Tilda Dead before Launch, Patient Death

[anonymous]

Problems in SOUTH KOREA!
Samsung Biologics, who will make Tildra....

To sell drugs into the U.S. or Europe, foreign plants must pass inspection by those markets’ drug regulators. Both Korean producers have done that, but the U.S. Food and Drug Administration recently found deficiencies at a Samsung Biologics plant that led the FDA to slap them with a warning letter. The regulator typically won’t approve new products by a manufacturer until such problems are resolved, so the required fixes may delay U.S. approval.
While biosimilar treatments are being promoted by Europe’s national health programs, the reception by U.S. doctors has been cool. Samsung Biologics Remicade-like biosimilar has more than 100,000 patients across Europe. A U.S. version that it launched with Pfizer in 2016 IS STRUGGLING FOR MARKET SHARE!

 

[anonymous]

Frannie, Seema:
It's over.
It's ok now, you can leave.

 

[anonymous]

If I was given just two words to describe SUN, very simply, it'd be

"SHIT SHOW"

Period. Total shit show.

 

[anonymous]

I still can’t believe I ever worked there. I would like to think it was a bad dream. Actually a nightmare!

 

[anonymous]

Hey Seema, How's that PRE-PROMOTION of Tildra going? You know, the one that is AGAINST FDA rules?

 

[anonymous]

You should also ask Fran, Vimal, Bruce M, Mike B, D Fad, Vimal and Kyle.

They're all going to get dragged in -

 

[anonymous]

You must really have it out for Vimal have him dragged in twice!

 

[anonymous]

The sales team in particular is very sad ...

Don't worry too much, the pain will be over sooner than you already think.

WTF are you guys doing in the field anyway ? Disease state knowledge ? Yeah, there's something new. Fran and Seema, when they 'work', they're hosting dinners and talking product.

Sun is frickin' crazy - huge exposure for the Company.

Fran and Seema....leading the pack in NON-COMPIANCE...

 

[anonymous]

You must really have it out for Vimal have him dragged in twice!

Maybe he is twice as bad?!? Just sayin...

 

[anonymous]

Hey Seema, your reps talking to docs PRIOR to Tildra approval has been noted by the FDA....

 

[anonymous]

FDA needs to SHUT SUN DOWN!!!!! Seriously Tildra reps are going out promoting prior to approval, FACT!

I feel bad for the handful of good reps Sun talked into working for them by offering a high salary or snagging them just after a layoff.

The majority of reps I see they have hired are from companies notorious for clueless, entry level people. These will be the people who break the rules and get the handful of poor folks who are good and compliant all in trouble for their clueless promoting prior to approval. Too bad Sun's reputation kept most quality reps from being willing to work for them.

 

[anonymous]

I feel bad for the handful of good reps Sun talked into working for them by offering a high salary or snagging them just after a layoff.

The majority of reps I see they have hired are from companies notorious for clueless, entry level people. These will be the people who break the rules and get the handful of poor folks who are good and compliant all in trouble for their clueless promoting prior to approval. Too bad Sun's reputation kept most quality reps from being willing to work for them.

Lynch, Trusty and Kane have unconscionably been putting on the fake face and telling people what a great place this is. They should be ashamed putting their personal monetary gains ahead of people making career decisions which impact their families.

And for compliance and off label promotion - Sun has been warned, make no mistake about it.

It's all documented, and when the OIG comes in, Manzano, Davis and Gandhi will have no defense. Gandhi will have his passport revoked and he'll be wearing an ankle bracelet.

There will be a line of current and former employees willing to testify.

#sundown

 

[anonymous]

I feel bad for the handful of good reps Sun talked into working for them by offering a high salary or snagging them just after a layoff.

The majority of reps I see they have hired are from companies notorious for clueless, entry level people. These will be the people who break the rules and get the handful of poor folks who are good and compliant all in trouble for their clueless promoting prior to approval. Too bad Sun's reputation kept most quality reps from being willing to work for them.

LOW LOW quality reps hired for Tildra overall. They're just sitting around in their PJs waiting for the approval...oh and going out and talking to docs pre-approval! Don't think for a minute they will only discuss "disease state" with these derms....they'll be talking TILDRA and guess what you clueless Sun reps, the FDA is watching and has providers ready and willing to REPORT SUN's prior approval promotions!

 

[anonymous]

Probably will be waiting to launch Tildra for yet another year, or until they can find a manufacturing site that meets US-FDA standards. For kicks, let's just say that the Tildra team really is talking up disease state. The team has to be pre-selling Tildra or they are simply talking about what frosting that the doctor requested on their Dunkin Donut! By this point in the biologics for psoriasis game, what exactly does SUN really think they are teaching? If a dermatologist is not aware of the biologic differences and the receptors that they turn on/off, then they probably should not be a target. Biologics 101 and 102 are covered with just about the same slides at every dermatology meeting every week of the year!

Stupid is, what stupid does!

 

[anonymous]

I mean what else could go wrong for Sun ?

The manufacturing site (Samsung), is under heavy fire from FDA which may indefinitely delay Tildra.

Halol, the company's largest mfg. facility has been shut down for two years by FDA, and as recently as last month, not all issues have been resolved.

#absoluteclusterfuck

 

[anonymous]

You left off contamination of Halog topical steroid causing backorder. Even the contract manufacturers cannot get it straight! Good thing sales are down on Absorica, since the tropical storms probably took down the Puerto Rico capacity too.

 

[anonymous]

Probably will be waiting to launch Tildra for yet another year, or until they can find a manufacturing site that meets US-FDA standards. For kicks, let's just say that the Tildra team really is talking up disease state. The team has to be pre-selling Tildra or they are simply talking about what frosting that the doctor requested on their Dunkin Donut! By this point in the biologics for psoriasis game, what exactly does SUN really think they are teaching? If a dermatologist is not aware of the biologic differences and the receptors that they turn on/off, then they probably should not be a target. Biologics 101 and 102 are covered with just about the same slides at every dermatology meeting every week of the year!

Stupid is, as stupid does!

Even Vimal is smart enough to figure this out!

 

[anonymous]

You left off contamination of Halog topical steroid causing backorder. Even the contract manufacturers cannot get it straight! Good thing sales are down on Absorica, since the tropical storms probably took down the Puerto Rico capacity too.

Correct.
Just another indicator of Sun's 'cut the corner' approach to safety and quality.

It's a pervasive mindset - squeeze every rupee out of supplier partners.

#yougetwhatyoupayfor

 

[anonymous]

It's actually surprising that they're still in business.

Seriously, I wonder how long it will be before the chief Indian pulls the plug on his 2+billion US purchase.

Interestingly, Ranbaxy was so much like Sun is today ... just slimy.

 

[anonymous]

if you were a patient who was covered with Psoriasis all over your body and you had to go on an IL-23, which would it be? Gus, Tildra, or Risa?

See how can you sell this crap?

If I was a trainwreck type patient like the one listed above, I would give my patient Saliq IL-17 with the best efficacy data.