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Brazil to remove backlog for generics Posted 09/11/2018

Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) announced on 3 October 2018 that it will eliminate a backlog of new and generic drug applications by January 2019.

Raphael Sanches Pereira, General Manager at ANVISA said that more than 800 new and generic drug applications were backlogged as of January 2017 but that the agency planned to have reduced this to zero by January 2019.

ANVISA has also announced that it would end the delays in starting reviews of generics by the end of August 2018. The agency said that between April 2017 and May 2018 it had analysed 744 applications. However, at the moment there were just over 30 requests awaiting the start of the registration analysis.

The reduction in analysis time has been made possible through a series of internal improvement strategies in the work process, which allowed the agency to speed up the analysis. This process was triggered by the implementation of Strategic Project #1, leveraged by Law 13.411, of December 2016, which provides for the improvement of the evaluation of the requests of companies regarding new registrations and post registrations.

The elimination of registration and approval backlogs will allow ANVISA to focus on new projects, according to Sanches Pereira. The agency is hoping to change the rules for registration of active pharmaceutical ingredients (APIs) to simplify the registration of drugs. To do this, ANVISA is proposing a reliance on the Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) granted by the European Directorate for the Quality of Medicines and HealthCare (EDQM). This would bring Brazil in line with other countries such as Albania, Algeria, Australia and Canada which all currently accept CEPs.

With respect to biologicals, Brazil is working on a system where it would partly rely on decisions made by other regulatory agencies, based on risk-based criteria.

Brazil introduced guidelines for follow-on biological products in December 2010 [1]. Since then at least three follow-on biological products have been approved in the country [2]. In April 2015, Remsima (infliximab) produced by Celltrion was approved [3]. This was followed by approval of Fiprima (filgrastim) from Eurofarma Laboratórios in October 2015 [4]. In December 2017, Biocon and Mylan’s trastuzumab follow-on biological Zedora was approved by ANVISA through their Brazilian partner Libbs Farmaceutica (Libbs) [5].

Related article
Producing follow-on biological products in Brazil

References
1. GaBI Online - Generics and Biosimilars Initiative. Brazilian guidelines for follow-on biological products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Guidelines/Brazilian-guidelines-for-follow-on-biological-products
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 Nov 9]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America
3. GaBI Online - Generics and Biosimilars Initiative. Brazil approves first monoclonal antibody follow-on biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/News/Brazil-approves-first-monoclonal-antibody-follow-on-biological
4. GaBI Online - Generics and Biosimilars Initiative. Filgrastim follow-on biological approved in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/News/Filgrastim-follow-on-biological-approved-in-Brazil
5. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilars receive EMA and ANVISA approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilars-receive-EMA-and-ANVISA-approval

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Source: ANVISA, RAPS

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