Availability of TNF-alpha inhibitor biosimilars in Southern European markets led to lowered costs within the drug class, even after an increased consumption volume for these therapies.
Although biological medicines have revolutionized care for patients diagnosed with immune-mediated inflammatory conditions, the development and manufacturing process of these therapies are more expensive compared with chemically synthesized therapies. The market access of biosimilars, which comply with the same quality, efficacy, and safety standards as originator biologics, represent a cost-savings opportunity.
A new study sought to capture market dynamics following the availability of tumor necrosis factor-alpha (TNF-alpha) inhibitor biosimilars in Southern Europe (Italy, Portugal, Spain). First, the authors conducted a literature review to describe aspects specific to the immunomodulators and TNF-alpha inhibitors market in Southern Europe.
The scientific databases PubMed/Medline, Embase, and Google Scholar were searched up to April 2022. Other literature repositories within websites of Spanish, Italy, and Portuguese health institutions were also included in the literature review.
After the review was concluded, the authors used the findings to conduct a quantitative analysis of market data for TNF-alpha inhibitors and competing immunomodulator molecules in Southern Europe. The study included 16 molecules: adalimumab, abatacept, anakinra, apremilast, baricitinib, certolizumab pegol, etanercept, golimumab, infliximab, ixekizumab, rituximab, secukinumab, tocilizumab, tofacitinib, ustekinumab, and vedolizumab.
The growth of the market (fold change in consumption volume) for TNF-alpha inhibitors was investigated from 2017-2020, and the evolution of consumption volume for each marketed TNF-alpha inhibitor product was compared, as well as the whole class of drugs in the 3 countries of study. This timeframe allowed the analysis to encompass market dynamics pre- and post-availability of TNF-alpha inhibitor biosimilars.
The study notes that the National Health Services’ (NHS) expenditure associated with the purchase of on-patent biologics and immunomodulators in Southern Europe has increased in recent years. The availability of biosimilars has been “instrumental,” according to the authors, in reducing spending in immunology.
Despite the opportunity biosimilars hold in reducing spending, previous research in the study countries found a sub-optimal market environment of off-patent biologics and biosimilars. This is partly reflected in the low-uptake for TNF-alpha inhibitor biosimilars in regions where NHS costs associated to originator molecules have been higher than biosimilar costs.
Additionally, the study observed high intra-country heterogeneity in biosimilars use for the molecules of the study. After the availability of TNF-alpha inhibitor biosimilars, up to 87.3% and 91.1% regional variation in biosimilars uptake was observed for Italy and Spain, respectively. The authors note that this variability may be associated with the decentralized nature of health care competences, and to the design of biosimilar policies at the regional and local level.
In terms of consumption volume, TNF-alpha inhibitor products have increased in recent years (1.15-fold increase in Italy, 1.29-fold increase in Portugal; 1.34-fold increase in Spain). This equates to an expansion in the overall access to TNF-alpha inhibitor pharmaceuticals. Although adalimumab and infliximab still dominate the TNF-alpha inhibitors market in all countries studied, there has been an evolution in trends in favor of the use of on-patent TNF-alpha inhibitors (ie, Cimzia, Simponi), even after biosimilar availability, according to the study.
Following the availability of TNF-alpha inhibitor biosimilars, the market presence of adalimumab-containing products increased with respect to other TNF-alpha inhibitor molecules. In Italy for example, the volume share of adalimumab increased by 5.3% in the first year of an adalimumab biosimilar being available.
In Portugal and Spain, a similar trend was seen, though less pronounced. Comparatively, the market availability of etanercept biosimilars did not lead to a higher utilization, in part due to shifts in utilization trends toward on-patent market competitors, according to the study.
Furthermore, the study found that NHS expenses associated with infliximab- and adalimumab- containing products were lower in 2020 with respect to 2018, despite a sustained increase in consumption volume. This demonstrates that savings were generated within the NHS despite expanded access to TNF-alpha inhibitor therapies.
Specifically, in Italy and Portugal, the year percent decrease in expenditure on adalimumab following the entry of biosimilars was 55% and 43%, respectively. This decrease was seen despite a percent units increase in adalimumab use of 25% in Italy and 14% in Portugal.
Overall, the availability of TNF-alpha inhibitor biosimilars in Southern European markets led to lowered NHS costs within the drug class, even after an increased consumption volume for these therapies.
However, “the potential of marketed TNF-alpha inhibitor biosimilars to generate price competition outside their drug class has been limited. This limitation becomes especially relevant in the context of observed drug utilization shifts towards on-patent and less-affordable therapies…” the authors wrote.
In summary, the need for policies that not only seek higher utilization of “best-value” biologics, but also support sustainable development of new biosimilar molecules is essential, the investigators concluded.
Lacosta T, Vulto A, Huys I, Simoens S. Evaluating the benefits of TNF-alfa inhibitor biosimilar competition on off-patent and on-patent drug markets: A Southern European analysis. Front Pharmacol. 2022;13. https://doi.org/10.3389/fphar.2022.1031910