Found this while trying to understand the lifecycle of biosimilars vis-à-vis the patent dance.
apologies for multiple posts - found couple of additional good links . Biosimilar story seems largely on course
Thanks Gary24, every bit adds to the pictures on both sides : the risks and the
great potential. It reinforces: it is a very complex picture, to remain alert and follow
up is imperative.
I’ve started doing this but couldn’t quite complete yet. Idea is to get consolidated view of next 18 odd months of expiry and potential large shifts and thereby see who has the upside.
Can I request thoughts whether something like this makes sense ? May be others already have a fairly detailed view that was elusive to me? If it does, comments / suggestions welcome on how to improve and if someone wants to contribute, even better.
PS: I"m posting this on biocon thread because the top ones - Humira etc. are biocon plays.
Large number of observations wrt good manufacturing practices by EMA regarding three important biosimilars (Trastu , peglig…, Insulin glargin) filed by biocon at European regulators (EMA). Out of some 34 observations some 11 are of major nature. How would the experts judge it, teething trouble which will be rectified in due course or big setback indicative of larger recurring problems. To me it seems to be the first rather than second. What does leading lights of the forum says on the issue. @rks00 @hitesh2710
Biocon-Limited-Fails-EDQM-Inspection-1499504133.pdf (149.9 KB)
Letter issued by french authorities.
why this news would surface now as inspection was done in March. This looks like speculators making the move but lets see.
Reports r issued with a time lag. See the letter.
company’s clarification to the stock exchanges -
Can’t reconcile the two letters.
Inspection authorities letter says non compliance of GMP (General manufacturing practices) and biocon says
It has received compliance. Is there another letter ? or it is very creative Interpretation by biocon.
There appears to be another approval related to “drug substance manufacturing facilities” [ see the last para that says that "manufacturing activities of Trastuzumab and Working Cell Bank Pegfilgrastim are not concerned by this GMP part II … ".
However, even in the previous para , Biocon claims that "while there no critical observations… " - That clearly is stretching the truth and leaves me in doubt of Biocon management’s integrity and transparency.
disc ; Invested ~ 3% of portfolio
Gary, management’s response is technically correct, as the EU GMP process seems to list 3 categories of observations possible in their audits - critical, major and others. The report itself classifies 11 of the observations as ‘major’. So this may be technical jargon.
There is a clarification in the bottom of the GMP letter stating that compliance certificates have been issued for manufacturing facilities linked to trastuzumab and pegfilgrastim
They didn’t receive any observation for Insulin Glargine Pens facility.
They have already received GMP approval for both drug substance facilities.
Only the approval for drug product facility which produce Trastuzumab and Pegfilgrastim is pending. They plan at seek reinspection at early date.
Does anybody has recent update reports from Morgan Stanley (TP 421) and Citi (TP 405) OR Links? Please share.
FDA Briefing Document Oncologic Drugs Advisory Committee Meeting July 13, 2017 BLA 761074 MYL-1401O, a proposed biosimilar to Herceptin (trastuzumab) Applicant: Mylan Pharmaceuticals
FDA Briefing document conclusion : `In considering the totality of the evidence and the established scientific bridge between EUHerceptin,MYL-1401O, and US-Herceptin, the data submitted by the Applicant show that MYL-1401O is highly similar to US-Herceptin, notwithstanding minor differences in clinically inactive components, and support a demonstration that there are no clinically meaningful differences between MYL-1401O and US-Herceptin in terms of the safety, purity, and potency of the product.
Regarding Manufacturing Process: ` The data provided demonstrated that the MYL-1401O drug substance manufacturing process sufficiently reduces the impurities to very low levels (e.g., ppm for HCP and pg/ml for HCD)
Have brought this from BIOCON Board, MMB where I am a regular. Posted by a fellow boarder.
Should it not work, kindly type the key words from my first post.
Thanks for sharing the information, was going through the FDA site and saw this as well. Below is the link to the detailed document elucidating the safety, efficacy & biosimilarity of Herceptin & MYL- 14010
Note - This is NOT the final verdict, this document is purely for internal purposes and reflects the view of the team during one stage of the review process. That being said, this is an extremely positive development.