Recommendations on the use of Biosimilars by the Brazilian Society of Rheumatology, Brazilian Society of Dermatology, Brazilian Federation of Gastroenterology and Brazilian Study Group on Inflammatory Bowel Diseaseâ€â€Focus on clinical evaluation of monoclonal antibodies and fusion proteins used in the treatment of autoimmune diseases

The Journal focuses on Biosimilars, Autoimmune diseases, Rheumatoid arthritis, Ankylosing spondylitis, Psoriasis, and Crohn's disease. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. An autoimmune disease is a condition arising from an abnormal immune response to a normal body part. Rheumatoid arthritis (RA) is an autoimmune disease that can cause joint pain and damage throughout your body. Ankylosing spondylitis is an inflammatory disease that, over time, can cause some of the small bones in your spine (vertebrae) to fuse. This fusing makes the spine less flexible and can result in a hunched-forward posture. Psoriasis is a long-lasting autoimmune disease characterized by patches of abnormal skin. Crohn's disease is an inflammatory bowel disease (IBD). It causes inflammation of your digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition.
The Brazilian Societies of Rheumatology (SBR) and Dermatology (SBD), the Brazilian Federation of Gastroenterology (FBG) and the Brazilian Study Group on Inflammatory Bowel Disease (GEDIIB) gathered a group of their respective specialists on the topic of interest to discuss the most relevant issues regarding the clinical use of biosimilar medicines in Brazil. The main aim of that meeting was to prepare a document with recommendations to guide medical specialists and to help the national regulatory and policy-making agencies as concerns the authorization for marketing Biosimilars used in autoimmune diseases, such as rheumatoid arthritis, Ankylosing spondylitis, psoriatic arthritis, Crohn's disease, juvenile idiopathic arthritis and ulcerative colitis. In addition to considerations on the typical differences between innovator medicines and Biosimilars, the specialists established a set of seven recommendations on regulatory advances related to clinical studies, indication extrapolation, nomenclature, interchangeability, automatic substitution and Pharmacovigilance.
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Editorial Manager
Research and Reports in Gastroentrology
Email: gastro@clinicalmedicaljournals.com