Lilly, Novo Nordisk fight insulin biosimilars with tweaks to FDA draft guidance
As Americans with diabetes continue to die because they cannot afford their insulin, two of the three insulin manufacturers in the US are doing their best to try to alter FDA draft guidance that seeks to bring more insulin competition to market.
The draft guidance, unveiled last November, explains how insulin biosimilar developers may not need to conduct comparative clinical immunogenicity studies under certain circumstances.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.