutic outcome.

The difference between generic drugs and biosimilars

This article first appeared as a contribution to the 'Key Opinion Leader' series produced by Panacee Conseil.

My journey with biosimilars started when I became director of science & education at the European Association of Hospital Pharmacists in 2002, and soon thereafter assumed responsibility for the association's journal, European Journal of Hospital Pharmacy (EJHP). It was at that time that patents of key biological medicines like growth hormone, epoetin, and filgrastim were due to expire and became available for copying.

Around the same time, Johnson & Johnson reformulated its epoetin product Eprex, which some time later was linked to an increased occurrence of PRCA (pure red cell aplasia), a rare formation of antibodies to erythropoietin. The medical community was alarmed that a change in the formulation of a biological medicine might actually result in a detrimental side effect in patients. What could be the consequences if reverse-engineered copies were to be used in patients?