By Anna Rose Welch, editor, Biosimilar Development
I reached out to learn the inflammatory arthritis patient community’s thoughts on British Columbia’s (BC's) large-scale transition to biosimilars. I also wanted to know which best practices the government employed behind the scenes to ensure the policy would be a success.
A race is being run to create the pharmaceutical manufacturing of the future, and with Pharma 4.0, powerful market trends are shaping the running field. While the focus of Pharma 4.0 is the manufacturing supply chain, the principles are being applied in a much broader fashion across the entire drug development life cycle.
The Insulin Price Reduction Act (IPRA) proposes to drive price reductions by providing drug companies 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.
This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part we will discuss the needle-free PFS and the dual-chamber system.
Biacore SPR assays provide an automated and reproducible real-time determination of active concentrations that can be considered an alternative to traditional ELISA approach. This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR-assay, and by doing so, shows how you can get results in less than half the time compared with ELISA.