A study of patients taking biological drugs in New Zealand identifies a number of attributes associated with negative perceptions of biosimilars, including being female, seeking information online, and preferring innovator drugs .
Biosimilars firms BioFactura and Alvotech announce the start of clinical trials for their Stelara (ustekinumab) biosimilars, named BFI-751 and AVT04, respectively.
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 . However, despite their approval, effectiveness and safety data in IBD remains scarce, according to authors from the UK and The Netherlands .
Biosimilars have been marketed in the European Union (EU) for 13 years. Due to uncertainties about substitutability and interchangeability, their commercialization has been criticised.
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 .
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.
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 .
Development of biologicals has experienced steady growth over the past three decades. Expiration of patents on many originator biologicals, such as insulin, human growth hormone and erythropoietin, has opened the door for the development of biosimilars. The high cost of biologicals, however, has limited their accessibility, particularly in developing countries. Biosimilars offer much-needed affordability and hence improved accessibility. Global health agencies, such as the World Health Organization, are engaged in developing a prequalification program in order to help countries that do not have strong regulatory systems .
Italian local healthcare authorities are highly proactive regarding actions on prescribing behaviour for off-patent biologicals, reveals a study published in GaBI Journal . However, work needs to be done to appropriately reallocate resources gained through patent expiration.
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 . 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 . However, pricing can also play an important role and was investigated by Josep Maria Guiu Segura and Antoni Gilabert Perramon .