The federal government has decided to boost the market for biosimilars, cheaper versions of biologics. Starting this month, hospitals will be required to award government contracts for biologics within nine months once a biosimilar is available. This should increase competition between manufacturers of biosimilars and original brand-name drugs, thereby reducing health insurance costs.
What are biosimilars?
Biosimilars are drugs made through biological processes that are almost identical to the original product, whose patent has expired. They are not exactly the same because they may have minor differences in structure or purity. But they do have the same action and safety as the reference drug. Biosimilars are used to treat cancer, rheumatoid arthritis, diabetes and chronic intestinal inflammation, among others.
Why are biosimilars important?
Biosimilars are a lot cheaper than the brand-name drugs they are based on. According to Medaxes, the industry association of producers of generic drugs and biosimilars, a biosimilar can be up to 50 percent cheaper than the original. That means big savings for health insurance, which reimburses 1.7 billion euros a year for biosimilars.
What about the biosimilars market in Belgium?
Compared to other European countries, Belgium lags behind in the use of biosimilars. Fifteen years after the approval of a first biosimilar in Europe, Belgium lags behind other European Union countries in biosimilar prescribing. In 2020, the market share of biosimilars in Belgium - with the exception of filgrastim, infliximab and follitropin-alpha - was less than 20%. However, at the beginning of 2022, 34 biosimilars (of 13 reference products) of the 71 biosimilars (of 16 reference products) approved in the European Union were available in Belgium. There are several reasons why biosimilars are not breaking through well in our country. One is that some hospitals do not make sufficient use of public procurement to purchase biologics, which prevents them from gaining a price advantage from the competition between biosimilars and branded drugs.
What changes now?
To stimulate the market for biosimilars, Health Minister Frank Vandenbroucke (Forward) has introduced a new rule requiring hospitals to place a government order for biosimilars within nine months of the launch of a biosimilar. In this way, he wants to ensure that hospitals order more biosimilars and that manufacturers of branded drugs lower their prices to remain competitive. The new rule applies to all biologics for which a biosimilar is available, except for vaccines and blood products.
What are the benefits of this measure?
The new rule aims to save health insurance money by reimbursing cheaper drugs. According to Vandenbroucke, this could eventually save up to €300 million a year. Moreover, it can also improve access to innovative treatments, as it frees up more budget for new drugs that do not yet have a cheaper alternative. Finally, it can also increase the quality of care, because hospitals will have more freedom of choice to choose the most appropriate drug for their patients.
What are the potential drawbacks or challenges?
The new rule may also face resistance from some health care players. For example, manufacturers of brand-name drugs may see their market share decline and profit margins shrink. They may try to protect their products by filing lawsuits or offering discounts to hospitals. Also, some doctors and patients may be reluctant to switch to biosimilars, fearing possible side effects or reduced efficacy. Therefore, it is important to properly inform and sensitize them about the benefits and safety of biosimilars. Finally, practical problems may also arise, such as the availability of enough biosimilars on the market or the administrative burden associated with organizing public procurement.
More on the new legislation
In application of this new legislation, a Royal Decree was promulgated on September 13, 2023, establishing special rules on public procurement of biologics. In a forthcoming blog post, we will elaborate on the sweeping obligations for hospitals in their procurement of biosimilars.
Resources
- https://www.tijd.be/politiek-economie/belgie/federaal/vandenbroucke-duwt-markt-voor-goedkopere-medicijnen-verder-open/10496670.html
- https://monardlaw.be/nl/verhalen/aankoop-van-biosimilars-nieuwe-regels-in-overheidsopdrachten/
- https://www.cbg-meb.nl/onderwerpen/medicijninformatie-originele-biologische-medicijnen-en-biosimilars/extra-medische-informatie-voor-zorgverleners
- https://legalnews.be/overheidsopdrachten/overheidsopdrachten-voor-biologische-geneesmiddelen-kb-van-13-september-2023-legalnews
