Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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The Dog-Eat-Dog-Eat-Dog World of Biosimilars!

The Dog-Eat-Dog-Eat-Dog World of Biosimilars! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Amgen took one step closer to approval for its biosimilar of the world’s biggest-selling drug last night, but analysts don’t see it hitting the market this side of 2020 as a bitter patent battle continues.

 

The FDA advisory voted 26-0 that its version of AbbVie’s ($ABBV) Humira (adalimumab), currently known as ABP 501, should be approved along the same lines as the original drug--which includes licenses for rheumatoid arthritis and plaque psoriasis, as well as Crohn's disease and ulcerative colitis (UC).

 

Humira makes around $14 billion (with $8.4 billion made in the U.S.) a year and depending on how Amgen decides to price its copy (typically in Europe biosims are around 25% cheaper than the original), it could be set to eventually take a fair chunk of that away.

 

So, champagne corks popping at Amgen? Not quite, as even if, as expected, it gains full approval for all indications this year, it will likely not be launching its drug until 2022 if AbbVie has anything to do with it.

 

That’s because the two have locked horns in an increasingly bitter patent war, as AbbVie believes it has another 6 years of legal protection before anyone can release a biosimilar version. The dispute is still ongoing in the courts.

 

But in a reverse of fortune, Amgen is in fact today playing the role of AbbVie as the FDA panel turns its attentions to a biosimilar version of its blockbuster drug Enbrel (etanercept), which is indicated for rheumatoid arthritis and other chronic autoimmune conditions.

 

Novartis is seeking an approval for its Enbrel copy GP2015, which FDA staffers have already said in documents posted on the agency’s site this week is “highly similar” to its reference product, and the five licenses Enbrel has. The panel will meet today to discuss whether it too should recommend approval.

 

But guess what? In a familiar sounding scenario, Amgen is suing Novartis’ generic and biosimilar unit Sandoz on the grounds that its biosimilar infringes several of Enbrel's patents, so any launch could also be delayed.

 

And Amgen was in fact the first to succumb to biological copies in the U.S. when, just over a year ago, the FDA approved its first biosim in the form of Zarxio (filgrastim-sndz) from Sandoz--a biosimilar of Amgen's chemotherapy side effects drug Neupogen (filgrastim).

 

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Amgen's R&D Chief More Concerned About "Labeling" Than Patient Safety... Ugh!

Amgen's R&D Chief More Concerned About "Labeling" Than Patient Safety... Ugh! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A month ago, Amgen and AstraZeneca were confidently rolling up data from three highly touted late-stage studies on the psoriasis drug brodalumab for a new drug application that was widely viewed as a shoo-in at the FDA. But late Friday evening, as the industry was heading out for a long Memorial Day weekend, Amgen abruptly said it was pulling out of the long-running collaboration on the high-profile IL-17 program after evaluating the likely commercial impact it would face in light of the suicidal thoughts some patients reported during the studies.


"During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab," said Amgen R&D chief Sean Harper in a statement. AstraZeneca, which paid $50 million and shouldered the lion's share of the R&D costs to partner with Amgen three years ago, was left holding the damaged goods as it said separately that R&D execs would now think through what the future could hold for the drug.

Pharma Guy's insight:


Nice way to express your concern for patient safety, Sean! I suppose if Amgen did not have to mention suicidal thoughts that you'd be OK with it. Ugh!

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Et Tu, Amgen? Blincyto's Bling! Bling! Price Tag!

Et Tu, Amgen? Blincyto's Bling! Bling! Price Tag! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

FDA approved Amgen's Blincyto (blinatumomab) on December 3, 2014, as a second-line treatment for Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, which affects around 6,000 patients in the US.

The price tag of $178,000 per two-cycle course makes it one of the most costly drugs on the market.

This is just one of the record number of 15 "orphan" drugs approved by the FDA in 2014 (read "43% of New Drugs Approved by FDA in 2014 were for Treatment of Rare Diseases"). 

FDA considers Blincyto a "breakthrough" therapy, which means preliminary clinical evidence demonstrates the drug "may have substantial improvement on at least one clinically significant endpoint over available therapy."

On FDA Voice (FDA's blog), commissioner Margaret A. Hamburg said "Consider for example, Blincyto, approved just last week to treat Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia. CDER employed all of its expedited review programs to help get this drug to market as early as possible, five months ahead of its review goal date. The sponsor also benefited from incentives for drugs that treat rare diseases." 

Despite the extraordinarily high price of Blincyto, payers are not likely to complain about the price as much as they complained about the price of Sovaldi. Read on to learn why I believe that is true.

Pharma Guy's insight:


This is just one of the record number of 15 "orphan" drugs approved by the FDA in 2014 (read "43% of New Drugs Approved by FDA in 2014 were for Treatment of Rare Diseases"). 

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Amgen Wants to Own Your Protected Health Information in Exchange for Copay Card

Amgen Wants to Own Your Protected Health Information in Exchange for Copay Card | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Amgen is the Rumpelstiltskin of the drug industry.

As reported by MedPage Today/CardioBrief, "Doctors, pharmacists, patients and others are now starting to learn that in order to receive financial assistance from Amgen for its expensive new cholesterol drug Repatha, patients are being required to surrender rights to their personal information, including their personal health information."

Not even HIPAA-protected health information is off limits.

"The agreement specifically states that by agreeing to the terms [of Amgen's privacy policy] patients may lose federal HIPAA protection," notes CardioBrief.

Patients must agree that they "understand that Amgen may use [their] personal information, including [their] personal health information, for 10 years once [they] accept this Authorization ..." 

What other nasty things must poor people agree to in order to get a copay card?


Find out here.

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Calif Newspaper CEO Calls Gilead a "Good Pirate" that Knows Certain Captives are Worth More. What About Amgen?

Calif Newspaper CEO Calls Gilead a "Good Pirate" that Knows Certain Captives are Worth More. What About Amgen? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

"Pharmaceutical company pirates hold Californians hostage," says Jeff vonKaenel is the president, CEO and majority owner of the News & Review newspapers in Sacramento, Chico and Reno.


Perhaps Gilead spent so much time and money researching and developing this wonder drug that they deserve a fair return on their investment? Well, no. Gilead did not create the drug. Another company, Pharmasset, developed Sovaldi.


After Pharmasset conducted successful clinical trials for treating hepatitis C in 2011, their stock price soared, tripling in value. Then in November 2011, Gilead bought them for $11 billion, 89 percent higher than the stock price.


Why did Gilead pay such a premium for Pharmasset? Perhaps they wanted the right to jack up the price of the wonder drug. Pharmasset had planned to charge only $36,000 for a course of the drug. But Gilead saw the huge profit potential. And, as any good pirate knows, one should not have the same ransom price for each captive. Certain captives are worth more.


So while Gilead charges Americans $84,000, they charge the Germans $66,000 and the English $57,000. And they charge the Egyptians only $900 for a supply of the drug. While this ransom pricing has been good for Gilead stockholders, who have seen their stock rise from $20 in October 2011 to $102 last week, it has not been so good for the millions of people who are waiting to be cured of hepatitis C. Only a small percentage of the world’s population who would benefit from the drug can now afford to pay for it.


Ransom pricing instead of reasonable pricing means that many people will die needlessly. And millions will suffer. We should say “no” to the Big Pharma pirates and empower our government to regulate the pharmaceutical companies so that we can get similar prices and access to drug treatment that people in other countries do.

Pharma Guy's insight:


LOL! But vonKaenel should also take a look at another Calfornia drug company: Amgen, which sells Blincyto (blinatumomab) for  $178,000 per two-cycle course, making it one of the most costly drugs on the market. For more on that, read Et Tu, Amgen? Blincyto's Bling! Bling! Price Tag!

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