Biosimilar drugs in Portugal

November 1 ,2013 | By Márcio Barra

Remsima, one of the Biosimilars of a Monoclonal Antibody approved by the EMA

What follows is a list of Biosimilar drugs available in Portugal. This data has been compiled from the INFOMED database, managed by the Portuguese National Competent Authrority on Medicines, INFARMED.  The Portuguese Marketing approval date was also provided. In the Market Status, you may find “no data” on some drugs. This means that the drug in question has no information displayed on the INFOMED database, save for its name.

Biosimilars are, for the sake of clarity, essentially generic versions of biologic drugs – drugs where the active substance is a large molecule, usually a protein, obtained from an organism. Unlike generics, biosimilars are not exact copies of the original molecule, since the manufacturing process usually differs between the two, leading to the creation of a similar, but not exactly alike, molecule. For a biosimilar to be approved by EMA and the EC, it has to show similarity and lack of significant differences in terms of quality, efficacy and safety compared to the reference biologic medicine.

The first biosimilar ever approved in Europe dates back to 2006, when Omnitrope (somatropin) was approved. Since then, a total of 12 biosimilar products were authorized. Two of the latest biosimilars to be approved were Remsima and Inflectra, the first monoclonal antibody biosimilars of the molecule Infliximab. Twelve biological products with global sales of more than US$67 billion will be exposed to biosimilar competition by 2020, making the Biosimilar market a highly attractive, if very difficult to tackle, market.

Currently, there are 6 biosimilars available for sale in Portugal – Binocrit and Zarzio, from Sandoz GmbH, Retacrit, Nivestim and Inflectra, from Hospira UK Limited, and Tevagrastim, from Teva.

If you want to have the table in a .PDF format, send an e-mail to marciobarra@ua.pt and we will send you.

Biosimilar drugs in Portugal

Active Substance

Brand Name

Marketing authorization holder

Commercialization

Pharmaceutical form

Epoetin Alfa Abseamed Medice Arzneimittel Pütter GmbH & Co. KG Not sold Injectable solution
Epoetin Alfa Binocrit Sandoz GmbH Sold since 07/10/2010 Injectable solution
Epoetin Alfa Epoetin alfa Hexal Hexal A.G. Not sold Injectable solution
Epoetin Zeta Retacrit Hospira UK Limited Sold since 01/01/2009 (Syringe – 6 units- 0.3 ml).Sold since 14/04/2008 (Syringe – 6 units – 1 ml) Injectable solution
Epoetin Zeta Silapo Stada Arzneimittel A.G. Not sold Injectable solution
Filgrastim Biograstim CT Arzneimittel GmbH No data Injectable solution
Filgrastim Filgrastim Hexal Hexal A.G. No data Injectable solution
Filgrastim Nivestim Hospira UK Limited Sold since 01/07/2010 Injectable solution or perfusion
Filgrastim Ratiograstim Ratiopharm GmbH Not sold Injectable solution or perfusion
Filgrastim Tevagrastim Teva Generics GmbH Sold since 15/01/2010 (Syringe – 5 units) – 0.5 m and 0.8 ml) Injectable solution or perfusion
Filgrastim Zarzio Sandoz GmbH Sold since 30/11/2012 (Syringe – 1 unit – 0.5 ml) and Sold since 09/11/2012 (Syringe- 5 units – 0.5 ml) and sold since 24/07/2012 (Syringe – 1 unit – 0.5 m) and sold since 13/09/2012 (Syringe – 5 unita – 0.5 ml) Injectable solution or perfusion
Folitropin alfa Ovaleap Teva Pharma, B.V. No data (EMA’s approval was on 27/09/2013) Injectable solution
Infliximab Inflectra Hospira UK Limited Sold since 15/10/2013 Powder for concentrate for solution for infusion
Infliximab Remsima Celltrion Healthcare Hungary Kft. Not sold (approved by EMA on 10/09/2013) Powder for concentrate for solution for infusion
Somatropine Omnitrope Sandoz GmbH Not sold Powder and solvent for solution for injection

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