mAbxience | Blog

Influencing factors in
the implementation of biosimilars

A study conducted by the consultancy company GFK on behalf of the European Biosimilars Group analysed the main factors that support a sustainable European biosimilar drugs market (GfK Market Access, 9 September 2014). The study revealed that biosimilar medicines provide a major opportunity with considerable benefits, since they lead to cost savings throughout Europe, contribute to the sustainability of National Healthcare Systems and improve patient access to innovative treatments. However, in order to achieve these benefits in the long term, the biosimilar medicines market must continue to be sustainable.


The study concluded that the main factor influencing the sustainability of the biosimilar medicines market and enabling biosimilar drug implementation is that this market must be attractive and deliver continuing benefits, in both the short and long term, to the four key stakeholder groups: physicians, payers, patients and industry. However, the study emphasises that the “attractiveness” and “benefit” concepts are different in each of these groups. In this way, for physicians it involves having more opportunities to treat more patients with appropriate therapies. For payers, it entails cost savings and the financial sustainability of healthcare systems. For patients, it means having improved access to medicines. Finally, for the industry, it involves a reasonable return on investment with the continued attractiveness of R&D investment in new medicines development.


On the other hand, other factors that strongly influence the development and implementation of biosimilars include the prescribing physician’s trust, the complexity of clinical development and the uncertain regulatory framework. In order to increase the prescribing physicians’ trust, they must have a good understanding of biosimilars. In fact, as we already stated in a previous post, the consultancy company PwC (PricewaterhouseCoopers) revealed that only 17% of survey respondents chose the correct biosimilar definition from a list provided (PwC Health Research Institute, Top Issues Consumer Survey, 2015). Therefore, a series of training programs have been established providing clear information about them, including courses, discussion forums, conferences and newsletters. The complexity of clinical development is another important factor because it has a direct impact on obtaining marketing authorisation approval from regulatory authorities, such as the Food and Drug Administration (FDA) in the Unites States, and the European Medicines Agency (EMA) in Europe. The more complex a drug’s clinical development is, the more time is required to obtain the marketing authorisation and the longer it takes to implement it. Finally, the legal framework regulating the development, approval, marketing and implementation of biosimilars, depending on the country, is quite uncertain and vague. However, it is true that Europe has been pioneering in the establishment of a legal framework and guidelines for the approval of biosimilars. In fact, the Spanish Ministry of Health, Social Services and Equality published the Price Referencing Order (SSI/1305/2016) in Spain’s Official State Gazette (BOE) which marks the introduction of biosimilars into the health system.