Suzette Kox, MPharm, Secretary General of the International Generic and Biosimilar Medicines Association (IGBA), discusses the European experience with using nonproprietary names for biosimilar pharmacovigilance.
Transcript
It’s very straightforward: they can continue that policy. First, it is a scientific approach to allocate the same INN, international nonproprietary name, to the biosimilar and the reference product. That’s a scientific matter, that’s the first thing.
Secondly, we heard in the biosimilars conference today* again that there is a publication by European regulators and academics which has demonstrated that the identification of biologics—I think they looked into 10 different classes of biologics for which biosimilars exist—identification based on the INN and brand name is assured by 96.7%. So, it really works. And this will continue to work in the future.
*During the Medicines for Europe 17th Biosimilar Medicines Conference
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.