Great post by JD. Thanks for sharing Preclin. A few additional comments.

There was a great article/video by Damian Garde of Stat News the other day on the generic chemicals vs. generic biosimilar topic. Very good points that unlike generic chemicals, there is a lot more that goes into manufacturing a biologic like an antibody that presents additional patent, manufacturing and clinical hurdles that a generic chemical does not have to face. Not all herceptin biosimilars may elicit the same clinical effect. Biosimilars are subject to more variability and have additional burden of proof to show the same efficacy as the original product. I haven't looked in depth at JDs articles he referenced, but they may touch on that issue too.

What is a biosimilar, exactly?

Also, I need to clarify my point for mentioning MacroGenics' margetuximab, which also applies to Roche's T-DM1-enhanced Herceptin (Kadcyla) as JD pointed out. I was not implying that BiOasis abandon xB3-001 (the xB3 version of Herceptin). I fully appreciate that xB3-001 is the lead internal program for BiOasis. Instead, I was attempting to imply that if other companies such as Roche and MacroGenics appreciate that their Kadcyla or margetuximab antibodies are still limited in their ability to cross the BBB to treat brain metastases, despite possible improvements in peripheral efficacy, then they may be interested in licensing the xB3 from Bioasis. Whether Bioasis agrees to license xB3 to competitors of xB3-001 is another issue. I was simply bringing attention to the commercial licensing arm of things. But in the case of the xB3-001 internal program, there may be additional considerations if the licensee is developing a product that could compete with the licenser's lead internal product.