Biosimilars/Research
Switching to biosimilars safe and effective in IBD patients
Multiple adalimumab biosimilars are now approved for use in inflammatory bowel disease (IBD). In fact, to date, 29 June 2021, there are 10 adalimumab biosimilars approved in Europe [1]. However, despite their approval, effectiveness and safety data in IBD remains scarce, according to authors from the UK and The Netherlands [2].
Biosimilars in Spain: balance between innovation and health public expenditure
Biosimilars have been marketed in the European Union (EU) for 13 years. Due to uncertainties about substitutability and interchangeability, their commercialization has been criticised.
Regulatory landscape for similar biotherapeutic products in Latin America
Most Latin American countries are in the process of or have already established their own regulatory guidelines for similar biotherapeutic products (SBPs), and there are regional recommendations on how to ensure the safety and efficacy of biosimilars.
Biosimilars in Japan: an overview
No regulations on interchangeability exist in Japan and switching between a reference product and biosimilar is often impractical, according to a letter recently published in The Lancet Oncology [1].
Biosimilar epoetin in the US – barriers and recommendations
A review of biosimilar epoetin, which is used to treat cancer and chemotherapy-induced anaemia, shows variable uptake in the US. The authors conclude that safety and pricing considerations are the primary determinants of uptake and make recommendations to increase usage [1].
Regulatory challenges with biosimilars
The World Health Organization (WHO) Expert Committee on Biological Standardization adopted guidelines for biosimilars at its 60th meeting in October 2009 [1]. Since then, according to authors from regulatory bodies across the globe, WHO ‘has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices’.
Local level biosimilar prescribing proactivity revealed in Italy
Italian local healthcare authorities are highly proactive regarding actions on prescribing behaviour for off-patent biologicals, reveals a study published in GaBI Journal [1]. However, work needs to be done to appropriately reallocate resources gained through patent expiration.
Measures to promote the use of biosimilars
How to increase the uptake of biosimilars is an important issue both in Europe and across the world. Europe, via its centralized European Medicines Agency (EMA), has been very successful in approving biosimilars. There are currently 73 biosimilars approved in Europe, almost all of which were marketed immediately after approval [1]. Despite the success in approving and marketing biosimilars, the uptake of biosimilars does vary between different countries in Europe. To encourage the use of biosimilars, targets and incentives have been used across Europe [2]. However, pricing can also play an important role and was investigated by Josep Maria Guiu Segura and Antoni Gilabert Perramon [3].
Prices for arthritis biologicals in Latin America
Analysis of the prices of biological and biosimilar drugs used to treat rheumatoid arthritis suggests these drugs are more accessible in Spain than in Latin America, but least affordable in the US [1].
New data on adalimumab biosimilars from Samsung Bioepis and Boehringer Ingelheim
Recently published data show that switching to Samsung Bioepis adalimumab
biosimilar Imraldi is safe and effective, while data from Boehringer Ingelheim suggest their adalimumab biosimilar, Cyltezo, could be classed as interchangeable.
