- Click here for the transcript of Merck's presentation at the Bank of America Merrill Lynch Global Healthcare conference on 9/15/2011.
- See below for some excerpts and comments regarding MRK's plans in the field of biosimilars.
- Click here for archive of all of my blog posts related to biosimilars/biogenerics/follow-on biologics.
"you mentioned your biosimilars, three products in the clinic in 2012. Just curious if you could give us a sense of when you think they might actually enter the market, especially because there is some IP out there I think on theNeupo products.
So on the biosimilars front, we do have the three that I mentioned that we have identified now.We hope to have another two in development by the end of 2012. So the three I mentioned, none of them are in Phase III development right now.They're all getting ready at some point to start Phase III. So we want to be prepared that when all of the IP issues are resolved around these programs, that we will be able to enter the market shortly after the resolution of those IP questions. So I don't want to give you a specific time for when the Neupo productswill enter or when the biosimilar Enbrel; but just say that our goal is to be ready to enter as soon as those IP issues are resolved"
"And just to re-ask on the biosimilars front, to what extent are you waiting for US regulators to shape the path forward? Versus maybe you are just going full BLA like Teva, for example, is doing
Yes, so I think that there are different approaches here. I think that we are not at this moment pursuing the full BLA approach. We are trying to work in lockstep with the FDA, and we are trying to collaborate with them as they develop their pathways. We want to be a part of that. So that if we can give some input or some suggestions we would like to be a part of that, but also
to be aware of what they are planning. So I think we would rather align with the FDA than to try to pursue some kind ofabbreviated BLA, which I am not sure that that pathway really exist"
"To be in Phase III by the end of '12 suggests that you are either doing or hope to do some Phase I work. So you are not going to skip to right to Phase III, right
That's correct. So Phase I work, our view is that Phase I work would be required; and that hopefully you skip the Phase II workand then just do, to a limited degree, some Phase III programs"
"Just a follow-on, on the biosimilars. You mentioned FDA. I think the European final guidelines are due out shortly. We have obviously seen the draft last year.Are you expecting any major changes from those? I guess you have been involved in discussions there
On the biosimilars front in Europe, we are waiting for those final guidelines. I think at this point we don't see anything that is different than what we expected or anticipate in Europe. I am not as close to it as other people inside the Company; but I am not hearing of anything that is a surprise there"