>> Prof. Dr. opened with clear theses. Jürgen Wasem, chair of the Alfried Krupp von Bohlen und Halbach Endowed Chair for Medical Management at the University of Duisburg-Essen, the HSK satellite symposium “Opportunities and risks for biosimilars in Germany”. According to Wasem, it also applies to biologics that although society is prepared to pay for research and development during the phase of patent protection for the original, once the patent has expired it is “the legitimate wish of society to no longer make contributions to research and development of the original to remunerate”. Biosimilars are “a necessary means” for this purpose, although – unlike generics – biosimilars also incur larger development costs that would have to be reimbursed. But, Wasem warns: “Strategies by original manufacturers to delay the use of biosimilars through patent law must be viewed critically from a societal perspective.” According to Wasem, cost reduction and improved access to care are “central regulatory goals in the tension between market access and price competition.” The instruments in the German pharmaceutical market, he demands, “must adequately balance this tension.”
But the reality looks somewhat different. Reference price instruments of the fixed amount type and exclusive discount contracts are competing approaches, as illustrated by
bright Prof. Dr. Uwe May, dean of studies for the master’s program “International Pharmacoeconomics and Health Economics” at the university
Fresenius in Idstein, in his lecture. Both types of instruments and their effects are subject to uncertainties, implementation difficulties and risks of various kinds, which are, however, partly due to the specific circumstances in the biosimilar market.
All sorts of research questions arise here, some of which the lecture was dedicated to, for example what the situation is with biosimilars (Bios) and their relationship to the original, and what specific features there are in the Bios market (Fig. 1). But also, and this is perhaps the most important thing: which regulatory goals should be pursued and once these have been defined, what consequences this has for the regulatory process. Only then, May continued, can we talk about implications for the selection of suitable regulatory instruments. However, instruments that are currently being used in some cases without knowing what possible consequences they will have.
Anyone who thinks about regulatory goals cannot ignore the conflicting goals that are inherent in this market. These take place in an interdependent structure, formed on the one hand by the antipodes of market access and price competition, flanked and complicated by the desire for better access to supply on the one hand, but the need to reduce costs on the other, with all of this being the function the step innovation remains undefined (Fig. 2).
In addition, according to May, there is a conflict of objectives: that of short-term versus long-term cost reduction. With consequences, because higher price differences lead to higher savings per biosimilar, but higher price differences may also lead to fewer market entries.
There are certainly not too many at the moment. When comparing regional markets, you quickly see that the current bio-similar market is more than manageable. The number of approved biosimilars in the USA is just 8, in Japan 7 and in Europe at least 35. According to May, this means that Europe is currently both, due to the approval requirements of Japanese and American authorities and the social policy framework in these countries The key biosimilar market in terms of both sales and revenue.
Whether 35 is a lot or a little can be seen by looking at the indication fields covered, for example if you look at biosimilars in the EMA approval process: for adalimumab (immunosuppressant) and bevacizumab (antineoplastic drug) there are 2 each, for infliximab (also an immunosuppressant) and insulin glargine (insulin), however, only one each, with trastuzumab (another antineoplastic drug) 3 and with pegfilgrastim (immune stimulant) even 4.
But the suppliers in the biosimilar market - which include Eli Lilly with one product, Amgen and Biogen (2 products each), Pfizer with 3 and Celltrion (the only company not from the USA, but from Korea) with 6 products - are still there expandable. May says: “All providers are represented on the market with only a few biosimilars, so that in the active ingredient markets a small number of companies compete as providers in a narrower or wider oligopoly.”
Now one might ask, why do these companies, most of which come from the USA or Korea, care about the regulatory situation in Germany? A lot, as May found out in a survey of 23 managers from 18 companies (70% of those surveyed work in companies that operate worldwide, 22% predominantly work in Europe and almost 9% predominantly work in Germany). According to May, the German regulatory situation naturally influences the market launch in this country 100 percent. According to the biosimilar managers surveyed, 64 percent also wanted to market the market
Europe, as well as 79 percent even the fundamental question of development as such.
“The company survey underlines the high importance of the German market and the high influence of regulatory instruments on market entry decisions,” explains May, explaining the survey results. He further concludes that when balancing an incentive-compatible regulatory system, it must be taken into account that the refinancing of manufacturers' R&D investments as well as market launch costs of approval and license holders in the biosimilar market is currently "not at a global level, but mainly within Europe and, last but not least, to be earned in Germany. This even leads him to talk about “Germany’s international responsibility as the largest European pharmaceutical market”. In his opinion, “negative external effects on the pharmaceutical markets of other countries,” which could result from German pharmaceutical policy, should also be avoided.
But what does it look like in Germany? According to an evaluation by AG Pro Biosimilars (see page 30) based on the NVI figures from INSIGHT Health, in 2017 “the share of biosimilars in the supply remained far behind the possibilities”. The share of sales of biosimilars in the biosimilar-capable market would have been only 5.4 percent in 2017 as a whole.
Prof. Dr. Diana Lüftner, senior physician for hematology and oncology at the Charité University Medicine in Berlin, also knows exactly why this is the case. That's why treating doctors from all three Charité locations sat down, discussed this topic and each presented their sensitivities. In the end, it was decided and “benevolently” agreed by everyone that the original preparation and biosimilar were the same, and that costs could also be saved. According to Lüftner, 90 percent of new patients at the Charité are now being treated with biosimilar antibodies. But not the “old patients”, because the Charité has set an internal rule not to switch untargeted, which is why the preset ones remain on the original preparation. But they will expire at some point.
Lüftner also has an answer to the question of why not 100, but only 90 percent of the eligible patients are treated with biosimilars and uses the example of trastuzumab to illustrate this. “Some colleagues,” says the experienced oncologist, “are bothered by the fact that there are no combination data with pertuzumab.”
This is a psychological phenomenon that divides the world of practitioners into two parts: the side of the pragmatists (“no data, but the same thing”) and that of the “intellectual mental cinema oncologists” who say: “For God's sake, what What do I do when a patient comes in who has a non-response to pertuzumab and trastumab, gets a biosimilar, but she hasn’t been informed about it?”
Which is not that easy, because unlike in America, where biosimilars can be clearly identified by an addition to the generic name, this is not the case in Europe. According to a study by the biotech association “EuropaBio”, this lack of transparency is also currently limiting the acceptance of the alternatives, which are on average 30 percent cheaper, among prescribing doctors. <<