In light of increased development and demand for biosimilars, as well as looming patent expiries, biologic developers are racing to release the next blockbuster biologic to replicate the success of past top-performers like Humira, and to prevent biosimilars from cannibalizing their market share.
The Insulin Price Reduction Act (IPRA) proposes to drive price reductions by drug companies by providing them with incentives to roll back the list price of insulin products to 2006 levels. Specifically, IPRA would make it illegal for pharmacy benefit managers (PBMs) and insurers to recover rebates from manufacturers that reduce the prices they charge wholesalers for insulin to those 2006 levels.
Knowing how to classify your device as either SR or NSR is not a clearly defined task. There are implications for each decision made as you proceed through development, and the burden is on you to understand and to provide what the FDA will require.
A host of factors come in to play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.
A team composed of nearly 70 FDA, pharma/biotech, and medical device leaders — spanning 39 organizations and five countries — have concluded that companies trying to get a handle on issues in their supply chains should focus less on their suppliers and more on themselves as the possible source of the problems.
Principles and methodologies for biopharmaceutical development and manufacturing are well established today. However, the increased molecular diversity and drive for higher productivity brings new challenges for process developers. One of these challenges is how to get deeper understanding for sources of variability and set mitigation strategies. This article shares some of our insights about how raw material variability is a potential source for process variation. The focus lies on chromatography resins.
Starting on Nov. 27, 2017, pharma manufacturers are required to begin marking all saleable units and homogeneous cases of prescription drugs with a unique serial identification code, as stipulated by the Drug Supply Chain Security Act.