Pharmaceutical manufacturer AbbVie faces another legal challenge related to anticompetitive tactics in the US. On 12 October 2020, the US Public Interest Research Group (US PIRG) filed an appeal accusing AbbVie of employing tactics that have delayed market entry of biosimilars.
AbbVie accused of anticompetitive tactics to stop Humira biosimilars
Home/Policies & Legislation
|
Posted 30/10/2020
0
Post your comment
![24-AA011041 24-AA011041](/var/gabi/storage/images/media/images/24-aa0110412/30270-1-eng-GB/24-AA011041_large.jpg)
It is argued that biosimilar delayed market entry caused by AbbVie’s reverse payment settlements and creation of ‘patent thickets’ have costed American citizens billions of dollars. It is hoped that the outcome of this case will prevent further illegal abuses of the American patent system and deliver affordable treatment options to patients. The case was previously dismissed by the district court.
In a reverse payment – or pay-for-delay ‒ settlement, a patent holder pays a potential competitor not to sell their product for a period of time. This maintains originator monopoly and allows them to continue to charge high prices for drugs. A patent thicket is when a patent holder makes multiple, overlapping patents related to an originator product that work to extend its patent period.
It is alleged that AbbVie has used these anticompetitive practices to continually raise the price of Humira in the US. This is the world’s best-selling drug and is primarily used to treat rheumatoid arthritis. Its current price is US$72,000 per patient per year, which has more than tripled since 2006. However, biosimilars of Humira are available in Europe where AbbVie’s product can cost up to 80% less. The case’s brief states that in the US, Humira’s patent was due to expire in 2016, before it set up a patent ticket. When its competitors challenged this, they agreed to delay market entry until 2023 in exchange for earlier entry to the European market.
Related articles
Inter partes review and the generic drug industry
US policy brief identifies barriers to biosimilars uptake
Why does the US face high-priced generics and drug shortages?
Adalimumab copy biological shown to be safe and effective
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.
Guidelines
Regulatory update for post-registration of biological products in Brazil
New regulations in Brazil for the registration of biosimilars
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
NPRA Malaysia trials new timelines for variation applications
![24-AA011041 24-AA011041](/var/gabi/storage/images/media/images/24-aa0110412/30270-1-eng-GB/24-AA011041_large.jpg)
Home/Policies & Legislation Posted 05/11/2024
Regulatory evolution and impact of simplified requirements for interchangeable biosimilars in the US
![19646665_l 19646665_l](/var/gabi/storage/images/media/images/19646665_l2/55733-1-eng-GB/19646665_l_large.jpg)
Home/Policies & Legislation Posted 18/09/2024
China’s NMPA expands global ties with the Netherlands and Indonesia
![China CFDA NMPA China CFDA NMPA](/var/gabi/storage/images/media/images/china-cfda-nmpa/80817-1-eng-GB/China-CFDA-NMPA_large.jpg)
Home/Policies & Legislation Posted 04/09/2024
Japan's PMDA expands influence with new office in Thailand
![Conference V14A17 Conference V14A17](/var/gabi/storage/images/media/images/conference-v14a172/21555-1-eng-GB/Conference-V14A17_large.jpg)
Home/Policies & Legislation Posted 06/08/2024
The best selling biotechnology drugs of 2008: the next biosimilars targets
![picture09 picture09](/var/gabi/storage/images/media/images/picture09/2207-2-eng-GB/picture09_large.jpg)
Post your comment