1Shereen Abdalfattah Algergawy

1Faculty of Medicine Benha University


The purpose of this review study  is to evaluate the creation and switch from biological to biosimilar in juvenile idiopathic arthritis, mainly in low financial countries.

Biosimilar versions of original biologic agents used in a wide range of chronic inflammatory diseases including  juvenile idiopathic arthritis, the goals of switching from a stable biologic to  biosimilar are cost savings and allow  greater patients access to treatment, especially as they  have  similar clinical responses and safety events. The difference in price between reference and biosimilar products may be more than thirty percent and such cost saving sufficient to generate considerable interest, particularly in developing countries and negative economic.

Material(s) and Method(s):

In one research using the large national database of the German BIKER-registry, the introduction or switching from etanercept  (ETA) and adalimumab (ADA) originators to their biosimilar were studied in children with JIA.

Also in multicenter in Italy, many studies in JIA children treated with biosimilars of ETA or ADA were included. TNF-inhibitor therapy efficacy and safety were assessed during the originator and at 3, 6, and 12 months and after switching   to their respective Biosimilar (BIOs) in pediatric patients.

Treatment is problematic across North Africa, but each country has specific challenges. In Algeria, the state provides free treatment for the entire population, regardless of socioeconomic status, but costs must remain below a specified threshold. In Morocco and Tunisia, patients covered by the social security system are entitled to receive free treatment. However, the number of patients requiring specialist care and biopharmaceuticals affects access, so that a cost reduction of only 20-30% for biosimilar is expected to improve access. Egypt, installed the legal/ regulatory framework for biosimilar authorization to make certain that sufferers and Healthcare professionals (HCPs) are protected.


Based on clinical trials of switching from a biologic to a biosimilar, Similar clinical response and safety events were founded. The ACR white paper on the use of biosimilar in clinical practice suggest that the interchangeability of biosimilar is appropriate in clinical use.

In 2018 Danish National recommendations ordered an obligatory transfer to biosimilar adalimumab for financial motives.

On February 16, 2021, adalimumab biosimilar, Hyrimoz® become launched in Canada and legal on the market in Canada with the aid of using Health Canada on November 4, 2020.  This biosimilar is approved for 9 indications, which includes a polyarticular juvenile idiopathic arthritis.

On March 29, 2021, In Australia, HadlimaTM is approved for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis and  ankylosing spondylitis. 

Present guidelines and regulatory frameworks for biosimilar are being up-to-date in the Middle East, North Africa in accordance to MENA vicinity Regulatory affairs.

 Since European Medicines Agency (EMA) brought a legal pathway for biosimilar approval in 2004. Numerous worldwide agencies, e.g., WHO, MHRA, HC, have issued policies what follows are an outline of present suggestions and regulatory framework for biosimilar in a number of those countries and regulatory suggestions for biosimilar licensing.

 Moreover, posted recommendation on biosimilar is found in Saudi Arabia, Egypt, Lebanon, Jordan, Tunisia and Iraq.

On 23 October, a digital clinical symposium will announce the supply of rituximab biosimilar in Egypt.

This release is amazing information for Egyptian patients, making this crucial remedy extra broadly to them.


Biosimilar can improve patients’ access to quality biological medicines and bring several benefits to healthcare systems.

Introduction and switching to biosimilar is mandatory especially in countries facing a difficult economic situation.