Replies to post #189993 on Biotech Values

[DewDiligence]

MNTA—In addition to the characterizations and assays performed by generic sponsors, FDA’s internal laboratory developed and performed its own testing of multiple batches of Copaxone, the proposed generic glatiramer acetate injection, glatiramer acetate-like products marketed outside of the United States, and negative controls, in each case using high-resolution analytical techniques.

This task presumably consumed a good portion of the 88 months during which the FDA had the ANDA.

[DewDiligence]

(MNTA)—RDY, Biocon not close to FDA approval for either 20mg or 40mg Copaxone, apparently. Following are excerpts from these companies’ most recent earnings calls (h/t @chiragontwtr). (Italicized comments enclosed in brackets are mine.)


CC excerpt for RDY (https://t.co/vo1QQu9hQP page 11-12):

[Analyst]: And just on Copaxone, is it possible to update on where your 20 mg file is?

[CEO]: As we communicated, we have filed the detailed response in the second week of December and it has gone into review. Our response also will have to go in but that is not main thing, the main thing is the DMF [DMF = drug master file for API] response. The ANDA response will go in by end March or so. And 40mg response will follow soon thereafter as well on the ANDA side. But the main thing, the DMF thing was in the second week of December.

[Analyst]: So, what is your expectation of approval, both for 20 mg and 40 mg?

[CEO]: That is a difficult question to answer, Sameer. As I said, we have good analytical capability, we think we have done a good job. Beyond that, I mean hopefully things do progress in the right direction.

[Analyst]: Is it part of your 15 launches [i.e. launches expected in the next year or so]?

[CEO]: Look, I mean, these are complex assets right, I mean, depending on what questions agency would be asking us, but there has been huge amount of scientific man hours which have been put in into this.

CC excerpt for Biocon (https://t.co/vo1QQu9hQP page 7):

[Analyst]: One final from my side and that's on Copaxone. Can you update us how has been the progress for a 20 mg file with FDA?

[CEO]: Sameer, at this point in time, we cannot give any guidance in terms of any
expectation of a near-term approval of Copaxone.

Based on the observations in #msg-112804827 and #msg-112812696, it’s hardly surprising that such companies as RDY and Biocon are struggling to meet the FDA’s high threshold for sameness to branded Copaxone.