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Biosimilars following same pattern as generics? Neupogen keeps just 6% of EU market after 10 years.

Twelve years after the launch of the first biosimilar in Europe, there are still limited data available on the medium-term impact of the introduction of these products on the prescription habits of doctors and on the cost savings that can be expected. It is a topic of vital interest for the sustainability of the health system in the main EU countries since, if not able to generate the necessary savings, access to new medicines ready to be approved, many of them biological and expensive, will be more than challenging. A double digit or even over 20% growth scenario in some therapeutic areas such as Oncology or Inflammatory/autoimmune diseases is something that European budgets might not be able to face, particularly in a recession scenario foreseeable in the near future.

Policies promoting the use of generics have represented an important relief for the battered EU pharmaceutical budgets, achieving spectacular savings almost from the moment the patent expires. The most recent case, already mentioned in a previous post, has been the reduction of the imatinib price in the first tenders after the loss of the patent: 97.5% on the price of the original product (Gleevec). However, experts agree that the case of biosimilars should be different. First, because they are complex drugs whose approval requires a longer and significantly more expensive process than the mere bioequivalence, which makes the list of candidates and therefore competitors much more reduced. In addition, biosimilars must be approved following a centralized process, which means higher costs, while generic manufacturers can select where to enter and focus only on profitable markets. Continuing with the differences, in theory biosimilar products should not be automatically interchangeable, since the trials on which they base their approval have normally been carried out in new patients, not in those under treatment.

The main question remaining is, given the differences noted above, if the change to biosimilars is going to be so automatic and with the same impact on prices as it is with generics. It is also important to know if promotion will be a key factor or if, as it happens with generics, price will be almost the single element to be taken into account.

European governments need to ensure a fast adoption of biosimilars and also a significant price reduction, so an active promotion similar to generics or even stronger can be expected. In some countries, such as the UK, it has already begun by setting biosimilars as treatment of choice for new cases in main therapeutic guidelines. Other countries, such as Germany, will follow soon. However, the interchangeability of patients under treatment remains unclear, since as mentioned above, ethical problems could arise in those who are already stable. Of course, the pharmaceutical companies that manufacture original products are interested in keeping a “reasonable doubt” to defend the brand and it is possible that they can bring many doctors to their side, among other reasons for the risk that it could represent an unlikely but still possible therapeutic failure. However, the rapid adoption of generics in the hospital environment in recent years has shown that the system can be very pragmatic, especially in times of strong need.

With so many opened questions, Emergpharma decided to carry out a study on the biosimilars available in the Top5 EU markets in the period 2016-2019, with the aim to provide a better understanding of the mentioned issues and therefore to help stakeholders to make decisions. Biosimilar approvals are expected to multiply in the coming years, to the point that they are one of the segments with the highest expected growth (above 20% CAGR 2020-2025).

The first molecule reviewed, Rituximab, showed how already the second year after the approval of the first biosimilar these grabbed 50% of the market, although with significant differences between countries: in the UK they reached more than 80%, Germany, France and Italy near the 50%, while in Spain the adoption rate is significantly lower. More information in Biosimilars of Rituximab grab 50% market share in top EU markets after less than 2 years.

This time we focused on filgrastim, whose first biosimilars were approved in 2008 and therefore with a more than 10 years presence in EU markets.The first important finding is that, as showed in the following graph, Neupogen, the original product, barely retains 6.1% of the market share in units.

MS among different biosimilars rates from 42% of Zarzio (Novartis) to the insignificant 1.30% of Ratiograstim (Teva). It is important to mention the evolution of the last approved biosimilar, Accofil (INTAS) that has achieved a 18% market share in just three years. Accord (INTAS) is carrying out a very successful expansion in European markets mainly based on its specialization in a few therapeutic areas, the core one oncology, and in an extremely aggressive pricing policy.

Regarding price erosion, as can be seen in the graph below, filgrastim biosimilar Nivestim (Pfizer) was sold in February 2019 by 0,0189 €/mcg, 7.9% the price of the innovator (Neupogen) at launch time. One of the important innovations provided by Emergpharma's report is that the analysis is performed by taking real data taken from selected hospital tenders instead of usual sell-in data coming from main data panels .

It is also important to note that Neupogen had already reduced its price by 85.7% four years after the first biosimilar was launched, presumably not to be put out of the market.

A third outcome that should be mentioned is that the use of filgrastim in recent years has increased considerably, as can be seen in the following graph.

We do not have evidence that the launch of biosimilars and the significant price reductions are the only reasons of this growth, but the oncologists consulted mentioned that the reduction in price and the consequent lower pressure would have had a great influence on the decision to add filgrastim to certain treatments.

It looks like the adoption of biosimilars seems to follow parameters very similar to those for generics, at least in these two molecules reviewed. After 2 years about 50% of patients can be expected to be treated with biosimilars (rituximab) and at 10 years about 94% (filgrastim). Looking to these figures, it could be said that specialists do not have too many problems in changing treatments.

On the other hand, price reductions are more modest at the beginning (20-25% at two years), while after ten years and in certain tenders (Spain) reached 93%, figures also similar to those we are used to see with generics. However, it will be necessary to see what happens with other products from different categories such as anti-tnf or insulins.

Finally, it seems that in certain molecules biosimilars approval could drive to an increase on the use probably due to greater accessibility to the drug linked to the price reduction. This effect doesn't happen in the case of rituximab at least in the first 2 years, so additional data will be necessary to explain in which cases and why.

Although these are very preliminary data, we can guess that pragmatism will work over other concerns. The desperate need to generate savings to afford new treatments and the overall perception that biosimilars are safe, plus probably the fact that hospital environment is safe and controlled are boosting the use of biosimilars and speeding up the adoption curve. At the same time, when the number of competitors raise, prices also enter into war with rules not different than the ones we have seen before in generics. These, if confirmed will be important premises for companies manufacturing or selling biosimilars at the moment to design their strategy.

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