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The EGA has been contacted by Genzyme regarding a new enzyme replacement therapy called ‘Abcertin’ manufactured in Korea, which is being marketed as a biosimilar.
Genzyme has asked the EGA and the EWGGD for support by sending the attached letter and has asked us to circulate it to all our members so that you can send it to all the doctors in your country that treat Gaucher patients.
Although Abcertin is being marketed as a biosimilar it has only been approved under an abbreviated approval process in Korea that gives a conditional approval to a drug based on limited data until more data is generated. Therefore this product does not meet the global definition of a biosimilar medicine based on ‘regulatory expectations and risk assessment for biotherapeutics’ or the ‘WHO issued guidelines on similar biotherapeutics products’.
Please share this letter with the doctors in your country to ensure that the correct information is available to all doctors and patients when prescribing treatment to Gaucher patients.
If you would like more information on this issue please contact firstname.lastname@example.org