Access to generic lenalidomide (e.g. Revlimid) in Europe
February 28, 2022
Sandoz, a manufacturer of generic medicines, announced the launch of generic lenalidomide in 19 European countries. You can see the full press statement here.
Alternatively known under the branded name “Revlimid”, lenalidomide is a drug licensed and commonly used in the treatment of myeloma – in newly diagnosed, maintenance and relapsed settings.
Lenalidomide was first approved by the European Medicines Agency (EMA) in 2008 and has been solely marketed in Europe by Celgene / BMS until now. European rules incentivising pharmaceutical companies to develop medicines for orphan diseases like myeloma, provide companies with a patent covering ten years marketing exclusivity once they receive marketing authorisation (i.e. a license) from the EU. The patent expiry on Revlimid means that other companies can now manufacture, market and sell generic lenalidomide in the EU.
In some parts of Central and Eastern Europe, such as the Balkans, generic lenalidomide has already been available for a few years although MPE data shows access is variable.
Kate Morgan, Head of Policy and Access commented: “We very much welcome this announcement on generic lenalidomide. We are very hopeful that the availability of generic drugs will significantly reduce some costs associated with the myeloma pathway and increase access to medicines that prolong patient survival and improve quality of life. At MPE we will work hard to understand the impact of generic lenalidomide and other generic products on myeloma treatment access and continue to explore access challenges in countries where even generic medicines are unaffordable.”
MPE will be engaging with Sandoz in the coming weeks to understand which 19 countries are covered by their announcement and to discuss the questions we have relating to access. In addition to Sandoz, there are also likely to be other companies that will market generic lenalidomide, which MPE will be following and engaging with.
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