Brazil's Anvisa publishes two biologics guidelines for reporting clinical trial results and obtaining production registration

Brazil's health surveillance agency Anvisa has published two biologics guidelines to harmonise the legal regulation of some aspects of biologics clinical research and production. The first outlines the way to report outcomes of clinical trials in biological oncology treatments. The second one details the way to report the validation process to produce biologics.

Clinical trial outcomes

Specifically, this guideline aims to communicate to the pharmaceutical industry Anvisa's expectations regarding the presentation of clinical trial results, in order to achieve registration of biological oncology treatments. This guideline is valid from 9 October and can be accessed here, in Portuguese.

This guideline applies to the treatment of patients with cancer, and not including treatments to prevent or reduce the incidence of cancer. According to Anvisa's guideline, clinical studies on safety and effectiveness are required for the registration of new synthetic drugs and biological cancer products, which must be transported, submitted and evaluated on a harmonised basis and with all scientific rigour. Parameters related to the disease, such as gravity, rarity, prevalence, and potential risk to life must be addressed in order to decide the primary and secondary endpoints of efficacy.

Validation production process

To establish a high standard of quality in the production of medicines, the validation of the production process in the pharmaceutical industry is a way of ensuring the provision of constant and consistent medicines that meet safety and quality standards. Anvisa's guide identifies the steps and the critical parameters of the production process (such as those affecting the product quality) that should be included in the production process of biologics, and other relevant studies which demonstrate that the process is able to produce safe and high-quality medical treatments.

Anvisa's new guideline on this matter is valid from 9 October and can be accessed here, in Portuguese.

Outlook and implications

These two guidelines are part of a group of recent guidelines published by the health agency in order to better enable the industry to fulfill national standards in the research, commercialisation, production, and distribution of biologic medicines (see Brazil: 19 October 2015: Brazil's Anvisa publishes biologics guidelines).

The guidelines have been enforced since the day of publication (9 October) but are subject to the receipt of contributions until April 2016. These guidelines are not binding; every pharmaceutical company should assess the guides' content and applicability.

With the presence of more biologics originators and biosimilars in the Brazilian market, Anvisa has tried to strengthen the regulations and non-binding instruments of biologic medicines in order to guarantee the quality and safety of these medicines.

In Brazil, approval of biosimilars, which are officially known as "biologic products", can follow two pathways: the individual and the comparative. The comparative pathway follows international standards incorporated in the World Health Organization (WHO)'s guidelines on similar biotherapeutic products, whereas the individual pathway was introduced with the aim of opening up the opportunity to small producers (potentially domestic producers) to achieve approval of less complex biosimilars. In April, Anvisa approved the first biosimilar under the comparability route (see Brazil: 28 April 2015: Brazil's Anvisa approves biosimilar Remsima under comparability pathway).