Biosimilars: Looking to Europe

At a recent AMCP industry workshop, experts highlighted the need to look to the European market experience with biosimilars to understand the potential impact from a US perspective.

Brenda Motheral, PhD, CEO, Archimedes discussed policy and economic considerations in the session, “Biosimilars: A Candid Look at Opportunities and Expectations.”

The four areas in Europe where biosimilars are present are: erythropoietin (EPO), human growth hormone (HGH), granulocyte colony-stimulating factor (G-CSF), anti-tumour necrosis factor (anti-TNF).

Despite the progressive introduction of these biosimilar versions, there remains a “high degree of variability within the drugs and within the countries themselves, in terms of what that biosimilar penetration has been,” Dr Motheral said.  And although it is frequently reported that the penetration rate in Europe is approximately 30%, that is not always the case.  “In fact if you try to identify any particular country and drug where that penetration actually is only 30%, you really only get 3 instances,” she said, referencing an IMS study assessing biosimilars in the European market [Assessing biosimilar uptake and competition in European markets. IMS Institute for Healthcare Informatics. October 2014].

For instance, HGH has a penetration range of basically 0% to a high of 100%; similarly, EPO has a low of 1% and a high of 65%.

While biosimilar penetration is one key variable to the overall cost savings, the second key variable is what is the actual cost savings for these biosimilars over the reference product.

According to the IMS study, “a measure of the evolution of price within the accessible market provides evidence of whether the reduction in overall costs from competitive price pressure has resulted from the introduction of biosimilars.” Of the European countries studied, the median price reduction from 2006 to 2013 was 35% (use of rebates was not reflected in the study).

Dr Motheral points out, however, that as with biosimilar penetration, there is a great degree of variability from country to country. “There’s quite a bit of variable even overall. Its hard to get a median, but it tends to skew more toward the positive,” she said.

From a financial perspective, the main concern is what happens to overall costs in these therapeutic classes when biosimilars are available. And while the European biosimilar experience has provided an abundance of data, the varying degrees of penetration and cost savings make the takeaway for the US difficult to grasp. “Its very hard to take that experience and really articulate and apply what pieces you are going to apply in the US and what you are not,” Dr Motheral said. 

This presentation was sponsored by AbbVie, Inc.