Camila Martino Parise

cpariseDpn.com br +55 (11) 3247-8499 www.pinheironeto.com.br

Angela Fan Chi Kung

akung@pn.com.br +55 (11) 3247-8622 www.pinheironeto.com.br

EXPERT GUIDE:810TECHNOLOGY & PHARMACEUTICALS 2017 BRAZ1 CorporateLiveWire

Sérgio Pinheiro Marçal

smarcal@pn.com.br +55 (11) 3247-8577 www.pinheironeto.comár

During the last decades, the development of pharmaceuticals obtained through biologi-cal fluids or animal tissues or via biotech pro-cedures has gained momentum and enabled the industry to offer therapeutic alternatives for several complex diseases for which there was no treatment until recently. These phar-maceuticals are costly, though, and widely in-accessible for the general public - which trans-lates into a challenge for every government across the world to find ways to incorporate those pharmaceuticals unto their public health-care policies. Within this context, biosimilars are seen as an affordable means to expand the access to biopharmaceuticals.

In Brazil, biological medicai products are regulated by the National Public Health Agency - ANVISAI and fall into two dif-ferent categories: (i) "new biological prod-uct", i.e. product containing a molecule with known biological activity as yet unregistered in Brazil but which has passed through ali manufacturing steps (formulation, filling, ly-ophilization, 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 bi-ological activity already registered in Brazil and

which has passed through ali the manufactur-ing 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 'biosimi-lars', given the greater complexity of biological products vis-à-vis synthetic and semi- synthetic drugs, and also considering the impossibil-ity of duplication in their production process. The existence of generic biopharmaceuticals was also ruled out under Brazilian iaw, mostly because of the non-applicability of bioequiva-lence. Consequently, in Brazil, biological medi-cal products containing a molecule already reg-istered in Brazil are merely referred to as "bio-logical products".

Biologicais may only be marketed in Brazil af-ter the quality, efficacy and safety conditions are approval by ANVISA.

For new biological products, the applicant must present to ANVISA a complete techni-cal and scientific registration dossier. Biologi-cal products, in turn, are registrable based on two path ways: (1) individual development, in which case the applicant must provide

ANVISA with a complete technical and scien-tific registration dossier including clinicai and non-clinical data; ar (ii) comparability, in which case the product is registered upon compari-son of its efficacy and safety attributes with a comparator product, which is a product al-ready registered at ANVISA. Also, the reg-istration process of biological products un-der the comparability path way must follow the guidelines approved by ANVISA and, currently, ANVISA has approved the guide-lines for the registration of the alphainterferon and heparin.

Biological products registered through compa-rability channels equate to biosimilar products. Biological products registered via individual development, in turn, are non-biosimilar alter-

natives since they have not gone through the comparability test.

For both registrations path ways, in case of im-ported products, the biological product must have been registered in the country of manu-facturing for further approved by ANVISA.

Once registered with ANVISA, a biological product can only be put up for safe in the do-mestic market after its price is stipulated by the Medication Chamber (CMED), based on preset criteria; for a biological product with proven therapeutic gains, for instante, the safes 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 safes price will then depend on whether the

PINHEIRONETO ADVOGADOS

Biosimilars in Brazil By Sérgio Pinheiro Marçal, Angela Fan Chi Kung & Camila Martino Parise

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EXPERT GUIDE:810TECHNOLOGY & PHARMACEUTICALS 2017 BRAZ1 CorporateLiveWire

&& 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.

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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 Gov-ernment has been investing in the development of "biological products" in Brazil by conduct-ing 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 part-ner has exclusive rights to supply the product to the government,

With the PDPs the government aims to have access to priority technologies, reduce the vul-nerability 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® (in-fliximab) and Fiprima (filgrastim), the lat-ter having been fully developed in Brazil. Registrations are expected to soar in the up-

coming years, but those two products are yet to be launched in the Brazilian market after their sales prices are defined by CMED. (Endnotes)

1 Resolution RDC No. 55/2010 and Resolutton RDC No. 49/2011 issued by the National Public Health Agency - ANVISA.

Mrs. Parise is a Brazilian attorney who prac-tices in the regulatory area with emphasis in life sciences, and counsel of Pinheiro Neto Ad-vogados, where she lias worked since 1998. She has a LL.B. degree from the Universidade Pau-lista - UNIP (2000) and Specialisation degree in Public Law from the Getúlio Vargas Founda-tion (2006). Member of the Sanitary Law Com-mittee of the Brazilian Bar Association (São Paulo). Mrs. Parise has written severa! articles on life sciences in domestic and international publications and lias participated as a speak-er in various seminars related to health area.

Mrs. Parise was recognised in the fields of Life Sciences by Who is Who Legal and Chambers dr Partners. Sérgio Pinheiro Marçal is a Bachelor of law from the Paulista College of Law at Pontífice

Catholic University (Faculdade Paulista de Di-reito da Pontifícia Universidade Católica - PUC); credits toward a Master's degree at PUC. Lan-guages: Portuguese and English.

Partner in the Litigation Department at the law firm Pinheiro Neto Advogados since 1996. Arcas of expertise: Class actions, consumer law, product liability, civil litigation, and life sciences. He is a former Chairman of the São Paulo Law-yers Association (AASP).

His narre is highly recommended as a product liability law practitioner by Chambers and Part-ners, Who's Who Legal, Best Lawyers and Euro-money World Leading Lawyers. He has also been repeatedly named a most admired attorney in consumer and product liability practice by Bra-zilian magazine Análise Advocacia.

Angela Pan Chi Kung's Education: LL.B. degree from the São Paulo University -

1993 LL.M. degree from the Georgetown Univer-sity, Washington DC, USA - 1999 LL.B. Specialist in Sanitary Law from the São Paulo University, Public Health School Interna-tional experiente

Other Work Experiente: Foreign associate at HogandrHartson (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 In-dustry at the MBA of FGV and at Instituto Sírio Libanês de Ensino e Pesquisa; and of Le-gal aspects of clinicai 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 Law-yer?

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