Shire v Genzyme

Material for an advisory group

Corrective statement

On 26 February 2014, Genzyme Therapeutics Limited presented information about the use of Fabrazyme (agalsidase beta) in Fabry’s Disease to a meeting of the Lysosomal Storage Disorders Expert Advisory Group (LSDEAG). I am writing to you because you were at that meeting and/or received papers provided by Genzyme for pre-circulation.

Following a complaint by Shire Pharmaceuticals Limited under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Appeal Board ruled that Genzyme’s material was, inter alia, inaccurate, unbalanced and misleading. Particular concerns were raised about statements relating to the dose and cost of Fabrazyme vs Replagal (agalsidase alfa, marketed by Shire) and the description of the two as being ‘biosimilar’. Some statements were inconsistent with the Fabrazyme summary of product characteristic​s (SPC). The materials thus fell short of the quality standards expected from a pharmaceutical company.

As a result of the above, Genzyme has been required to circulate a copy of the published report for the case which contains full details and this is enclosed.

Genzyme arranged for copies of the interim case report and the company's corrective statement to be emailed to those who had attended the advisory group meeting or who had received copies of Genzyme’s materials prior to the meeting. The materials were sent on 18 March 2015.

Date posted 7 April 2015