Brazil to remove backlog for generics

Generics/General | Posted 09/11/2018 post-comment0 Post your comment

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.

Brazil flag V13C03

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: ANVISA, RAPS

comment icon Comments (0)
Post your comment
Related content
Generic drug growth in Brazil and Venezuela
53 MD002445
Generics/General Posted 15/09/2023
Pharmaceutical manufacturing companies in Brazil
91 AA007225
Generics/General Posted 26/08/2022
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010