Adding to Dew's comments- Revance’s RT002 aka DaxibotulinumtoxinA is different from Allergan's Botox. To be clear- Revance adds a proprietary peptide to the botulinumtoxinA which is a major not minor difference from what Allergan has in Botox. From Wikipedia :
So by definition, since the active ingredient in RT002 is different from what is in Botox, RT002 cannot be approved as a biosimilar to AGN’s Botox. Probably more importantly, Revance would not want to call RT002 a Biosimiliar as they will try and market it as superior to Botox inasmuch as they are trying to prove it lasts longer and is safer.
I added the bold for emphasis. You almost have to read this several times to understand that they are saying RT002 is a different drug and separate from what Mylan and Revance are collaborating on.
IMO-Revance's own press release and comments in the quarterly cc regarding the agreement with Mylan have contributed to the confusion. They should have stated that the proposed biosimilar had nothing to do with RT002 and spent some time on this in the cc. Possibly Revance should put up some FAQ's in their investor section to address this confusion. I would suggest a few like: Q-Is the Mylan-Revance planned biosimilar based upon RT002? Ans- No, the biosimilar will be based upon the ingredients in Botox. The proposed biosimilar is a different compound than RT002. They are two different drugs. Q-Does this collaboration affect RT002 in any way? Ans- No- RT002 is 100% the responsibility of Revance.
I'm beginning to think that this proposed collaboration with Mylan is a bad thing simply from the standpoint of the confusion it is causing. It gives Allergan another way to insinuate that RT002 is a copy of Botox which it is not.