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Regulatory pathways for approval of biological products in Brazil

Up until 2002, Brazil had no specific guidance for biological products. In 2002 guidelines for biological products were published (RDC 80/2002), which had to be followed by both originator biologicals and ‘follow-on biological products’.

Regulation of follow-on biological products in Brazil

The regulatory body for approval of medicines in Brazil is the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) [1]. The agency was created by Law 9782, which was enacted in 1999 [2]. Since then, numerous guidance for biologicals and follow-on biological products have been issued by ANVISA, see Figure 1.

Producing follow-on biological products in Brazil

Retail pharmaceutical sales in Brazil have an average annual growth rate of 12.48% and have increased from US$7.9 billion in 2005 to US$28.02 billion in 2014. In 2008, Brazil was rated as the 10th largest market for pharmaceuticals, but by 2013 the country was ranked at No. 6 and by 2018 it is expected to reach No. 4 in the world [1].

Building trust in biosimilars

How to build trust in biosimilars was a subject highlighted at the Biosimilar Medicines Group’s (EBG) satellite symposium at the 2017 European Association of Hospital Pharmacists conference [1].

FDA looks set to break record for generic drug applications

So far in 2017 the US Food and Drug Administration (FDA) has approved over 630 generic drug applications, and looks set to overtake last year’s record total of 651 approvals.

Interchangeability of biosimilars in the US

The US Food and Drug Administration (FDA) has different requirements for biosimilars depending on whether they are defined as ‘biosimilar’ or ‘interchangeable’ [1].

Interchangeability of biosimilars around the world

There is a lack of harmonization around the world when it comes to how different countries or regions approach interchangeability of biosimilars [1].

Biosimilar substitution in Europe

In the European Union (EU), decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by the European Medicines Agency (EMA), but at the national level. This is despite the fact that biosimilars developed in line with EU requirements are considered by EMA to be therapeutic alternatives to their reference biologicals.

Product-specific pharmacovigilance

Four key considerations for biosimilar interchangeability have been proposed by Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen. He also outlined five principles to address these considerations. The fifth of these principles addresses product-specific pharmacovigilance [1].

Sound pharmacy practices for biosimilars

To address the four key considerations for biosimilar interchangeability Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen outlined five principles during his presentation at the SMi 3rd Annual Biosimilars USA Conference [1]. The fourth of these principles is that there should be sound pharmacy practices for biosimilars.

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