With our enoxaparin biosimilar, we hope to increase our presence in Europe, the United States and emerging countries.
- ROVI’s history has been linked to heparins since the company began. Therefore, this enoxaparin biosimilar is a logical evolution within our activity. ROVI has successfully completed the decentralized procedure to apply for marketing authorization for a low-molecular-weight heparin (enoxaparin biosimilar) in twenty-six European Union countries.
- We have commenced the national phases of the registration process of our enoxaparin biosimilar.
- By 31st March 2018, the countries with the national registration approved of the enoxaparin biosimilar are Germany, France, United Kingdom, Italy, Norway, Sweden, Austria, Hungary, Slovenia, Estonia, Latvia, Slovakia, Bulgaria, Romania, Spain and Croatia.
- In 2017, we started our internationalization process, setting up subsidiaries in the main European countries: Germany, United Kingdom, France and Italy.
- Likewise, we began the marketing of the enoxaparin biosimilar in Germany and UK, two top enoxaparin countries in Europe.
- ROVI has obtained approval for two registrations in Europe. Depending on the evolution of the market, we may use one of these registration to grant licenses to third parties.
- We have now concluded distribution agreements with local and/or international partners, subject to obtaining marketing authorization from the national authorities of the respective countries, in order to market the product in 26 countries outside the European Union and United States.
- In the United States, our negotiations with a partner for distribution of our enoxaparin biosimilar are at an advanced stage.
- ROVI will manufacture and package its enoxaparin biosimilar in Spain. In the last three years, ROVI has invested 17.2 million euros in its plants, in order to increase the capacity and prepare for this new production milestone.
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