Pfizer announced November 18th that the biosimilar licensing application (BLA) for its adalimumab biosimilar was approved by the Food and Drug Administration (FDA). The drug will be marketed under the name Abrilada™ (adalimumab-afzb) in November 2023, according to the terms of a licensing agreement with AbbVie. According to Pfizer, the drug was approved for … Continue reading Pfizer Reaches Milestone: FDA Approves 25th Biosimilar in US
Tag: biosimilar approvals
New Proposal: Forget Biosimilars, Move to Fixed Price Formulas
Claiming that US savings would accrue from $200 billion to $300 billion within 5 years, a group of authors published in a Health Affairs blog a different concept for controlling the cost of biologic agents. They believe that biosimilars will never gain the savings intended by the Biologics Price Competition and Innovation Act (BPCIA). Savings … Continue reading New Proposal: Forget Biosimilars, Move to Fixed Price Formulas
Comparing Biosimilar Approval Progress by the FDA and EMA
It is widely reported that European biosimilar development is way ahead of that in the US. In a number of ways, this is true. However, when talking about biosimilar development in the EU compared with the US, we really should take a look at the bigger picture. First of all, let me specify that I’m … Continue reading Comparing Biosimilar Approval Progress by the FDA and EMA
Will the Government Shutdown Slow Biosimilar Approvals?
The partial federal government shutdown is having specific effects in various important areas of government, but it may not be particularly troubling for FDA user-fee funded activities. Scott Gottlieb, MD, Commissioner of the FDA, has been especially busy on Twitter, trying to inform the public how the government shut down is affecting FDA operations. He … Continue reading Will the Government Shutdown Slow Biosimilar Approvals?