Assessing the Value of Biosimilars: A Review of the Role of Budget Impact Analysis

Abstract

Biosimilar drugs are highly similar to an originator (reference) biologic, with no clinically meaningful differences in terms of safety or efficacy. As biosimilars offer the potential for lower acquisition costs versus the originator biologic, evaluating the economic implications of the introduction of biosimilars is of interest. Budget impact analysis (BIA) is a commonly used methodology. This review of published BIAs of biosimilar fusion proteins and/or monoclonal antibodies identified 12 unique publications (three full papers and nine congress posters). When evaluated alongside professional guidance on conducting BIA, the majority of BIAs identified were generally in line with international recommendations. However, a lack of peer-reviewed journal articles and considerable shortcomings in the publications were identified. Deficiencies included a limited range of cost parameters, a reliance on assumptions for parameters such as uptake and drug pricing, a lack of expert validation, and a limited range of sensitivity analyses that were based on arbitrary ranges. The rationale for the methods employed, limitations of the BIA approach, and instructions for local adaptation often were inadequately discussed. To understand fully the potential economic impact and value of biosimilars, the impact of biosimilar supply, manufacturer-provided supporting services, and price competition should be included in BIAs. Alternative approaches, such as cost minimization, which requires evidence demonstrating similarity to the originator biologic, and those that integrate a range of economic assessment methods, are needed to assess the value of biosimilars.

Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!

“…Our study has illustrated the key benefits in the European off-patent biologics and biosimilars market with practical examples as derived from budget impact analyses, economic evaluations, and other studies. The shortcomings of these studies, such as a limited range of cost parameters, assumptions used to populate the budget impact model regarding hypothetical drug pricing and biosimilars uptake, the limited range of sensitivity analysis, lack of local adaptation and validation of economic studies, have been analyzed in the literature [5] and fell outside the scope of this study. The value of biosimilars may also be different across various regions of Europe.…”

“…Biologics are being used in the treatment of the most serious, life-threatening, and chronic diseases such as cancers [1], immune-mediated inflammatory conditions [2], diabetes mellitus [3], and fertility [4] and are likely to be of use in treating other diseases in the future. However, the clinical benefits of biologic therapy are offset by challenges related to affordability of and accessibility to biologic medicines [5].…”

“…Development of biosimilars is complex because biologics are large and complex molecules derived from living cells by a complex manufacturing process. However, once assessed and licensed by an advanced regulatory agency, no meaningful difference between originator biologics and biosimilars is expected with respect to quality, safety and efficacy [5,6]. Biosimilars are marketed following expiration of patent and exclusivities of the originator biologics.…”

A simplified techno‐economic model for the molecular pharming of antibodies

“…Regardless of the platform, bulk drug prices will probably remain high for new products due to the need to recoup the cost of clinical trials and regulatory approval. However, once the products come off patent, costs could be substantially reduced if changing the platform (from mammalian cells to plants) does not require a full series of new clinical tests to prove equivalence, and allows the better scalability of plants to be exploited in the generics market (Simoens, Jacobs, Popovian, Isakov, & Shane, ). There is also the possibility to reduce margins by free technology transfer to developing countries (Ma et al, ).…”

Tendering and biosimilars: what role for value-added services?

“…Biosimilars are biological products that are highly similar to an already licensed biologic, with no clinically meaningful differences in quality, efficacy, or safety [9][10][11]. The development program for a biosimilar is more tailored, but nevertheless just as rigorous as for a new biological medicine [12]. Since the approval of the first biosimilar to somatropin in 2006, over 50 biosimilars have been authorized by the European Commission for use in the EU, spanning a variety of biologic classes and a broad range of disease indications [13].…”