Medicines for Europe Experts Discuss Biosimilar Offerings, Substitution Part II


In this second part of a 2-part series, Tony Hagen, editor-in-chief for The Center for Biosimilars®, interviews Adrian van den Hoven, Managing Director of Medicines for Europe, and Diogo Piedade, Head of Market Access for Medicines for Europe, about the findings of the group’s recent European survey on biosimilar markets : Market Review — Biosimilar Medicine Markets.

Van den Hoven and Piedade continue the discussion on EU market tenders, or contracts that grant exclusive or near-exclusive rights to supply an organic product to a geographic area or to a healthcare facility.

They note that for Denmark, the awarding of multiple tenders for an organic type allowed the coherence of the offer and ensured a healthy level of competition.

They also discuss the prevailing trends regarding the initiation of biosimilar treatment-naïve patients and policies for change. Most countries have gained confidence in biosimilars by prescribing them to start treatment-naïve patients, and now the standard is closer to a change in policy, as studies and experience confirm the equivalence of these products. with the princeps, says Piedade.

The United States is proposing an interchangeable designation that allows pharmacists to substitute biosimilars over the counter without physician intervention, and in the European Union it would appear that without such a designation pharmacists are free to make substitutions of biosimilars. biosimilars also without having to check with doctors first, but in practice it doesn’t work that way, van den Hoven and Piedade explain.

“There are cases where the pharmacist may need to change the medicine, but in these cases he will consult the doctor,” explains van den Hoven.

Biosimilars in the European Union have switched to treating early stages of the disease in some countries, and this has been a boon for patients who previously had to use less optimal drugs first, explain van den Hoven and Piedade. This development has depended in part on a growing awareness and understanding of biosimilars through support efforts which differ considerably from one Member State to another.

The lessons the European Union has learned from the release of biosimilars could also be instructive for the United States. “What I’m seeing in the United States now is that health insurers understand that just because a biosimilar is cheaper doesn’t mean it’s going to be prescribed. You actually need what I would call an active policy to support the use and competition of biosimilars, ”says van den Hoven.

Health systems across EU member states vary widely, but the introduction of benefit-sharing, unbiased educational resources and clear direction is common among those who have been successful with the adoption of biosimilars, says Piedade.

“These countries have a very clear and very well defined national goal and roadmap so that they are clear about where they want biosimilar uptake and how to get there,” he says.

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