The Brazilian Society of Clinical Oncology (SBOC) has issued a position statement on ‘follow-on biological products’ in oncology. The statement reflects the society’s views on issues such as naming, labelling, safety and efficacy, extrapolation of indications, interchangeability, switching and substitution of ‘follow-on biological products’, as well as on the potential impact ‘follow-on biological products’ may have on the financial burden in health care [1].
SBOC makes the following recommendations.
Extrapolation: SBOC believes that extrapolation for each proposed indication should ideally be supported by scientific evidence from a randomized phase III clinical trial. The society adds that extrapolation should be made on a case-by-case basis, because current scientific evidence is not sufficient to automatically support extrapolation between the reference drug and its ‘follow-on biological products’.
Interchangeability: SBOC acknowledges that there are currently no clinical studies supporting the interchangeability of any ‘follow-on biological products’ approved in Brazil with their respective reference products. It adds that patients, as much as possible, should remain on the same biological throughout treatment. Where this is not possible SBOC recommends that interchangeability should only occur under strict conditions, including the approval of the attending physician and without interference from the pharmacist.
Naming: SBOC says it is important to adopt a naming system that provides an ‘identifier’ to be used for all ‘follow-on biological products’, enabling pharmacovigilance at all times. Thus, it is essential that the physician be specific when prescribing biologicals.
Pharmacovigilance: SBOC recognizes the key role played by pharmacovigilance and says it is important to implement a tracking system for biologicals and ‘follow-on biological products’. In addition, SBOC recognizes that current pharmacovigilance programlmes in Brazil are insufficient and is of the opinion that cancer treatment centres across the country should adopt more stringent pharmacovigilance practices.
Clinical trials: SBOC understands that clinical evidence should be provided for the approval of ‘follow-on biological’ oncology drugs. SBOC follows World Health Organization (WHO) recommendations that equivalence studies are preferred.
Education: SBOC recognizes the urgent need to implement training on ‘follow-on biological products’ and pharmacovigilance and suggests that ‘follow-on biological product’ developers should play an active role in facilitating pharmacovigilance efforts.
Public health is a constitutional right in Brazil. This fact makes the Brazilian Government the largest buyer of biologicals in the country, accounting for 60% of all purchases, and raising interest among national industries for the production of biologicals or ‘follow-on biological products’. Currently, two national pharmaceutical consortia – Bionovis and Orygen – encompassing a range of national laboratories are involved in the development of ‘follow-on biological products’.
Although, the pharmaceutical industry in Brazil still lacks the technology for the production of ‘follow-on biological’ oncology drugs, public laboratories, such as Bio-Manguinhos of the Oswaldo Cruz Institute (IOC), have signed technology transfer agreements and produced infliximab and interferon-gamma. There is also increasing interest from private industry.
To date, only two ‘follow-on biological products’ have been approved in Brazil: Fiprima (filgrastim) and Remsima (infliximab) [2]. However, the number of ‘follow-on biological product’ applications filed with Brazil’s drug regulatory agency ANVISA (Agência Nacional de Vigilância Sanitária) is expected to grow in the coming years.
SBOC says that it is ‘in favour of the introduction of biosimilars, as they offer a viable, safe and cost-effective alternative to the biopharmaceutical products currently used in cancer’.
Conflict of interest
The authors of the research paper [1] did not provide any conflict of interest statement.
Related articles
ASCO issues position statement on biosimilars in oncology
Brazilian guidelines for follow-on biological products
References
1. Fernandes GS, Sternberg C, Lopes G, Chammas R, Gifoni MAC, Gil RA, Araujo DV. The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC). Braz J Med Biol Res. 2018;51(3):e7214.
2. GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 18]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America
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