Biological and nonbiological complex drugs for multiple sclerosis in Latin America: regulations and risk management.
Biological drugs and nonbiological complex drugs with expired patents are followed by biosimilars and follow-on drugs that are supposedly similar and comparable with the reference product in terms of quality, safety and efficacy. Unlike simple molecules that can be copied and reproduced, biosimilars and follow-on complex drugs are heterogeneous and need specific regulations from health and pharmacovigilance agencies. A panel of 14 Latin American experts on multiple sclerosis from nine different countries met to discuss the recommendations regarding biosimilars and follow-on complex drugs for treating multiple sclerosis. Specific measures relating to manufacturing, therapeutic equivalence assessment and pharmacovigilance reports need to be implemented before commercialization. Physical, chemical, biological and immunogenic characterizations of the new product need to be available before clinical trials start. The new product must maintain the same immunogenicity as the original. Automatic substitution of biological and complex drugs poses unacceptable risks to the patient.
Hospital Británico, Buenos Aires, Buenos Aires, Argentina.
Adriana
A
Carrá
Miguel Angel
MA
Macías Islas
Adriana
A
Tarulla
Denis Bernardi
DB
Bichuetti
Alessandro
A
Finkelsztejn
Yara Dadalti
YD
Fragoso
Raul
R
Árcega-Revilla
Claudia
C
Cárcamo Rodríguez
Juan Carlos
JC
Durán
Juan García
JG
Bonitto
Rosalba
R
León
Carlos
C
Oehninger Gatti
Geraldine
G
Orozco
Darwin
D
Vizcarra Escobar
D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D004335:Drug and Narcotic Control; D005104:Expert Testimony; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007843:Latin America / Q000453:epidemiology; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000453:epidemiology; D012308:Risk Management
D059451:Biosimilar Pharmaceuticals; D007155:Immunologic Factors
biosimilars; glatiramer acetate; interferon; monoclonal antibodies; multiple sclerosis