November 1 ,2013 | By Márcio Barra
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.
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Biosimilar drugs in Portugal
Marketing authorization holder
|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|