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Tuesday, 09/19/2017 4:45:13 PM

Tuesday, September 19, 2017 4:45:13 PM

Post# of 3283
Good move SPPI not going the biosimilar route. Just read a Bloomberg article where only 3 of the 7 FDA-approved biosimilars are available for sale. As you know Rolontis will be competing w Neulasta but will have its own J-code and is not considered a biosimilar. All the Neulasta biosimilars so far are having difficulty getting approved but as this article points out, even if FDA approved, the original drug manufacturers still make it difficult by throwing a patent wall that you need to hurdle before selling it on the market. Here's the link to the article titled FDA Clears Biotech Drug Copycats, But Buying Them Isn’t So Easy

https://www.bloomberg.com/news/articles/2017-09-18/fda-clears-biotech-drug-copycats-but-buying-them-isn-t-so-easy?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=health-care

Edit - I neglected to say why. There's less hoops you have to jump through to get FDA approval. For instance, if you went the biosimilar route, you'd need to do a bioequivalence study as compared to the randomized study for Rolontis. Much less of a hurdle for the biosim.