The available data on biosimilars in Europe are still insufficient to carry out a rigorous analysis to show correlations. However, given that the current moment is very important for companies that have to design and execute strategies in this segment, you must “work with what is there” and try to draw valid conclusions. Following with our survey on biosimilars in EU markets, this time we have reviewed data on two anti-TNF alfa whose first biosimilars were approved in Europe at about the same time: etanercept (January 2016) and infliximab (May 2016). The first finding that draws attentions was the difference in these biosimilars’ adoption curve in the first year: 30% infliximab versus 4% for etanercept. However, after that the curve is surprisingly similar, reflecting an annual adoption increase of about 20 points. As shown in the table below, there are major differences between Top EU markets.
The UK is in all cases the country with higher biosimilars penetration, due to successful promotion policies implemented by NICE. Germany is the only country in which both molecules achieve a similar penetration. It would be necessary a further analysis to assess whether it is related to the role of parallel trade companies as "equalizers".
There are quite large and remarkable differences in MS between molecules -ranging from 27 to 41 points- in Italy, France and Spain, always in favor of the earlier-launched infliximab. In order to account for the differences found between these two anti-TNF biosimilar products, launched almost simultaneously, an analysis was performed of two factors that we consider of utmost importance: the number of competitors available and the competitive strategies of the biosimilar manufacturers. Let's go a little more in depth.
Number of competitors
In 2016, two infliximab biosimilars were launched: Inflectra (Pfizer) and Remsima, (Mundipharma, Servier, Kern Pharma). In 2017, Flixabi (Biogen) followed and Zessly (Sandoz) at the end of 2018. On the other molecule, etanercept, Benepali (Biogen) was launched in 2016 and later in 2017 Erelzi (Sandoz).It is clear that there have always been more biosimilars of infliximab than etanercept and therefore more competition in market.
If we compare the adoption curves of these two anti-TNF biosimilars, they both follow the same pattern albeit with some relevant differences: the single etanercept's biosimilar launched in 2016, Benepali, gets just 4% MS the first year and then climbs to 40% at end of two years later, in 2018.
In the case of infliximab, by contrast, each of the two biosimilars launched in 2016 achieved a similar MS in 2016 and 2017 (roughly 15% the first year, followed by an additional 10% the second). Looking at the data, it seems clear that the adoption curve has been faster and steeper for infliximab than for etanercept.
It is also interesting to note that the adoption curve of the two infliximab biosimilars launched on 2016 follow the same trend the first year until Inflexa (Pfizer) clearly takes the lead in the second and gets on the way to overtake originator Remicade® –which it finally did in this 2019.
Competitive profiles and strategies
The other element that could have the greatest relevance in the differences found is the competitive strategies of the companies that have launched the products. They can be classified in two groups:
1. Large pharmaceutical companies marketing their own biosimilars
Pfizer and Novartis are two examples. Both companies have made a clear commitment to the generic and biosimilars segments. In the case of Pfizer, Hospira’s accquisition and the most recent agreement to purchase Mylan reflect its interest in leading also this segment of the pharmaceutical business. Regarding the molecules discussed here, Pfizer owns Embrel® (innovator of etanercept) and also Inflexa (biosimilar of infliximab). Embrel® still commands over half of the market, while Inflexa is close to becoming a sales leader among the top 5 EU markets for infliximab. We can therefore consider that its commercial strategy has yielded good results.
In the case of Novartis, the activity in generics and biosimilars has been mainly driven through Sandoz and Hexal for quite some time. Regarding Sandoz, there is limited data at the moment for these anti-TNF molecules, since both biosimilars were among the last to be approved. In the case of Erelzi, market share in the second year was 8% in Germany, the first country where it was launched and the only one that can be realistically included in this analysis.
2. Biosimilar manuifacturers launching through third parties
Two Korean companies, Samsung Biologics and Celltrion have developed biosimilars for these two anti-TNF molecules. Samsung got the approval of Benepali (etanercept) by EMA in 2016 and Flixabi (infliximab) in 2017, while Celltrion managed to get Remsima (infliximab) approved also in 2016.
Samsung Biologics achieved a global agreement with Biogen for the launch of its biosimilar portfolio in Europe. The two companies created a JV (Samsung Bioepis) and Biogen took 49.9% of the shares.
A newcomer into the world of biosimilars, Biogen is a Danish biotechnology company specializing in CNS drugs. Even today, CNS products account for over 80% of total sales and it is not clear whether biosimilars are a strategic bet or an opportunistic decision.
So far, results are dissimilar: in etanercept, Benepali managed to reach 40% of the market, although it should be noted that it was the first to launch with a wide margin on Erelzi. Flixabi, on the other hand, has barely managed to penetrate 5%, a very modest figure if we consider that infliximab biosimilars already control 63% of sales.
Celltrion, on the other hand, chose to distribute the Market Authorization (MA) for Remsima to different partners, namely Mundipharma, Kern Pharma and Servier.
Mundipharma, an intermediate-sized company with great success in the sale of pain treatment products and facing patent expiration of its products, was the partner of choice in the fastest adoption markets (UK, Germany) and also in Italy. In addition to Remsima, Mundipharma also acquired the rights to Truxima, rituximab's first biosimilar.
Results with Remsima were very positive in 2016 and 2017, reaching a 35% share, but in 2018 results worsened, being surpassed by Inflexa and losing 5% MS.
In Spain, Remsima is marketed by Kern Pharma, a local generics company with experience in the hospital segment. Market share grew from 10% in 2016 to 25% in 2018, however ten points below Inflectra's.
In France, Remsima was licensed to local leader Servier. Unlike Kern Pharma, Servier has experience in innovative products and also in some branded generics or generic +. In this case, in the first year only achieved 5% of MS was achieved but rising to 25% in 2018. As in the case of Spain, MS was 10 points below Pfizer’s Inflectra.
Conclusions
Still with the limited available data, the following insights can be gleaned, which do not contradict common sense.
In the cases reviewed, two biosimilars launched at the same time managed to achieve a deeper and faster adoption curve than just one.
Combining this case with insights from previous biosimilar studies, data shows that innovator has lost at least half of the market after three years from the launch of the first biosimilar.
The “early biosimilars adopters” are the UK and Germany. Italy, France and particularly Spain follow at a much slower pace. This trend is quite consistent across the various biosimilar molecules analyzed to date.
It is not possible to conclude that the companies that market globally biosimilars developed by them achieve better results than those that do so through third parties, since this would require an evaluation that exceeds the content of this article. However, in the case of infliximab, the strategy followed by Pfizer obtained better results in terms of sales than the one developed by Samsung in all markets.
It is difficult to assess whether the results obtained by non-European biosimilar manufacturers can be considered as good. Getting 40% (Benepali), 25% (Remsima) or 5% (Flixabi) after less than three years may be sufficient ... or not, depending of the expectations and competitor performance. Other considerations, mostly real profit, should help to determine the winners and losers on this game.
While three years or less is from all points of view not enough time to calibrate such a complex sector, as we mentioned at the beginning of this post, you have to work with whatever data is available because it is not possible to wait for more data to make strategic decisions.
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