- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Tahir Amin: Why US Consumers Must Wait for Adalimumab Biosimilars
Tahir Amin, DipLP, cofounder and director of intellectual property of Initiative for Medicines, Access, and Knowledge (I-MAK), explains the role of patents in delays to US adalimumab biosimilar launches.
Transcript:
The US market is going to have to wait for biosimilar versions of AbbVie’s drug Humira because the AbbVie has accumulated a number of patents on the drug. In fact, our study found they have filed over at least 247 applications for Humira. Many of these will expire in 2037 and as a result of the stockpiling of patents that AbbVie has compiled, it is going to delay biosimilars in the market at least until 2023, and I think what’s important about that is that the companies that have agreed licenses with AbbVie to enter the market in 2023 will still be paying royalties, according to reports, to AbbVie. So those are going to go back to the consumer as well, even when biosimilars come to the market, and AbbVie’s chief financial officer has actually gone on record and said that they’re quite pleased with their patent and legal strategy and this is why we’re not seeing earlier entry of biosimilars in the US market.
I think it’s also worth saying the regulatory procedure under the [Biologics Price Competition and Innovation Act] in the United States is different to that in Europe, so getting a biosimilar version on the market in Europe is less onerous…and that’s also why we see a quicker uptake in the market in the European market. It’s also worth mentioning that the number of patents that AbbVie filed were considerably fewer; in fact there were 3 times as many patents in the US than there were in Europe and almost 4 times in Japan.
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.
