At the moment, EU physicians seem much more comfortable than their US colleagues to prescribe a biosimilar drug, with several EU country strategies and certain incentives in place, encouraging biosimilar use. However, biosimilar prescribing rates in the EU are still very low, especially when related to patients that are already using a biologic drug.
What exactly is a biosimilar?
Biosimilar drugs, or biogenerics, are made from living microorganisms taken from plant or animal cells and are highly similar to approved biologic drugs. However, because of the great variability of living molecules, biosimilar products cannot be identical with the originator biologic, in the same way, that the generic drugs are.
Biosimilars are investigated in clinical trials where their efficacy, safety, and immunogenicity profile is expected to be comparable to the results of the reference product for the same indication.
Current market landscape in the EU
The first biosimilar-Omnitrope (somatropin)- entered the market in 2006. Since then an increasing number of them have been approved. Until today, 77 biosimilar drugs are available for patients in the EU, while many are currently under evaluation, most of them targeting cancer indications.
Why choose a biosimilar?
Biosimilars’ clinical performance is similar to the reference biologic, with no major differences expected. The clinical studies that support the approval of a biosimilar confirm that any differences observed do not have an effect on safety and efficacy.
Furthermore, biosimilars are much less costly than originator products- usually 10% to 30% lower, and when discounts are taken into account as well, the difference could be as high as 70%.
Additionally, biosimilar products do not have to undergo the same clinical processes as the originator in order to obtain approval, and they usually do not require high costs for marketing campaigns and market access. The new biosimilars that are entering the market could result in further price cuts in the future.
By providing more treatment options for each patient, biosimilars have the potential to increase competition in the market and expand access to essential medicines. They can potentially help patients reduce their healthcare costs without compromising on treatment standards, with this having a major impact on the healthcare system as a whole, as it can create cost-saving opportunities for payers, employers, and governments all over the globe.
Current strategies to enhance biosimilar uptake in the EU
Several EU countries have implemented certain strategies in order to encourage their physicians to start prescribing biosimilar drugs. According to Moorkens et al. (2017), in Austria, when there are several treatment options available, the physicians are called upon to prescribe the drug which is most cost-effective. In Belgium, Germany, and Sweden, biosimilars belong in the quotas for prescribing low-cost medicines. In the UK, NHS England offers providers 1% of the contract value of biosimilars to physicians, if they start 90% of new patients on a biosimilar. The same analysis is also providing details on certain limitations in prescribing biologics in certain EU countries. For example, in the Netherlands, there is a limitation of prescription of the reference product, imposed by insurance companies, once the biosimilar has become available. According to the publication by Sarnola et al. (2020), in Sweden and the UK, there are also profit-sharing agreements that allow the clinic or the organizations to have a part of the biosimilar savings. Additionally, in France, there is pharmacist-led substitution of biologic medicines that can also help enhance the uptake of biosimilars. There are also specific strategies that are targeting patients. UK and France have projects in place in which the patient has economical benefits and rewards related to the hospital expenditures, encouraging the use of biosimilar medication.
Prescribing rates
Despite the several incentives currently in place, the physicians’ attitudes towards biosimilars vary. According to Sarnola et al (2020), most physicians seem to prefer the original biologic products, as they believe are superior in efficacy, safety, and immunogenicity compared to the biosimilar version. The main advantage of prescribing biosimilars, according to the results of this analysis, is their low cost.
Measures to support the physician uptake
Certain measures can be taken at a national level or by pharmaceutical companies to further increase the physician preference towards biosimilars. These include:
- Educational programs that could increase physician awareness on the overall value of biosimilars, enhancing their confidence in biosimilar adoption
- Monitoring tools that help them track the drug’s clinical efficacy in real-time, which are thought to be likely to help healthcare professionals feel more comfortable when prescribing them
- Policies and country recommendations supporting the switching and substitution of biologic medicines could certainly reduce barriers in prescribing a biosimilar
- The cost-effectiveness aspect is extremely important, and physicians should be educated on the cost-implications that biosimilar use has for patients and the healthcare system
- More analytical and real-world data are needed in order to provide more evidence that could enhance physician trust and extend the biosimilar use
- Regulatory agencies should start sending physicians concise updates regarding the approved biosimilars, without expecting them to visit their official websites
The future
The number of biologic patent expiries in the following 4-5 years is going to increase dramatically, representing a major opportunity for biosimilar growth. New biosimilar products coming into the market are going to shake the current pharmaceutical landscape of the EU, which is expected to remain the global leader in the biosimilar space. Meanwhile, the North American and Asian biosimilar markets will gradually begin to rise as well.
There is a lot that physicians need to learn in order to overcome widespread misconceptions and understand that by prescribing a biosimilar they are not compromising on treatment standards. Healthcare professionals should feel comfortable starting a treatment-naive patient on a biosimilar or switching a patient to a biosimilar if they consider it appropriate. They have the potential to play a very important role in reducing healthcare costs and solving healthcare challenges, and changing physicians’ mindset towards biosimilar use is essential to contribute in that direction.
#biosimilars #marketaccess #biologics
Sources
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7228507/
https://www.fiercepharma.com/changing-biosimilar-landscape-2020-and-beyond
https://www.pharmexec.com/view/bringing-biosimilars-to-market-in-europe
https://biosimilarscouncil.org/wp-content/uploads/2020/06/EuropeBiosimilars_June_2020.pdf
https://pubmed.ncbi.nlm.nih.gov/29284064/
http://gabi-journal.net/biosimilars-markets-us-and-eu-compared.html
https://www.pharmexec.com/view/us-biosimilar-uptake-challenges-and-the-quest-for-cost-savings
https://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe