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 Disease--Focus on clinical evaluation of monoclonal antibodies and fusion proteins used in the treatment of autoimmune diseases.
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.
Brazilian Society of Rheumatology, Brazil. Electronic address: valderilio@hotmail.com.
Valderílio Feijó
VF
Azevedo
Brazilian Society of Rheumatology, Brazil.
Eduardo de Souza
Ede S
Meirelles
Brazilian Society of Rheumatology, Brazil.
Jussara de Almeida Lima
Jde A
Kochen
Brazilian Society of Rheumatology, Brazil.
Ana Cristina
AC
Medeiros
Brazilian Federation of Gastroenterology, Brazil; Brazilian Study Group on Inflammatory Bowel Disease, Brazil.
Sender J
SJ
Miszputen
Brazilian Study Group on Inflammatory Bowel Disease, Brazil.
Fábio Vieira
FV
Teixeira
Brazilian Study Group on Inflammatory Bowel Disease, Brazil.
Adérson Osmar Mourão Cintra
AO
Damião
Brazilian Study Group on Inflammatory Bowel Disease, Brazil.
Paulo Gustavo
PG
Kotze
Brazilian Society of Dermatology, Brazil.
Ricardo
R
Romiti
Brazilian Society of Dermatology, Brazil.
Marcelo
M
Arnone
Brazilian Society of Dermatology, Brazil.
Renata Ferreira
RF
Magalhães
Brazilian Society of Dermatology, Brazil.
Cláudia Pires Amaral
CP
Maia
Brazilian Society of Dermatology, Brazil.
André Vicente E
AV
de Carvalho
D000818:Animals; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001327:Autoimmune Diseases / Q000188:drug therapy*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D001938:Brazil; D005767:Gastrointestinal Diseases / Q000188:drug therapy; D006801:Humans; D011994:Recombinant Proteins / Q000627:therapeutic use*; D012955:Societies, Medical
D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins
Ankylosing spondylitis; Autoimmune diseases; Biosimilars; Crohn's disease; Psoriasis; Rheumatoid arthritis