In the ongoing saga over how to name biosimilars healthcare giant Johnson & Johnson (J&J) has added its opinion to the melting pot; petitioning the US Food and Drug Administration (FDA) to give biosimilars similar, but not identical names, to those of the originator biological products.
The Janssen Pharmaceutical Companies (Janssen) of J&J submitted a Citizen Petition to FDA on 8 January 2014 asking the agency to require biosimilars to bear non-proprietary names that are similar to, but not the same as, those of their reference products or of other biosimilars. The petition states that distinguishable names are essential for enhancing patient safety and to ensure effective pharmacovigilance.
Dr Jay P Siegel, Chief Biotechnology Officer and Head of Scientific Strategy and Policy at J&J, argues that distinguishable names are ‘of critical importance for patient safety’. He adds that ‘names that are similar but not the same will appropriately reflect the legal and scientific reality that biosimilars are similar to but not the same as their reference products or other biosimilars’.
According to the Janssen Citizen Petition, the naming of biosimilars could have important patient safety implications beyond the name itself, including pharmacovigilance, product switching and extrapolation of indications. Dr Siegel highlighted ‘the need for reliable pharmacovigilance mechanisms for detection and investigation of post-marketing safety signals, the importance of the ability to identify precisely which product a patient has received and the risks associated with inadvertent switching between products’.
The Janssen Citizen Petition is just the latest in the ongoing debate surrounding naming of biosimilars. In October 2013, a letter was sent to FDA by a bipartisan group of US senators calling for biosimilars to have the same active ingredient name as the brand-name originator product. Swiss drug giant Novartis also submitted a petition to FDA on 30 October 2013 calling for biosimilars to ‘share the same International Nonproprietary Name (INN) as the reference product. Originator biologicals developer Amgen, on the other hand, supports the use of distinguishable names [1]. During the World Health Organization’s meeting on INNs, pharmaceuticals stakeholders, including the European Generic medicines Association (EGA), called for biosimilars to be assigned the same INN as their reference biologicals. While others, including the Alliance for Safe Biologic Medicines (ASBM), called for the use of distinct non-propriety names for biological medicines [2].
Editor’s comment
What do you think about the biosimilars naming debate? Please feel free to share your thoughts via email or in the comments section below. How should biosimilars be named? Should biosimilars have unique INNs or should they share the same INN as their reference biologicals? How will safety be affected by any decision over naming of biosimilars?
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Source: www.gabionline.net
