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Consultation - Guide to Biosimilars for Healthcare Professionals

News Category: Regulatory news

Date: 25/11/2019

Start date of consultation:        25 November 2019
Closing date of consultation:   23 December 2019


The HPRA Guide to Biosimilars for Healthcare Professionals and Patients has been updated. The guide was originally published in 2015 and since that time there has been an increase in clinical and regulatory experience with this class of medicines as well as a growing body of scientific literature. The updated guide is now aimed solely at healthcare professionals, as the HPRA published a separate guide and information video for patients in 2017. The updated guide also provides further clarification of the HPRA’s position on interchangeability, switching and substitution.

The HPRA welcomes comments on this updated guide and there is a consultation period of 4 weeks. All comments should be sent to biosimilarconsultation@hpra.ie. Please see below for links to clean and tracked changes versions of the proposed document.
 
Guide to Biosimilars for Healthcare Professionals v2.2
Guide to Biosimilars for Healthcare Professionals v2.2 (tracked changes)

Further information will be available from the consultations page on our website. 

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