There are more than 45 biosimilars approved in Europe across a range of diseases in oncology, autoimmune disorders, diabetes and fertility[1]. The introduction of biosimilar antibodies, beginning with the approval of the first infliximab biosimilar in 2013, has been particularly game-changing due to their capacity to increase competition and significantly decrease the economic burden associated with autoimmune diseases such as rheumatoid arthritis.

By increasing competition, biosimilar medicines offer the potential for savings of up to €2 billion annually across the EU[2]. However, there is a high variation in biosimilar use and payer decision drivers across Europe, which may impact the savings that can be achieved through competition between originator biologics and biosimilars. For example, the uptake of infliximab biosimilars varied from ~90% in the UK to ~50% in France, Germany, and Spain in 2018[3].

Maximising the cost-saving potential of biosimilars remains a topic of much interest to payers and policymakers. At the recent ISPOR EU conference in Copenhagen, there were almost 100 presentations and posters focused on biosimilars. Despite the first biosimilar being approved in Europe well over a decade ago (somatotropin, in 2006), a challenge that continues to persist for payers is physician reluctance to prescribe biosimilars. This is typically either due to a lack of knowledge, or clinical concerns. This news article explores the issue in further detail.

A lack of physician awareness and confidence in biosimilars remains a significant issue for policymakers

Remap Consulting recently engaged in discussions with payers in Germany and France to understand opinions on current biosimilar policies, and barriers to increased biosimilar uptake. Despite the higher rate of adalimumab biosimilar uptake in 2018/19 compared to infliximab and etanercept (launched in earlier years) in both countries, payers continue to see physician hesitancy to prescribe biosimilars as a significant hurdle to greater biosimilar market share.

In France there are two distinct markets for biosimilars: 1) hospital-prescribed and dispensed drugs (e.g. infliximab), and 2) hospital or retail-initiated, retail-dispensed drugs (e.g. etanercept and adalimumab). Retail physicians are a key stakeholder for market 2), with the freedom to prescribe either the originator or biosimilar and no clear incentives encouraging them to favour the biosimilar. Largely in contrast to their counterparts in hospitals, retail physicians continue to lack confidence in biosimilars. Indication extrapolation (where a biosimilar is approved in multiple indications based on one Phase III clinical study in a single indication) and deficiencies in biosimilar clinical data packages (e.g. a lack of French patients in clinical studies) remain concerns, likely driven in part by messaging from originator manufacturers. Physicians are particularly reluctant to switch patients currently stable on the reference product and fear culpability for any safety and efficacy issues that may result from the switch. Route of administration is also important: switching is more straightforward for an IV-delivered hospital drug, where patients are less aware of the drug they are receiving and there is less need for physicians to engage in a challenging conversation.

In Germany, biosimilars have been an area of recent focus for the Health Ministry, with automatic substitution proposed as part of the draft GSAV law. Payers consider physician acceptance of biosimilars to be generally increasing, but that there is still some variation by geographic region, device and therapy area. As in France, indication extrapolation remains a concern, particularly for oncologists. Originator messaging is likely to be a continued driver behind efficacy, safety and quality concerns around biosimilars.

The issues above are not confined to France and Germany. In a recent systematic literature review exploring stakeholders’ opinions, behaviours, and views on biosimilars across the EU[4], it was evident that there are still several misconceptions regarding biosimilars and their degree of similarity compared to the reference products. In a similar such review that also included the US[5], most surveyed physicians had an incomplete or only basic awareness of biosimilar medicines, with familiarity higher among hospital-based than office-based practitioners. Both US and EU physicians were largely unaware of biosimilars as safe and effective treatment options, restricting them to biologic treatment-naïve patients only. In a recent presentation on biosimilar uptake in Central Eastern European (CEE) countries[6], it was highlighted that in many cases physicians did not even try the more affordable off-patent biologics for new patients.

The result of these physician knowledge gaps and concerns is that in countries lacking ‘hard’ policy measures to mandate biosimilar uptake (such as single-winner tenders or prescribing quotas), biosimilar uptake remains sub-optimal where physician input is maintained in the decision process. France provides a good example of this. Biosimilar infliximab (a hospital product, with uptake strongly encouraged by single-winner tenders) penetration was ~50% two years after launch, compared to ~20% in the same time period for etanercept (primarily a retail product)[7].

Implications for manufacturers

While physician acceptance of biosimilars is likely to further increase with time, there remains an opportunity for biosimilar developers to work with payers to provide effective educational materials to expedite the process. Collaborating with well-regarded physicians and medical societies is likely to be the most effective channel to encourage physician confidence through peer-to-peer interactions. Physicians tend to pay less regard to sales reps.

A focus should be placed on the fact that cost savings achieved through biosimilars will provide greater patient access to expensive innovative drugs; this message is likely to resonate particularly well with oncologists. In addition, company reputation continues to be a factor that can be leveraged to reassure stakeholders around potential quality and supply issues.

Finally, payers should be further encouraged to introduce effective prescribing incentive measures to drive a change in physician behaviour. Such schemes are becoming more widespread, but perhaps more of a focus should be placed on the retail market where physician freedom and influence is greater. There is evidence that this is already taking place, with a pilot project introduced in Belgium throughout 2019.

[1] IQVIA, Advancing Biosimilar Sustainability in Europe, 2018

[2] IQVIA, MIDAS 2016

[3] IQVIA, MIDAS 2018

[4] Braoudaki E, Barton P. Resistance to or support of biosimilars’ market penetration? A systematic review of European stakeholders’ behaviors. Presented at: ISPOR Europe 2019; November 2-6, 2019; Copenhagen, Denmark. Abstract PBI58

[5] Leonard E et al. Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review. J Manag Care Spec Pharm. 2019 Jan;25(1):102-112

[6] Inotai A. Biosimilars’ uptake from a CEE perspective – theory vs. practice. Presented at: ISPOR Europe 2019; November 2-6, 2019; Copenhagen, Denmark

[7] Smart Pharma Consulting. Succeeding on the French Biosimilars Market, June 2019