Biosimilars in Brazil
By Sérgio Pinheiro Marçal, Angela Fan Chi Kung & Camila Martino Parise
Posted: 9th August 2017 09:24During the last decades, the development of pharmaceuticals obtained through biological fluids or animal tissues or via biotech procedures has gained momentum and enabled the industry to offer therapeutic alternatives for several complex diseases for which there was no treatment until recently. These pharmaceuticals are costly, though, and widely inaccessible for the general public – which translates into a challenge for every government across the world to find ways to incorporate those pharmaceuticals into their public healthcare policies. Within this context, biosimilars are seen as an affordable means to expand the access to biopharmaceuticals.
In Brazil, biological medical products are regulated by the National Public Health Agency – ANVISA and fall into two different categories: (i) “new biological product”, i.e. product containing a molecule with known biological activity as yet unregistered in Brazil but which has passed through all manufacturing steps (formulation, filling, lyophilization, labelling, packaging, storage, quality control, and release of the new product batch for use), and (ii) “biological product”, i.e. product containing a molecule with known biological activity already registered in Brazil and which has passed through all the manufacturing steps (formulation, filling, lyophilization, labelling, packaging, storage, quality control, and release of the product batch for use).
Unlike the USA and Europe, the Brazilian laws have not embraced the expression ‘biosimilars’, given the greater complexity of biological products vis-à-vis synthetic and semi-synthetic drugs, and also considering the impossibility of duplication in their production process. The existence of generic biopharmaceuticals was also ruled out under Brazilian law, mostly because of the non-applicability of bioequivalence. Consequently, in Brazil, biological medical products containing a molecule already registered in Brazil are merely referred to as “biological products”.
Biologicals may only be marketed in Brazil after the quality, efficacy and safety conditions are approval by ANVISA.
For new biological products, the applicant must present to ANVISA a complete technical and scientific registration dossier. Biological products, in turn, are registrable based on two path ways: (i) individual development, in which case the applicant must provide ANVISA with a complete technical and scientific registration dossier including clinical and non-clinical data; or (ii) comparability, in which case the product is registered upon comparison of its efficacy and safety attributes with a comparator product, which is a product already registered at ANVISA. Also, the registration process of biological products under the comparability path way must follow the guidelines approved by ANVISA and, currently, ANVISA has approved the guidelines for the registration of the alphainterferon and heparin.
Biological products registered through comparability channels equate to biosimilar products. Biological products registered via individual development, in turn, are non-biosimilar alternatives since they have not gone through the comparability test.
For both registrations path ways, in case of imported products, the biological product must have been registered in the country of manufacturing for further approved by ANVISA.
Once registered with ANVISA, a biological product can only be put up for sale in the domestic market after its price is stipulated by the Medication Chamber (CMED), based on preset criteria; for a biological product with proven therapeutic gains, for instance, the sales price cannot be higher than its price list effective in a basket of countries selected by CMED (when there are no manifest therapeutic gains, the sales price will then depend on whether the product in new on the list of those traded by the company).
Because of the financial impact that this type of product poses to public savings, Brazilian Government has been investing in the development of “biological products” in Brazil by conducting Partnership for Productive Development (PDP) with private companies.
The PDPs arrangement involves the transfer of technology by private companies to a P&D’s public institution and, in return, during the transfer of technology period, the private partner has exclusive rights to supply the product to the government.
With the PDPs the government aims to have access to priority technologies, reduce the vulnerability of the Unified Health System (SUS) and long-term rationalization and reduction of prices of strategic products for health.
To date, ANVISA has granted registration for two biological products, Remsima® (infliximab) and Fiprima® (filgrastim), the latter having been fully developed in Brazil. Registrations are expected to soar in the upcoming years, but those two products are yet to be launched in the Brazilian market after their sales prices are defined by CMED.
Camila Martino Parise
Phone: +55 (11) 3247-8499
Mrs. Parise is a Brazilian attorney who practices in the regulatory area with emphasis in life sciences, and counsel of Pinheiro Neto Advogados, where she has worked since 1998. She has a LL.B. degree from the Universidade Paulista – UNIP (2000) and Specialisation degree in Public Law from the Getúlio Vargas Foundation (2006). Member of the Sanitary Law Committee of the Brazilian Bar Association (São Paulo). Mrs. Parise has written several articles on life sciences in domestic and international publications and has participated as a speaker in various seminars related to health area. Mrs. Parise was recognised in the fields of Life Sciences by Who is Who Legal and Chambers & Partners.
Sérgio Pinheiro Marçal
Telefone: +55 (11) 3247-8577
Bachelor of law from the Paulista College of Law at Pontifice Catholic University (Faculdade Paulista de Direito da Pontifícia Universidade Católica - PUC); credits toward a Master’s degree at PUC.
Languages: Portuguese and English.
Partner in the Litigation Department at the law firm Pinheiro Neto Advogados since 1996.
Areas of expertise: Class actions, consumer law, product liability, civil litigation, and life sciences.
He is a former Chairman of the São Paulo Lawyers Association (AASP).
His name is highly recommended as a product liability law practitioner by Chambers and Partners, Who’s Who Legal, Best Lawyers and Euromoney World Leading Lawyers. He has also been repeatedly named a most admired attorney in consumer and product liability practice by Brazilian magazine Análise Advocacia.
Angela Fan Chi Kung
Life Sciences & IP
T: +55 (11) 3247-8622
LL.B. degree from the São Paulo University - 1993
LL.M. degree from the Georgetown University, Washington DC, USA – 1999
LL.B. Specialist in Sanitary Law from the São Paulo University, Public Health School International experience
Other Work Experience:
Foreign associate at Hogan&Hartson (Hogan Lovells), Washington DC, USA -1999
Member of the Sanitary Law Committee of the Brazilian Bar Association (São Paulo)
Member of Research Ethics Committee of UNIFESP – Universidade de Sao Paulo
Professor of Regulation of Pharmaceutical Industry at the MBA of FGV and at Instituto Sírio Libanês de Ensino e Pesquisa; and of Legal aspects of clinical trials at Santa Casa de Misericórdia
Recommended at Chambers Latin America (Band 1), Chambers Global (Band 1), Who’s Who Legal, Latin Lawyer 250, PLC Which Lawyer?
Resolution RDC No. 55/2010 and Resolution RDC No. 49/2011 issued by the National Public Health Agency – ANVISA.