Biological and nonbiological complex drugs for multiple sclerosis in Latin America: regulations and risk management

Abstract

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.

Keywords:

• biosimilars
• glatiramer acetate
• interferon
• monoclonal antibodies
• multiple sclerosis

Financial & competing interests disclosure

The meeting was facilitated by an unrestricted educational grant from TEVA Pharmaceutics. All authors have received support for attending conferences, received honoraria for talks and may act in Advisory Boards for the following; Biogen Idec, Merck-Serono, Sanofi, Genzyme, Bayer Schering, and TEVA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Biological drugs and nonbiological complex drugs are extensively used for the treatment of multiple sclerosis.

• Approval of a biosimilar drug by a regulatory agency implies extensive testing on quality, safety and efficacy.

• Therapeutic equivalence and interchangeability are crucial issues for approving a biosimilar or a complex molecule follow-on drug.

• Specific pharmacovigilance programs must be implemented and encouraged to be used for reports on biosimilars and nonbiological complex follow-on drugs.

• Commercial interests cannot prevail over efficacy and safety of medications.

• Biosimilars and complex molecule follow-on drugs of good quality and low price will have a place for multiple sclerosis therapy.