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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Enbrel and Humira Prices Mysteriously Rise in Tandem. What Could be the Bizarre Reason?

Enbrel and Humira Prices Mysteriously Rise in Tandem. What Could be the Bizarre Reason? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In 1998, the drug company Amgen launched a transformative arthritis treatment called Enbrel. At the end of 2002, federal regulators approved a similar drug called Humira.

 

The drugs work in fundamentally the same way. They are approved for many of the same ailments. They have been hugely valuable to patients — and big drivers of profits for the two pharmaceutical companies that make them. Humira brought in $14 billion last year for AbbVie. Enbrel was the top moneymaker for Amgen, with $5.4 billion in revenue.

 

But the similarities don't end there. They've also undergone closely timed list price increases, nearly identical in magnitude, for more than a decade — more than tripling in price since they were launched.

 

Collusion is a serious charge that typically requires direct evidence, such as emails, meetings, or phone calls between executives showing they've agreed to fix prices. Though they are striking, drug price hikes in sync aren't by themselves evidence of collusion. Instead, they may reveal something fundamental and strange about how competition works in the drug industry.

Pharma Guy's insight:

These are not the only drugs whose prices have risen in tandem. Read "Sanofi & Novo Nordisk Raise Diabetes Drug Prices in 'Lockstep' With One Another"; http://sco.lt/7sltK5 

 

Bernie Sanders may have read that post. He wants the feds to investigate these drug companies for possible price collusion.

“We are concerned that the potential coordination by these [insulin] drugmakers . . . may indicate possible collusion, and we believe this egregious behavior warrants a thorough investigation,” the lawmakers wrote to Justice Department officials.

The three companies that make insulin have strongly denied that they have colluded and stressed that they set their prices independently.

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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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