A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. -FDA If you want to bring a biosimilar to market, you’ll need to demonstrate that it is highly similar to the reference product in both structure and Read more…
There is no single method that is solely decisive for a conclusion on biosimilarity of acertain candidate. But we can talk about streamlining the demonstration on biosimilarity. Demonstrating Biosimilarity According to the FDA, the approval of a biosimilar should be based on the integration of different information using a totality-of-evidence Read more…
The biosimilars market has always been of great interest. However, since 2019 this interest has increased even more, due to the published FDA guidance on demonstrating biosimilar interchangeability. And just like that, the quest for interchangeability began! Despite the need to provide additional information or data to demonstrate interchangeability, this Read more…
Who doesn’t like a good story, especially when it has a happy ending? That’s the case of this 4TE story, where we helped a company with their biosimilar product approval. So, fasten your seatbelts and join us in finding out how we helped a company avoid massive time-to-market delays and Read more…
Biosimilars have been experiencing an impressive growth in the last few years. And it’s no wonder because Biosimilars have, on average, a high rate of cost-effectiveness. This is becoming much more important in a world where chronic diseases are more common and there’s a growing pressure to reduce healthcare spending. Read more…