- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Suzette Kox, MPharm: Bridging Studies and Biosimilars
Suzette Kox, MPharm, secretary general of the International Generic and Biosimilar Medicines Association (IGBA), discusses the need to waive bridging studies in biosimilar development.
Transcript
We need to make really substantial progress on waiving of bridging studies where the comparator products used are just another version of the local reference product.
So how are we going to do that? I think we have of course the excellent publication of Christopher J. Webster and Gillian R. Woollett, DPhil, which has laid the scientific basis for this reflection that eventually we have only 1 comparator product on the market, which should be the basis for the biosimilar development. That’s one thing.
But how do we get this forward? Because the science is there, because these products are based on the same clinical data package, even versions which are on the market around the world. I think what we are probably going to do is of course we’ve had some interaction with some agencies. We’ll further talk about it at different conferences to get the ball rolling, keep the momentum.
It should be a key priority for the [IPRP, the International Pharmaceutical Regulators Program], there is a biosimilar working party, and the IPRP (it was formerly IPRF); this is for me the largest forum for the moment where biosimilars are discussed, and it should be a key priority to look into that.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
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.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
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.
