Conclusions of a survey on biosimilar adoption in the EU Top 5 A few weeks ago I published an article in Biosimilar Development on the adoption of biosimilars in major EU countries since the approval of the first, Omnitrope, in 2006 (https://www.biosimilardevelopment.com/doc/eu-biosimilar-adoption-what-can-the-past-tell-us-about-the-future-0001).
In that article, we analyzed the four families of biosimilars (hormones, factors colony stimulants (G-CSF), MAbs, heparins) and showed the great heterogeneity of the data depending on the molecule, the country and the time of launch. Although few conclusions could be generalizable for the future, the underlying fact is the need that Western governments have to keep budget under control in the perfect storm ahead: increased use of biologicals, personalized therapies, an aging population with greater life expectancy and a possible budding economic crisis. To this end, biosimilars are a more than necessary, essential tool, so we can only expect new promotional measures, as well as a relaxation of the current restrictions for the exchange of products and high pressure on the prescriber.
The second question of interest is whether the launch of biosimilars stimulates the use of the molecule. The criterion that would support a positive response is simple: the high price of the biologic slows its use in “diffuse” cases, for example, in those in which the strict application of the pharmaco-economy would not endorse the use of the original but perhaps if of the biosimilar. We have evaluated the research conducted by Emergpharma that includes data for the 2016-2018 period. Sales were analyzed in units per molecule and compare the results with the adoption of biosimilars in the 5 markets: UK, Germany, Italy, France, and Spain. In total, nine molecules corresponding to the four groups mentioned at the beginning of the article have been evaluated. Next, we expose the main conclusions and take-aways.
The first thing to note is that we cannot establish a clear trend that serves all cases. There are significant differences between groups, within groups and in different countries. There is an additional difficulty in dealing with molecules that have received the approval of biosimilars over a long period (more than 12 years) in which the image of these products and their needs have varied considerably. Let's see the results by molecule.
Omnitrade, a biosimilar to Somatropin was first launched in Europe in 2006. There are five original molecules from the same active principle and only two biosimilars. Penetration has been very low despite the time elapsed, and the molecule moves in very discrete growths. On a consolidated level, the units sold in 2016 and 2018 are practically the same, and if we perform the analysis by country, we see that the changes range between -5% to 3%. In this case, it is not possible to establish any relationship between the adoption of biosimilars and the greater use of the molecule. Although such a relationship existed, it would be very difficult to prove it since its incidence would correspond to the participation of biosimilars, less than 15%.
The first biosimilar of Lantus appeared in 2014 in Europe. In the first four years, only in Italy have reached a share of more than 15%. In the period considered in the study (2016-2018), the molecule decreases in the UK and reflects small growth in the other markets studied, except in Germany where it has grown by 13%. In light of the data and as in the previous case, we cannot affirm that there is any correlation between the adoption of biosimilars and greater use of the molecule.
In the UK, where surprisingly the biosimilar penetration of this molecule has been very low (8%), the growth has been slightly higher than 10%. In France, where penetration has reached 35%, the molecule has grown by 25%, while, in Germany, Italy, and Spain, with market shares surpass 70% in all cases, the growth is between 25 and 40%. We cannot affirm with these data that the greater adoption of biosimilars is the cause of this growth, although it makes some sense and the data is consistent in the four markets (discarded UK).
The case of this molecule is a bit more complex. In the UK and France, the growth experienced in the period considered is 25%, while in the rest of the territories they move between a 7% decrease to a shy increase of 3%. No conclusion can be drawn in this case, since in all countries the market share of biosimilars has very similar levels (around 50%).
One of the molecules that have been on the market for more than 10 years, is also the one that reflects a greater penetration of biosimilars, with market shares ranging between 82% in Germany and 99% in the UK. In this case, it is difficult to determine if the increase that the molecule has experienced in the period considered (between 4% and 34% depending on the country) has to do with the fact that the biosimilars are practically the entire market, with price reductions sometimes higher than 90% over the original, although it makes sense to think so.
Since the launch of the first biosimilars was in 2017, the available data is scarce to establish any correlation, although the truth is that the molecule has sold fewer units in all the markets studied (between 7 and 1% less) except in France where it records a slight increase (2%), but hardly attributable to l biosimilar, as it is and represents only 2% of the market.
The appearance of the first biosimilars of MAbs have been a turning point in this category of products, first, by the rapid penetration, unknown until then, managing to reach half of the market in just two years, and also by the increase in the use of the molecule, far superior to what happened in the other categories. Between 2016 and 2018, Infliximab won between 11 and 23% of units and grew in all the markets studied.
In this case, the registered growth has been more unequal, close to 20% in the UK and Germany, countries where biosimilars already account for more than half of the market, 5% in Italy, where one-third of the market is biosimilar and negative ( -3% and -1%) in France and Spain, where penetration is below 30%.
Rituximab has been the first essentially oncological MAb to be launched. Their level of penetration has been even higher than the previous two. It is very possible that it's eminently hospital administration and the security that this environment offers has had to do with this rapid adoption. It also seems clear, in the light of the data, that there has been no overall increase in the use of the molecule as a result of this rapid adoption. In fact, it only grows in France, remains almost flat in Italy and decreases in the other three (UK, Germany, and Spain).
The first conclusion that can be made of the data presented above is that, at least in Europe, it cannot be said that the entry of biosimilars increases the use of the molecule. At least, not in all cases. For filgrastim or epoetin alfa, it is likely that the reduced price of biosimilars is facilitating increased use as therapy s adjuvant s in Oncology to and immunologic other diseases, but in the case of the other hormones or heparins, it does not seem to happen.
In anti-TNF for the treatment of inflammatory diseases, the growth of the molecule and the increase of biosimilar use go in the same direction and, although it is not possible to affirm that both things are related, if it is true that the growth, in the case of infliximab, has accelerated since the launch of these.
Finally, in the case of the only purely oncological anti-TNF analyzed, we cannot say with these data that the appearance of biosimilars corresponds to greater use. In a way, this was expected, since in the countries included in this study the health coverage is universal and a patient will not be denied treatment, either with a biological or a biosimilar, provided that it is available and approved. As discussed in other published articles, the adoption of biosimilars in these markets is a need that affects health authorities more than directly patients who, at least individually, do not get any benefit from the change since they do not pay the pharmaceutical bill directly but through their taxes and contributions. If this survey had been carried out in another context, for example in emerging countries, it is probable that the results would have been very different.