|Company Name:||Amgen Inc.|
|Event Title:||Citi 8th Annual Biotech Conference Transcript|
|Event Time:||02:00 PM ET|
Yaron Werber, M.D.
Director and Sr. Analyst, Citi
Okay, I think we are ready to get started. Well, thanks everybody and welcome once again to the 8th Annual Citi Biotech Conference here in Boston.
It’s really a great pleasure to move on to a very much a hot topic of Biosimilars. And we really have a very distinguished panel here with us to talk about what are the challenges and opportunities for both branded and biosimilar drug makers.
Let me introduce Liav Abraham all the way on the left. You all know he is Citi's Specialty Pharma and Generics Analyst. Liav is going to co-moderate the panel with me.
And then I'd like to introduce Scott Foraker, who is Vice President and General Manager of Biosimilars at Amgen. He is right here in the middle.
To my immediate left is Tom Wintner who is an associate at Edwards Wildman & Palmer which is a law firm here in Boston. And there’s not a ton of attorneys so far who has really written extensively about biosimilars because this is a very new area as you can imagine and Tom actually has done quite a lot of work and I think this is really going to be one of the focus for his career.
And then to our left is Michael Rice who is Senior Consultant at Defined Health, which is a strategy management consulting that's specifically focused on biopharma. So everybody thanks so much for coming, really appreciate it.
Scott, let’s maybe start with you because Amgen is in a very interesting position that you're both kind of a defender of your branded products but at the same time you guys really have a lot of expertise in-house manifested in the partnership obviously with Actavis on biosimilars. So, you've kind of a lot that you can share with us.
So, one, let’s discuss some of the things that we've seen so far is companies in this space like Teva, like Biogen and Samsung that have had some setbacks looking at Rituxan and Merck had a snag in both Aranesp and Enbrel and as a result Merck now partners to create what's known as Samsung Bioepis which is Biogen, Samsung and Merck partnership .
What are some of the challenges that are facing biosimilars who are trying to come to market, technological, resource, capability, regulatory?
Vice President and General Manager, Biosimilars, Amgen
So I would characterize the problems or issues or challenges really into two categories, one technical and the other is capital. So let's start with capital.
So just to get into this business very capital intensive business which is going to place some limit on those that can play. And I'm talking about the developed markets primarily the U.S. and the EU where the regulatory bar will be high. The showing of biosimilarity requirement is high. And so the technical requirements are going to just be very, very challenging to show that you can have a highly similar drug.