Demand for similar biotherapeutic products in Latin America

Biosimilars/Research | Posted 02/07/2021

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 [1].

Competition from biosimilars drives price reductions for biologicals in France

Biosimilars/Research | Posted 15/10/2021

The US has experienced a policy debate as to whether competition from biosimilars is the best strategy for achieving price reductions for biologicals or, rather, whether direct price regulation after loss of patent exclusivity would be more effective. In order to investigate this issue, authors from the US and France combined quantitative and case study methods to examine in detail the interaction between market and administrative mechanisms to reduce biologicals’ prices in France. In their article they present comprehensive data on market shares and prices for three major biologicals and their 11 competing biosimilars between 2004 and 2020 [1].

Positive trial results for bevacizumab copies from Betta Pharmaceuticals and Biocad

Biosimilars/Research | Posted 15/10/2021

The bevacizumab copy biological MIL60 (Betta Pharmaceuticals Ltd) and non-originator biological BCD-021 (Biocad) have demonstrated clinical equivalence for the treatment of non-squamous non-small cell lung cancer (NSCLC) in phase III trials.

Candidate trastuzumab biosimilar AryoTrust

Biosimilars/Research | Posted 08/10/2021

Biologicals are one of the interesting and effective treatment options which can save the lives of many patients, however, their high cost and restricted access for some patients remains a challenge. The emergence of biosimilars, with their similar efficacy and safety profiles, could be a solution for this hurdle. According to the European Medicines Agency (EMA) guidance entitled ‘Biosimilars in the EU – information guide for healthcare professionals’, a biosimilar is ‘a biological medicine highly similar to another biological medicine already approved in the EU’ [1]. Biosimilars are required to have the same standards of pharmaceutical quality, safety and efficacy as for originator biologicals in order to obtain marketing authorization. Although, according to the EMA guidance ‘approval of biosimilars builds on existing scientific knowledge on safety and efficacy of the reference medicine gained during its clinical use, so fewer clinical data are needed’ [2].

Barriers to biosimilar prescribing incentives in Spain

Biosimilars/Research | Posted 08/10/2021

Incentives contribute to the proper functioning of the broader contracts that regulate the relationships between healthcare systems and professionals. Likewise, incentives are an important element of clinical governance understood as healthcare services’ management at the micro-level, aimed at achieving better health outcomes for patients.

Canada’s biosimilar substitution policy: effects on competition and patient safety

Biosimilars/Research | Posted 01/10/2021

A critical review of Canada’s biosimilar substitution policy [1] finds that the scheme has focused on economic factors over other elements such as therapeutic efficacy and market competition. The authors suggest that Canada could learn from the European market, where switching policies retain choice for physicians and patients and promote competition. 

Multiple successive switches between infliximab biosimilars in IBD

Biosimilars/Research | Posted 01/10/2021

Recently, biosimilar tumour necrosis factor (TNF) antagonists have become available and are being increasingly used in treating inflammatory bowel diseases (IBD), Crohn’s disease (CD) and ulcerative colitis (UC). The first infliximab biosimilar to receive approval was CT-P13 (Remsima) based on data from rheumatoid arthritis and ankylosing spondylitis, followed by extrapolation to other indications of originator infliximab (Remicade). The second infliximab biosimilar, SB2 (Flixabi), received authorization based on a pharmacokinetic study in healthy volunteers and a study in rheumatoid arthritis [1].

Different approaches to the interchangeability of biosimilars

Biosimilars/Research | Posted 05/03/2021

The interchangeability of biosimilars can sometimes be an emotive subject. Despite reservations by prescribers, payers and patients, many countries have implemented policies allowing for the substitution of biologicals with biosimilars. However, there is still a lack of harmonization around the world when it comes to how different countries or regions approach the interchangeability of biosimilars [1].

Federal purchases of biological drugs for cancer in Brazil

Biosimilars/Research | Posted 24/09/2021

Buying biosimilars is generally considered to be a way to increase access to cancer treatments in public health services. In Europe, the approval, commercialization and use of similar biotherapeutic products (SBPs) have been encouraged as a way to reduce costs and expand treatment coverage [1, 2]. In Brazil, an analysis of the profile of purchases of monoclonal antibodies (mAbs) acquired by the Unified Health System (SUS) between 2015 and 2019 showed that this premise might not be true in Brazil [2].

Clinical pharmacists have a critical role in increasing biosimilar uptake

Biosimilars/Research | Posted 17/09/2021

The increasing global burden of chronic diseases, including cancers, diabetes, autoimmune disorders, anaemia of chronic renal failure, rheumatoid arthritis, multiple sclerosis, blood disorders and others, underscore the importance of patients’ access to safe and effective treatments. Interestingly, the introduction of biologicals in the 1980s revolutionized the treatment of these chronic diseases with better prognosis, although high costs and limited patient access remain challenges. These biologicals are known by various names, including biopharmaceutical agents, biologicals, biological therapies, biological agents and biological response modifier therapy or immunotherapy. Biologicals are derived or manufactured from a living biological system. With the majority of originator biologicals losing patent protection and the emergence of biosimilars, the landscape of biologicals is facing many changes.