J&J adds its opinion to biosimilars naming debate

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J&J adds its opinion to biosimilars naming debate

Biosimilares/General | Posted 10/01/2014 2 Post your comment

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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References

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars naming debate intensifies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-naming-debate-intensifies

2. GaBI Online - Generics and Biosimilars Initiative. Calls for biosimilars to have same INN at WHO meeting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 10]. Available from: www.gabionline.net/Biosimilars/General/Calls-for-biosimilars-to-have-same-INN-at-WHO-meeting

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Source: J&J

Comments (2)

Post your comment

Posted 16/01/2014 by Jodi H, GaBI Online Editorial Office

Response to ‘INN names for biosimilars’

Dear Mr Levine,
Thank you for your comments. We would be delighted if you would consider submitting a Letter to the Editor of GaBI Journal on this topic. If interested, please feel free to reach us at editorial@gabi-journal.net. Thank you again and we hope to hear from you soon.
Best regards,
Jodi

Posted 14/01/2014 by Howard Levine

INN names for biosimilars

As we stated in our blog last month on this topic, we agree with WHO and a bipartisan group of US Senators that biosimilars should share the same non-proprietary name as their reference products. We believe that there are other mechanisms, such as the European Commission's directive 2012/52/EU that requires biosimilars to be identified by brand name rather than INN, which will better serve to ensure patient safety without the potential confusion that might be caused by issuing different INNs to each biosimilar version of a reference product.