Differences In Pricing Policies For Generic And Biosimilar Medicines

Vogler, Sabine; Schneider, Peter A.; Gombocz, Margit; Zimmermann, Nina

doi:10.1016/j.jval.2016.09.021

Cited by 5 publications

(5 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We also identified an abstract (Vogler et al, 2016 ) presenting the results of a survey analyzing the possible differences between pricing policies for generics and for biosimilar medicines in European countries including 25 EU countries (all except Ireland, Italy, and Luxembourg) as well as Albania, Belarus, Iceland, Norway, Serbia, Russia, Turkey, and Ukraine. While 23 of the 33 countries set the price of the generic in relation to the price of the originator, only 13 countries reported to do so for biosimilar medicines.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries

et al. 2017

View full text Add to dashboard Cite

Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries.Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country. Data on the extent of reimbursement of biologic drugs (separately for original products and biosimilars) in the years 2014 and 2015 were also collected for each country, along with data on the total pharmaceutical and total public health care budgets.Results: Our survey revealed that no specific criteria were applied for the pricing and reimbursement of biosimilars in the selected CEE countries; the price of biosimilars was usually reduced compared with original drugs and specific price discounts were common. Substitution and interchangeability were generally allowed, although in most countries they were at the discretion of the physician after a clinical assessment. Original biologic drugs and the corresponding biosimilars were usually in the same homogeneous group, and internal reference pricing was usually employed. The reimbursement rate of biosimilars in the majority of the countries was the same and amounted to 100%. Generally, the higher shares of expenditures were shown for the reimbursement of original drugs than for biosimilars, except for filgrastim, somatropin, and epoetin (alfa and zeta). The shares of expenditures on the reimbursement of biosimilar products ranged from 8.0% in Estonia in 2014 to 32.4% in Lithuania in 2015, and generally increased in 2015. The share of expenditures on reimbursement of biosimilars in the total pharmaceutical budget differed between the countries, with the highest observed value for Slovakia and Hungary and the lowest—for Croatia.Conclusions: The requirements for the pricing and reimbursement of biosimilar products as well as the access of patients to biologic treatment do not differ significantly between the considered CEE countries. Biosimilar drugs significantly influence the reimbursement systems of these countries, and the expenditure on the reimbursement of biosimilars is increasing as they are becoming more accessible to patients.

show abstract

Section: Discussionmentioning

confidence: 99%

“…The Netherlands have been tendering for generics in the outpatient sector during the last decade, but biosimilars have been included in tenders only recently. The authors concluded that European countries tend to apply similar pricing policies for generic and biosimilar medicines (Vogler et al, 2016 ).…”

Section: Discussionmentioning

confidence: 99%

Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries

et al. 2017

View full text Add to dashboard Cite

show abstract

“…The review of literature data shows that the differences between the price of biosimilars and their reference biologic product ranges between 15% and 30%. On the other hand, the difference for generics and originator drugs may be up to 80% [87,88]. A systematic review that was carried out by Tuna et al to identify price difference between biotechnological reference products and biosimilars revealed that the variation differs across European countries between 0.51% and −38%.…”

Section: Critical Challenges Of Biologics and Biosimilarsmentioning

confidence: 99%

The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy

2019

View full text Add to dashboard Cite

The coming wave of patent expiries of first generation commercialized biotherapeutical drugs has seen the global market open its doors to close copies of these products. These near perfect substitutes, which are termed as “biosimilars”, do not need to undergo intense clinical trials for their approval. However, they are mandated to produce identical similarity from their reference biologics in terms of clinical safety and efficacy. As such, these biosimilar products promise to foster unprecedented access to a wide range of life-saving biologics. However, seeing this promise be fulfilled requires the development of biosimilars to be augmented with product trust, predictable regulatory frameworks, and sustainable policies. It is vital for healthcare and marketing professionals to understand the critical challenges surrounding biosimilar use and implement informed clinical and commercial decisions. A proper framework of pharmacovigilance, education, and scientific exchange for biologics and biosimilars would ensure a dramatic rise in healthcare access and market sustainability. This paper seeks to collate and review all relevant published intelligence of the health and business potential of biosimilars. In doing so, it provides a visualization of the essential steps that are required to be taken for global biosimilar acceptance.

show abstract

“…According to literature data the differences between the price of biosimilars and their RBP is between 15 and 30%. Whereas this difference for generics and originator drugs may be up to 80% ( Declerck and Simoens, 2012 ; Vogler et al, 2016 ). Haustein et al (2012) concluded that the use of biosimilars could significantly decrease the healthcare expenditure on biological medicines in EU national markets (2007–2020) of France, Germany, Italy, Poland, Romania, Spain, Sweden, and United Kingdom.…”

Section: Discussionmentioning

confidence: 99%

Comparative Price Analysis of Biological Products for Treatment of Rheumatoid Arthritis

et al. 2018

View full text Add to dashboard Cite

Biological products for treatment of rheumatoid arthritis usually are cost effective for healthcare systems in Europe, but they are huge financial burden due to the high number of patients and the significant budget impact. The expected saving from introduction on the market of biosimilars are significant and are linked to better access and affordability. The aim of this study was to conduct comparative price analysis of biological products for rheumatoid arthritis therapy among seventeen EU countries. The point of view is that of the Bulgarian pricing and reimbursement system and the chosen countries are those from external reference basket for prices comparison at manufacturing level. All authorized biological products by EMA with therapeutic indication rheumatoid arthritis were selected. The access for treatment is evaluated as the availability of the product on the market and the prices level. We assessed the availability of all trade names in the price lists of the observed countries. The prices data was obtained from the official web pages of the responsible institutions up to date December 2017. The results show that four out of all six INNs have authorized biosimilars in EMA. Despite its earlier authorization biosimilar adalimumab is not present in any of the price lists of countries. From all eighteen countries only in Lithuania and Estonia there were no published prices of any of the selected medicinal products. Countries with higher number of biosimilar prices are Spain and France. Differences in manufacturers’ prices of reference biological products in selected countries in comparison with the lowest manufacturer price are higher with 22 to 69% while the retail prices between 62 and 95%. Differences are mostly notable for rituximab, and less notable for tocilizumab. Manufacturers’ and retail prices of biosimilar products were established only for three INNs (etanercept, rituximab, and infliximab). Manufacturers’ prices differ between 26 and 75%, while retail prices differ between 40 and 92% for biosimilars. Comparison of the differences between manufacturer prices of reference biological product and biosimilars shows 36% difference for etanercept, 39% for rituximab, and 31% for infliximab, while at retail level the differences are 11, 86, and 143%, respectively. The limitation of the study is that the prices are the official ones without discounts due to confidentiality and the real prices may be lower. The second limitation is that the methodology for pricing differs in the countries and this could also influence the prices on both levels (manufacturer and retail). Introduction of biosimilars on the national markets led to significant decrease in reimbursed prices paid by public funds and thus might benefit the patients’ access to biological therapy. The decrease of prices after biosimilars entrance on the market is not as notable as for commodity generics.

show abstract

Differences In Pricing Policies For Generic And Biosimilar Medicines

Cited by 5 publications

References 0 publications

Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries

Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries

The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy

Comparative Price Analysis of Biological Products for Treatment of Rheumatoid Arthritis

Contact Info

Product

Resources

About