Biosimilars – a Painless Way of Cutting Costs
Abstract
Approximately 30% of new innovative medicinal products and about 40% of innovative medicinal products in pre-authorisation clinical development are biotechnology-derived medicinal products. The costs of biologicals are increasing rapidly. This trend will continue in the coming years and will threaten the sustainability of pharmacotherapy. The rising costs are due to the lack of competition on the market. Biosimilars are close copies of original biological medicinal products. They have been shown to reduce the price level of biologicals and increase their availability.
The patent- and data protection of the current best-selling biologicals have expired or will be expiring in the near future. The first biosimilars of infliximab and insulin glargine have been licensed and numerous biosimilars of other “blockbuster” products, such as etanercept, adalimumab, rituximab, trastuzumab and bevacizumab, are in late phases of development. These biosimilars could reduce the costs of pharmaceuticals substantially. The 19 biosimilars that have been licensed in the EU have been shown to be as safe and efficacious as the corresponding original medicinal products.
The development of biosimilars is based on the comparability concept. Demonstration of comparability means that a new version of the active substance of a given biological medicinal product must be shown to be comparable with the previous version of the product before it can enter the market. Comparability studies have been used for more than 20 years to ensure that the quality, safety and efficacy of biological medicinal products remain comparable after manufacturing changes. The comparability of biosimilars and the corresponding original biological medicinal products is demonstrated by extensive comparability testing that includes physico-chemical, structural and in vitro biological tests as well as clinical pharmacokinetic, pharmacodynamic, and, generally, safety and efficacy studies.
A biosimilar that has successfully passed this extensive comparability testing will generally obtain the same therapeutic indications as its reference product provided that the performed clinical trial can address all relevant safety and efficacy concerns related to the other, non-tested, therapeutic indications and patient groups and that the physico-chemical, structural and in vitro functional tests have demonstrated comparability.
The interchangeability of biosimilars and their reference products is a controversial issue. From the scientific point of view, there is no reason to expect adverse effects in switching between two comparable products. The examples of switch-related immunogenicity and adverse effects come from situations where the new version of the product was inferior to the previous version. Such incidents are very rare and are unlikely to happen with biosimilars that have undergone extensive comparability testing.
The uptake of biosimilars on the market has been relatively slow. Some European national regulatory authorities have taken positions supporting interchangeability under the supervision of a physician whereas position papers published by European learned societies are often less supportive. The reasons for the different positions are not clear but one factor is definitely the failure to distinguish between the development concept of a product containing a new active substance and the development of a biosimilar. A common factor of all position papers of learned societies is the desire to maintain the gatekeeper role of the prescribing physician in selecting the brand of the medicinal product for their patients. In the current situation, the prescriber will inevitably become responsible not only for the wellbeing of his or her patients but also for the sustainability of the health care system and for the availability of new, more effective and safe medicines in the future.
Authors
Pekka Kurki, Tuomas Oravilahti, Jaana E Martikainen
Additional Information
- Peer-Reviewed: yes.
- Open Access: no.
- Cite as: Kurki, P., Oravilahti, T., & Martikainen, J. E. (2016). Miksi biosimilaarit kannattaa ottaa käyttöön? Suomen lääkärilehti, 71(3), 147–151.
https://www.laakarilehti.fi/tieteessa/katsausartikkeli/miksi-biosimilaarit-kannattaa-ottaa-kayttoon/
