Being terminated? Come to Coherus

Coherus has been telling investors that their manufacturing partner, KBI Biopharma, has cleared up their problems from their disastrous December FDA inspections and that the FDA has approved of KBI's actions. Not True! The FDA is on KBI's case for operating in violation of dozens of FDA regulations. Coherus lied to their investors!

 

Not so fast Sparky...

June 9, 2017 is the PDUFA date for the Coherus biosimilar of Neulasta and there has been no Advisory Committee Meeting scheduled nor conducted to date - at least not at the last Oncology meeting when the Pfizer biosimilar of Epogen/Procrit was approved. FDA has so far conducted Ad Com Meetings for all first entry biosimilars.

Then there is the "707" process/manufacturing patent that Coherus must overcome from the May 11, 2017 law suite recently filed by Amgen as part of the "patent dance" submission from Coherus.

Along with the previously noted law suit in this thread on trade and company proprietary information brought over and used by Coherus from ex-Amgenites - allegedly.

To make matters potentially worse, manufacturing is contracted with KBI - Coherus will not be manufacturing their biosimilars. KBI has their own manufacturing issues and FDA 483s to deal with right now. Last time I checked, launching a product actually requires a finished product to sell.

Maybe, maybe not so soon Sparky. A lot of uncertainties for Coherus. We'll know how this game plays out in the next few months.

 

Coherus management is made up of ex-Amgen management from Clinical Development, Manufacturing, Sales and Marketing including C-Suite executives. All worked on or had under their Amgen roles Neupogen/Neulasta and Enbrel of which Coherus is making their own biosimilars (along with Humira). Should be an interesting collision in the marketplace when launched. Hahahahahahahaha.

 

Tell me, where do I sign up?

 

How did Coherus' June 9th PDUFA go?

 

Crickets are chirping. Nothing from FDA or Coherus. IF Coherus received an approval on their biosimilar Neulasta, it would have been broadcasted by Coherus to all loud and clear. Maybe the FDA is just taking a few more days or weeks to decide OR give will Coherus a Complete Response Letter. Crickets are chirping.

 

FDA rejects Coherus' marketing application for Neulasta biosimilar; shares down 34% premarket
Jun. 12, 2017 7:29 AM ET|By: Douglas W. House, SA News Editor


Coherus BioSciences (NASDAQ:CHRS) has received a Complete Response Letter (CRL) from the FDA related to its Biologics License Application (BLA) seeking approval for CHS-1701, a biosimilar to Amgen's (NASDAQ:AMGN) Neulasta (pegfilgrastim).

The CRL cited the need for a reanalysis of a subset of subject samples with a revised immunogenicity assay and additional manufacturing-related process information.

The company says it will work with the agency to address the issues. Management will host a conference call this morning at 8:00 am ET to discuss the situation.

Shares are down 34% premarket on average volume.

 

Denied by FDA. Coherus is screwed.

 

buh bye

 

Maybe all of us in the OBU should send sympathy cards to Jim Daly, Jim Hassard and Chris Thompson at Coherus just to let them all know we still care?

 

That's what happens when you ask KBI Biopharma to manufacture your product! Everything they do is a disaster!

 

Coherus' shareholders have even turned on them:

http://www.sbwire.com/press-releases/coherus-biosciences-inc-nasdaqchrs-shareholder-notice-investigation-announced-824265.htm

 

Come work at Coherus???? Coherus just laid off 30% of its workforce!

 

I guess the ex-Amgenites Daly, Hassard and Thompson are now ex-Coherusites. Bahahahahahaha!

 

Coherus in more trouble, they had to fire their fill-and-finish company:

CHRS BLA for Humira FoB delayed to 1H18 due to fill/finish problems:

https://www.sec.gov/Archives/edgar/data/1512762/000119312517213200/d389037d8k.htm

 

Daiichi Sankyo gave up on Coherus and refuses to make or sell CHS-0214 in Japan. Coherus loses the Asian market.


http://getfilings.com/sec-filings/170705/Coherus-BioSciences-Inc_8-K/

 

i would stay put

 

oh yes- leave and join this rocketship

 

Coherus is sinking faster than the Titanic!

 

Coherus is a "virtual biotech company" with borrowed Asia R&D, contract manufacturing, CRO for clinical development and ex-Amgen commercial/C-suite leadership with no products until at least 2018 - 2019. Nothing here.