Overview of research on regulatory issues surrounding biosimilars in 2012

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Overview of research on regulatory issues surrounding biosimilars in 2012

Biosimilars/Research | Posted 07/12/2012 0 Post your comment

Period: January to August 2012

In the area of regulation of biosimilars Europe has by far the best-established framework for approval and EMA has already issued both general and product specific guidelines for biosimilar applications to the EU [1]. The first biosimilar was approved in the EU in 2006 for Omnitrope (somatropin). There are now 14 biosimilars approved for use in Europe for three reference products: erythropoietin, granulocyte-colony stimulating factor and somatropin [2].

The US is somewhat behind, but has issued draft guidance and is expected to have a practical pathway in place in the near future.

Other countries, such as Canada and Japan, as well as WHO, have also established biosimilars guidelines based on the principles of the EU Framework.

This article discusses some of the research papers on the regulatory issues surrounding biosimilars that have been published during the period of January to August 2012. Topics investigated by researchers included whether applicants with similar products followed a full or abbreviated application procedure and issues facing biosimilar low molecular weight heparins (LMWH).

Abridged or full application
In the EU, the regulatory policy for biosimilars has enabled these products to be marketed via an abridged application–which allows the applicant to submit a reduced dossier. Nevertheless, some manufacturers of biological products that share some characteristics with copies have opted for a full application; requiring an increased number and more extensive clinical studies.

In a study by Minghetti et al. the authors analyse and discuss clinical studies submitted to EMA, with a focus on a comparison of recombinant human erythropoietin medicinal products, that relate to available biosimilars and biological medicinal products that are authorized with a full dossier. The issue of interchangeability and substitution is also discussed, given that the EU allows each Member State to set their own substitution policies [3].

Low molecular weight heparins
In the US copies of LMWH have been approved via a generics application procedure. While EMA’s biosimilars guideline mandates clinical trials for LMWHs, FDA approved Momenta’s M-Enoxaparin based solely on analytical data. Approval via the generics pathway also means that Momenta’s product is directly interchangeable or substitutable with the originator, which is not the case in Europe, where each country makes its own decision on interchangeability.

Authors García-Arieta et al. discuss the regulatory considerations for generic or biosimilar LMWHs taking into account the differences between FDA and EMA with respect to demonstration of chemical/biological, non-clinical and clinical requirements in these two regulatory authorities [4].

The research highlights the importance of having clear pathways in place for biosimilars as well as whether reduced or full applications have the advantage and shows some of the differences between Europe and the US when it comes to biosimilars.

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References

1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Dec 7]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars

2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Dec 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

3. Minghetti P, Rocco P, Cilurzo F, Vecchio LD, Locatelli F. The regulatory framework of biosimilars in the European Union. Drug Discov Today. 2012;17(1-2):63-70.

4. García-Arieta A, Blázquez A. Regulatory considerations for generic or biosimilar low molecular weight heparins. Curr Drug Discov Technol. 2012;9(2):137-42.

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