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 .
The World Health Organization (WHO) Expert Committee on Biological Standardization adopted guidelines for biosimilars at its 60th meeting in October 2009 . 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’.
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 .
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 .
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.
US biotechnology company Biogen Idec (Biogen) and China-based Bio-Thera announced on 1 June 2021 positive phase III data for their tocilizumab biosimilar, BAT1806. According to the two companies, ‘the comparative study met its primary endpoints and showed equivalent efficacy and comparable safety profile in patients with moderate-to-severe rheumatoid arthritis’.
Yuflyma (CT-P17) is an adalimumab biosimilar, administered at 100 mg/mL that also has the same citrate-free and high concentration formulation of reference adalimumab. To demonstrate the bioequivalence of CT P17 to reference adalimumab, a randomized, double-blind, active-controlled study in subjects with moderate to severe rheumatoid arthritis (RA) was conducted . The study was designed to demonstrate equivalence of efficacy (ACR20* response rate at Week 24) for CT P17 versus reference adalimumab and to evaluate additional efficacy, pharmacokinetics (PK), usability and safety over one year.