AbbVie delayed biosimilar competition to Humira “for far longer than warranted” and may have “engaged in other anti-competitive conduct to maintain its market share and pricing power” for the adalimumab brand, according to members of the US House of Representatives’ committee on oversight and reform. The US Federal Trade Commission has been urged to open a formal inquiry into the originator’s conduct.
AbbVie has come under fire in the US for using its intellectual property strategy around Humira (adalimumab) to delay biosimilar competition, as well as engaging in “other anti-competitive conduct to maintain its market share and pricing power” for the top-selling biologic arthritis treatment.
Suggesting that the originator’s actions delayed biosimilar competition to Humira “for far longer than warranted,” until 2023, members of the...
An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.
