Understanding the rules on biosimilar reimbursement policy


Biosimilars are defined by the European Medicines Agency as high-quality biological drugs that are highly similar to and show no clinically meaningful differences from an existing and approved therapeutic drug, in terms of safety, purity, and potency.1,2 The development and production of biosimilars in healthcare have been regulated in the European Union (EU) since 2005, and in the United States since 2009.3,4,5

Healthcare reimbursement is the payment made to healthcare professionals (HCP) and facilities by governments or health insurers in exchange for their medical service. These services, also referred to as reimbursement mechanisms, can be in the form of salaries paid for HCP, fee-for-service (quantity of service provided), capitation (tax), pay-for-performance (quality of service provided), or diagnosis-based payment (diagnosis-related groups).6

Regulating the use of biosimilars includes establishing efficient and practical reimbursement policies.

Challenges to Having A Uniform Biosimilar Reimbursement Policy

Most countries have different biosimilar reimbursement regulations depending on the reimbursement mechanism adopted, the therapeutic area in question, and the authorities responsible for monitoring the use of biosimilars.7 This difference could also be extended to the roles of the regulatory bodies, which are responsible for providing a framework for biosimilar approval and reimbursement, in comparison to those of the pharmacists who deal with the practical considerations such as naming, indication extrapolation, and some level of reimbursement.4

Regulating Biosimilar Reimbursement in Europe

The European Biopharmaceutical Enterprises conducted two large surveys to study the pricing and reimbursement policies that are used for off-patent biologicals (biosimilars) in different European countries.8,9

In all European countries (EU member states, plus Iceland, Norway, Russia, Turkey, and Serbia), national authorities are responsible for biosimilar reimbursement, where regional (local councils) budgets can be involved, as in Italy, England, and Russia.7 For example, in England, different commissioners are responsible for reimbursing different therapeutic classes of biosimilars: National Health Service England reimburses biosimilars of cancer drugs whereas clinical commissioning groups reimburse biosimilars of TNF-alpha inhibitors. In Russia, individual councils are authorised to create their own biosimilar reimbursement programme, supplementing the national programme.7

Most European countries allow the reimbursement of biosimilars for all the indications authorised by their healthcare authorities, irrespective of the indications concluded from the original clinical trial.7 However, whilst countries such as Croatia and Serbia apply this rule directly, others may apply certain restrictions. For example, in Malta, second line biosimilars can only be reimbursed if the first line treatment has failed, whereas in Bulgaria, the indications can only be deemed valid if they were based on the International Classification of Diseases code10 and marketing authorities, in ambulatory care and hospital setting, respectively.7

Two-thirds of the European countries have an internal reference pricing policy for reimbursing a group of medicines.7,11 Such a policy could result in pricing the originator medicinal product and the biosimilar at the same level, as is the case in Bulgaria, where HCPs are encouraged to prescribe biosimilars for treatment-naïve patients.7 Furthermore, only countries with a generic price link in force are able to price biosimilars at a percentage of the price of their originator drugs.12

Regulating Reimbursement

Biosimilar reimbursement is regulated and updated in most European countries, reflecting the importance and increased entry of these drugs in the healthcare system. However, there is no unified biosimilar reimbursement system among these countries, which might hinder efforts to increase the uptake of biosimilars by patients. To achieve a unified biosimilar reimbursement system, physicians and stakeholders need to be encouraged and educated about the benefits of biosimilars. Furthermore, the use of novel health information technology to design accessible electronic medical records could enhance the effectiveness, accuracy, and feasibility of any reimbursement system.



1EMA. Biosimilar medicines: Overview. European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview. Published September 17, 2018. Accessed March 6, 2019
2Schiestl M, Zabransky M, Sörgel F. Ten years of biosimilars in Europe: development and evolution of the regulatory pathways. Drug Des Devel Ther. 2017;11:1509-1515. doi:10.2147/DDDT.S130318
3European Medicines Agency. Similar biological medicinal products. European Medicines Agency. https://www.ema.europa.eu/en/similar-biological-medicinal-products. Published October 29, 2014. Accessed March 6, 2019
4Stevenson JG, Popovian R, Jacobs I, Hurst S, Shane LG. Biosimilars: Practical Considerations for Pharmacists. Ann Pharmacother. 2017;51(7):590-602. doi:10.1177/1060028017690743
5Government Publishing Office. Public Law 111 - 148 - Patient Protection and Affordable Care Act - Content Details - PLAW-111publ148. https://www.govinfo.gov/app/details/PLAW-111publ148/PLAW-111publ148. Accessed March 6, 2019
6Britton JR. Healthcare Reimbursement and Quality Improvement: Integration Using the Electronic Medical Record. Int J Health Policy Manag. 2015;4(8):549-551. doi:10.15171/ijhpm.2015.93
7Moorkens E, Vulto AG, Huys I, et al. Policies for biosimilar uptake in Europe: An overview. PLOS ONE. 2017;12(12):e0190147. doi:10.1371/journal.pone.0190147
8European Biopharmaceutical Enterprises. What pricing and reimbursement policies to use for off-patent biologicals? – Results from the EBE 2014 biological medicines policy survey - GaBI Journal. http://gabi-journal.net/what-pricing-and-reimbursement-policies-to-use-for-off-patent-biologicals-results-from-the-ebe-2014-biological-medicines-policy-survey.html. Published February 25, 2015. Accessed March 6, 2019
9Alexander Roediger, Barbara Freischem, Jean-Baptiste Reiland. What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey. http://gabi-journal.net/what-pricing-and-reimbursement-policies-to-use-for-off-patent-biologicals-in-europe-results-from-the-second-ebe-biological-medicines-policy-survey.html. Published May 8, 2017. Accessed March 6, 2019
10WHO. WHO | International Classification of Diseases, 11th Revision (ICD-11). WHO http://www.who.int/classifications/icd/en/. Published June 18, 2018. Accessed March 6, 2019.
11Generics and Biosimilars Initiative. EBE reveals Europe’s biosimilar pricing and reimbursement policies landscape. http://gabionline.net/Biosimilars/Research/EBE-reveals-Europe-s-biosimilar-pricing-and-reimbursement-policies-landscape. Published February 15, 2018. Accessed March 6, 2019
12Alessandro Curto. Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond. http://gabi-journal.net/trends-and-challenges-in-biosimilars-pricing-and-reimbursement-policies-in-europe-and-beyond.html#R15. Published May 15, 2017. Accessed March 6, 2019