On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
FDA Announces Policy for Unique Nonproprietary Names for Biologics and Biosimilars
Essentially, FDA is proposing a unique nonproprietary naming policy for all biologics approved under PHSA 351(a) or 351(k). While ending some speculation on FDA’s policy toward naming of biosimilars, the guidance seeks extensive input from stakeholders regarding the application of a four-letter suffix to distinguish all biologics and biosimilars from one another and whether interchangeable biologics should similarly have unique suffixes or share the same four-letter suffix. FDA summarized its intention with this policy:
“By differentiating biological products from one another that have not been determined by the FDA to be interchangeable, this naming convention is intended to help minimize inadvertent substitution. Inadvertent substitution may lead to unintended alternating or switching of biological products that have not been determined by FDA to be interchangeable. A naming convention that differentiates among biological products also could help facilitate pharmacovigilance for all biological products. By applying this naming convention to all biological products, this approach is intended to: (1) Encourage routine use of designated suffixes in ordering, prescribing, dispensing, and recordkeeping practices and (2) avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathways.”
In the accompanying proposed rule, FDA provides additional details on its proposed naming policy and the application of this policy to six products. Each of the six products is either a reference product for an approved or publicly disclosed biosimilar product application or a biological product that is either biosimilar to or related to one of these reference products.
Comments on the guidance, which has been assigned Docket No. FDA-2013-D-1543, are open through October 27, 2015. (Although, per FDA regulation, comments on a guidance may be received at any time.) Comments on the proposed rule, including the assignment of proper names, should be sent to Docket No. FDA-2015-N-0648, which is open through November 12, 2015.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017