Biotech Values

[DewDiligence]

Re: MNTA/PFE /FDA’s interchangeable-FoB guidance

On its 4Q16 CC, PFE was asked about the FDA’s recent guidance on interchangeable FoBs, and the non-answer was revealing, IMO:

http://finance.yahoo.com/news/edited-transcript-pfe-earnings-conference-025320336.html

Geoff Meacham (Barclays): I wanted to dig a little bit on the biosimilar franchise. What can you guys tell us about the Inflectra experience so far in the US, and what is the Pfizer view of the new interchangeability guidance and what it means to speed to market? [emphasis added]

John Young (Pfizer Group President): First of all, I think we obviously are very positive about the opportunity that we have with biosimilars. First of all, our commercial opportunity provides real value to our shareholders. But also the opportunity that biosimilars represent, to continue to bring some of the competition that Ian referred to the healthcare system, and to bring efficiencies and savings.

We think the opportunities in both regards are very significant. It's obviously very early days with Inflectra in the US. We are literally in the second month of launch, so it's early days.

We anticipate that the uptick in the first few months in the US will be slow. That represents our progress in Europe. Where we've seen that actually after the first few months as physicians get comfortable with biosimilars, we've seen the rate of uptick really begin to accelerate.

Just to give you data points to compare in Europe, the uptick of biosimilars overall for infliximab in Europe, is something like 28%, 29% in the second year. We're actually very satisfied with what we've seen about the progress that biosimilars can make when we begin to get information about how a high-quality biosimilar in our data can really, actually, deliver significant value to the healthcare system.

So, PFE’s executive never replied to the question about the FDA’s interchangeability guidance.

As a (possibly biased) MNTA long, I interpret this omission to be deliberate and to mean that PFE is not seeking FDA interchangeable status for its FoBs, including the FoB for Humira.