Interview: Medicines for Europe Reports on EU Biosimilar Success

Biosimilar competition doesn’t happen on its own. It requires incentives and a competitive market structure to keep biosimilar manufacturers interested in participating. The winner-take-all tender system in Europe, which allows a single biosimilar to gain preferred status, has the undesired effect of causing unsuccessful competitors to drop out of the bidding process in ensuing years.

These were some of the conclusions officials from the trade association Medicines for Europe reached in a country-by-country analysis of biosimilar success in Europe.

The group produced a 12-country scorecard that evaluated policies and progress as measured by biosimilar competition, price reductions, and overall increase in use of drugs for which biosimilars are available. The report was done in partnership with the IQVIA institute for Human Data Science.

The Center for Biosimilars^® (CfB) spoke with Adrian van den Hoven, director general of Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about their observations.

In Part 1 of this interview, van den Hoven and Piedade explain why a deep dive into the biosimilar market development in Europe was needed. They describe how this knowledge can improve patient access through introduction of policy change and a competitive framework for biosimilars introduction, and they describe the importance of a sustainable system.

Van den Hoven and Piedade also discuss national examples of biosimilar market success from Poland, which has struggled, and Norway, which has done well but does not have uniform access between hospitals and clinics. And they provide thoughts on the introduction of a multi-tender system that would keep biosimilar companies interested in staying in the marketplace even if they do not win preferred status.

For reference, the scorecard report produced by Medicines for Europe and IQVIA can be accessed here.

CfB: What led you to put this report together?

Van den Hoven: The European [biosimilar] market has been under development for [many] years now, and so there have been growth in some areas and difficulties in other areas. We really wanted to do an assessment of which policies were having a positive benefit in terms of patient access to biologics, and which ones were having less of a benefit. We also tried to look at it from the perspective of how sustainable the market would be over time.

We've done a few reports before, but we've never gone this deep into the specific measures to see how effective they are, what are the benefits of the different policy tools that can be put into place, and what is the interconnection between different policy measures applied together, to make it work in practice and adapt it to slightly different situations in each European country. We have a so-called single market in Europe, but we have different pricing and reimbursement systems, ultimately.

Piedade: Whenever you look into these policy aspects, it can get very technical and very heavy, very quickly, so we wanted to create a tool that acts as a conversation starter. So, at glance, you can quickly look at one of the scorecards for one of the 12 countries and know the areas where policy improvements can be made and the areas where, in terms of biosimilar policy, that country is faring better or not so good.

CfB: Who do you think is going to benefit most from this report?

Van den Hoven: We hope that first of all patients are going to benefit, because one of the challenges we still have in in Europe is that when you don't have a lot of competition from biosimilars, you still have a lot of restrictions to access because of the cost. There are essentially a lot of hidden restrictions in the European system. We hope that these policy tools can help different policymakers introduce a better system that will increase biosimilar utilization and remove some of the restrictions to access the biologics in general.

A lot of people think about Europe that because we have subsidized state health care, that somehow means you have no access issues. Unfortunately, it's not the case. We do have restrictions, notably for biologics, not just in Eastern Europe, which is less affluent, but also in Western Europe. But I think for us, that's the first target.

Piedade: We took a broad look at biosimilar sustainability with this report. We want to make sure that sustainability means that it's sustainable for all the stakeholders involved. That also encompasses the health care systems, the prescribers. We also hope to bring more prescriber options to the table and to the health care systems, with increased efficiency. We also hope that these points are taken in by policymakers, and they are the ones that should be enacting the changes that we are advocating for here.

CfB: So, what have you learned about the progress of biosimilars in Europe and in particular European countries?

Van den Hoven: I think one of the key lessons to learn here is that biosimilars competition doesn't happen on its own. You need measures to stimulate the competition, to encourage use by stakeholders—physicians, principally, because they are the prescriber, and they may choose to prescribe the biosimilar or the reference product. And so certainly without stimulus, there will be no competition. You can see that wherever you don't create a competitive playing field, there is almost no uptake. A good example of that is insulins, where there's very limited biosimilar uptake, because there are effectively very few measures to encourage competition in that space. In Western Europe, at least in the field of oncology, you see a massive uptake in the use of biosimilars, because there are a lot of measures to support competition.

Piedade: What was interesting to find as well was that the countries that have a more intentional policy framework, a willingness to adopt and to make the most out of the benefits of biosimilars, are the countries that are able to expand access. And then it's very clear, as well, that those countries where policies are not so well defined or they do not support the use of biosimilars, then you see them lagging compared with other countries in terms of access.

CfB: Can you give us some examples of markets that are ahead or behind?

Van den Hoven: I can point out one country where I'd like to see some action. That's definitely Poland. I previously mentioned oncology biosimilars. And in Poland, they have very heavy restrictions on expensive medicines. This is to obviously control the budget, but what it means is that you have an incredibly low access to biologic treatments like trastuzumab, and we've seen that although they have biosimilar uptake or biosimilar competition, they haven't removed the restrictions to access. So, basically the government has lower prices, but it doesn't have higher use. And this is really a sad situation, because the level of access is so low that it really means a lot of patients are not getting the correct treatment. So, something I'd really like to see is that in countries where biosimilars definitely have a price-lowering effect on the market, they give those benefits back to the patients in terms of expanded use to deal with those access issues.

Piedade: Poland is a good example. What is interesting as well is that even those countries where you would assume that the biosimilar framework is fully functioning or it's faring better, even those have points in need of improvement.

Norway is frequently regarded as one of the champions, but despite having good biosimilar uptake in the hospital setting, they still lag in the clinic setting. And then you have for other European countries quite a similar picture, where what is interesting and striking is that depending on the national context you'll see very different recommendations from one scorecard to the other, from one country to the other, because the policy framework and the different interplay between the national framework and the policies implemented will have different recommendations and points for improvement.

Van den Hoven: In some European countries, we have a form of national hospital tendering, where an entity buys on behalf of the hospitals, and those systems have been pretty effective to generate a high level of competition, even up to a 100% market share for the biosimilar, and pretty positive to stimulate biosimilar competition.

The downside with those systems is that if you are not the winner of the tender, you have a tendency to want to exit that market altogether and not participate in, let's say, the tender the next year. And over time, what that leads to is a reduction in the number of companies that want to want to participate in the different markets. We're starting to see now some experiments with countries or systems trying to introduce multi-winner tenders, so that the lowest bidder gets a bigger market share and a bigger benefit, but the next one down can also participate in the market. We're seeing this being toyed with or experimented with in Denmark, in the United Kingdom. We think those are good initiatives because we still believe that even after you have biosimilar competition, keeping competitors in the market and keeping a healthy competitive market is a good thing. That healthy competition will keep the market at bay over the long term. You may not get a dramatic, short-term win, but you'll get a definite medium-term gain by having sustained competition.