The U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologic drugs that treat serious and chronic diseases.
In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing. The agency through a separate initiative also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily.
Expensive biologic medications make up only 5% of prescriptions in the U.S. but account for 51% of total drug spending as of 2024. FDA-approved biosimilars are as safe and effective as the branded drugs, yet their market share remains below 20%. To date, FDA has approved 76 biosimilars, corresponding to a small fraction of approved biologics. By contrast, there are more than 30,000 approved generics, exceeding the number of approved brand drugs. Only about 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development.
Currently, in some circumstances, developers perform “switching studies” for biosimilars licensed as interchangeable – a step not required for generic drugs. These additional studies can slow development and create public confusion about biosimilar safety. The FDA now generally does not recommend switching studies. As industries and authorities adjust to this change, Echa and industry experts will continue to monitor advances in this area.
Reference:
FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs | FDA
Today we announce that Exim is rebranding as ExSyn. We are presenting a new brand identity and website as a reflection of our relentless transformation over the course of 30 years serving the pharma and chemical industries. The new brand builds upon our core strengths as a sourcing company and captures our most essential duty: helping improve people’s health and lives.
As we approach the close of this year, we at ExSyn would like to extend our heartfelt gratitude for your trust, collaboration, and continued support. Your confidence in our products and services has been the driving force behind our growth and success.
Phosphatidylcholine (PC) is one of the most important phospholipids derived from soya lecithin and represents a key structural component of cell membranes. Phosphatidylcholine 90% refers to a highly purified grade where the PC content is enriched to around 90% through specialized extraction and purification steps.
Indorez® Kota Resin is a modified non self-cured phenolic resin, it can increase rubber adhesion to steel, polyester, rayon, nylon, aramid and other fabric cord. It’s an adhesive agent, acts as methylene acceptor, can 100% replace resorcinol and resorcinol resins in resorcinol- formaldehyde-silica, enhance adhesion between rubber and reinforcing materials.