Posted by Michael Wonder on 28 Mar 2018
To make copycat drugs more competitive, the FDA is taking a harder look at the originals
28 March 2018 - The FDA wants to improve branded drugs to help bolster the biosimilars market.
The Food and Drug Administration wants to focus on improving pricey biotech drugs so that replacing them later with cheaper "biosimilars" would be easier.
One problem for companies trying to create these medicines is that branded biologics can change over time, requiring them to test more patients to prove biosimilars are as effective as their branded peers, FDA Commissioner Scott Gottlieb said in an interview with Meg Tirrell at CNBC's "Healthy Returns" conference on Wednesday.
To combat this, the FDA wants drugmakers to minimise the variables in the manufacturing of branded biotech drugs. That would help bolster the biosimilars markets because less variance should mean faster approval of the medications.
