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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.

Safe switching for biosimilars

Five principles to address the four key considerations for biosimilar interchangeability were presented by Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen at an annual biosimilars conference [1]. The third of these principles is that clinically relevant evidence of safe switching for biosimilars is required.

Drug pricing to remain a challenge for the industry

Pricing is the foremost issue facing the pharmaceutical industry, and is especially prominent in the US. Pharmaceutical companies are renowned for charging more for their drugs in the US than in other Western nations, sometimes by up to five times. 

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