Commentary piece published on Biosimilar drugs in HemaSphere journal by Chair of PNH Support
The Chair of PNH Support, Maria Piggin has authored a commentary piece in the April 2022 edition of he scientific journal HemaSphere entitled “Addressing Inequality of Access to Biologics: What Is Your Role? A Patient (Advocate)’s Perspective on Biosimilars.” In this piece, Maria describes (from her experience) the lack of education of both healthcare professionals and patients about biosimilar drugs and the role each can play in the licensing and use of these drugs for treating patients.
The European Medicines Agency (EMA) describes biosimilars as “a biological medicine highly similar to another biological medicine already approved in the EU (called ‘reference medicine’) in terms of structure, biological activity and efficacy, safety and immunogenicity profile (the intrinsic ability of proteins and other biological medicines to cause an immune response)”.
With approximately 75% of countries around the world having no access to treatments for Paroxysmal Nocturnal Haemoglobinuria (PNH) due to their cost, biosimilars offer a possibility for treating patients should their price be less than reference products. The patent for eculizumab (one of the licensed reference products for treating those with PNH) ends in 2025 meaning a biosimilar for this biologic product could be an option for treating patients in future (especially and importantly those who currently have no access to treatment). A biosimilar for eculizumab (called Elizaria) has also been licensed in Russia since 2019.
The EMA has produced a Question and Answer document for patients about biosimilars here.