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.
Curated by Pharma Guy
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AbbVie is 3rd Pharma Company to Vow to Keep Drug Price Increases Below 10% - for 2017 At Least!

AbbVie is 3rd Pharma Company to Vow to Keep Drug Price Increases Below 10% - for 2017 At Least! | Pharmaguy's Insights Into Drug Industry News |

AbbVie Inc Chief Executive Richard Gonzalez on Wednesday promised to keep all drug price increases in 2017 under 10 percent, becoming the third global drugmaker to publicly make that pledge.


Speaking at the annual JP Morgan Healthcare Conference in San Francisco, Gonzalez said his company would raise prices just once this year, and the percentage increases would not exceed single digits.


AbbVie, whose rheumatoid arthritis treatment Humira is the world's biggest-selling drug, joins Allergan and Danish diabetes company Novo Nordisk as the first major drugmakers promising such a limit on price increases.


"There's a strong debate going on right now about pricing," Gonzalez told investors. "We need to make sure we are operating in an appropriate way ... and demonstrating the value of the products that we have."


Further Reading:

  • “Enbrel and Humira Prices Mysteriously Rise in Tandem. What Could be the Bizarre Reason?”;
  • “Abbie on a Humira TV Ad Spending Spree in Anticipation of Biosimilar Competition”;
  • “Novo Nordisk President Pledges to Limit List Prices of Drugs But Cannot Guarantee Market Price”;
  • “Allergan's Brent Saunders' "Manifesto" on Drug Prices & Access”;
Pharma Guy's insight:

What about 2018, 2019, 2020? I guess the pledge lasts only as long as the public maintains the heat!

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Fastest Selling Drugs in First Half of 2016

Fastest Selling Drugs in First Half of 2016 | Pharmaguy's Insights Into Drug Industry News |

Recently-published second-quarter results provide an opportunity to assess which pharmaceutical products have grown the most during the first half of 2016 versus the same period last year.

Sales of Bristol-Myers Squibb's PD-1 inhibitor Opdivo lead the way, with global revenues of $1.5 billion generated during the first six months of 2016 versus sales of just $162 million in the comparative period of 2015.

Opdivo is approved across a number of oncology indications, with performance in the second-line non-small-cell lung cancer (NSCLC) market integral to its impressive launch. Revenue growth over the next six to 12 months will be watched with great interest, however, following Opdivo's recent failure to demonstrate a survival benefit in first-line patients; an indication where Merck & Co.'s rival drug Keytruda is now expected to assume first-to-market status.

Pharma Guy's insight:

Compare this to Thomson Reuters' Drugs to Watch report; 

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Abbie on a Humira TV Ad Spending Spree in Anticipation of Biosimilar Competition

Abbie on a Humira TV Ad Spending Spree in Anticipation of Biosimilar Competition | Pharmaguy's Insights Into Drug Industry News |

Amid projections and prognostications of overall pharma ad spending increases for 2016,’s ad tracking numbers for May bear that out, with AbbVie’s ($ABBV) Humira leading the charge. AbbVie spent more than $25 million on Humira TV ads in May, bringing the drug’s TV spending total to $118 million for the year. That means AbbVie has already topped its full-year 2015 TV ad spending of $98.6 million.

Humira has been running nine ads since January, spread thematically across its three FDA-approved indications for arthritis, psoriasis, and ulcerative colitis and Crohn’s disease, with the most, a total of $60.9 million, spent on placing its 5 TV ads for arthritis, according to data.

The TV spend reflects Humira’s importance to AbbVie; it brought in $8.4 billion in sales last year and accounted for 62% of the company’s total revenue. Humira revenue for the first quarter of 2016 was $2.2 billion. The Wall Street Journal recently reported that AbbVie raised the price of Humira 8 times in the past three years, increasing its price 73% to about $49,000 a year before discounts.

Pending competition for Humira may also be spurring TV advertising, with AbbVie estimating its first biologic competitors coming to market in Europe in 2018.

Pharma Guy's insight:

2016 is shaping up to be even a better banner year for DTC than 2015! For updated 2015 spending numbers, read  “Pharma Drug Ads: A Glass Half Empty is a Glass Half Full”; 


Also read: “Big Pharma Spending on TV Ads Like a Drunken Sailor”;

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We are one step closer to a new generation of cheaper drugs

We are one step closer to a new generation of cheaper drugs | Pharmaguy's Insights Into Drug Industry News |
And Obamacare paved the way.

With the high cost of specialty drugs capturing so many headlines these days, here's a bit of a change of pace: A new wave of cheaper drugs marked a major milestone Thursday.

The Food and Drug and Administration for the first time has accepted an application for a copycat version of what's known as a biologic, which is a complex drug made from proteins of living organisms. These biologics are cutting-edge therapies that can be more effective than regular drugs made from chemicals — and, not surprisingly, they also can be expensive. For example, some biologics to combat rheumatoid arthritis, a disease affecting about 1 percent of the adult population, can cost more than $5,000 a week.

While cheaper generics now dominate the U.S. market for traditional drugs, accounting for about 85 percent of all prescriptions, you still can't get another version of biologic drugs in this country. That's about to change, though, because of a provision included in the Affordable Care Act that provides a pathway for copycat biologics, known as biosimilars, to enter the U.S. market.

The biosimilars' potential for savings in the United States seems to be pretty huge. The pharmacy benefits manager Express Scripts, which has actively advocated for more rapid adoption of biosimilars, estimates that the United States would save $250 billion in health-care spending over the next decade if just 11 biologics had biosimilar alternatives.

Thursday's FDA application from Sandoz is just the first step. The company, which already markets its biosimilar in 40 countries, could gain final FDA approval as early as the first quarter of 2015, according to the Avalare Health consulting firm. With so much concern from health-care payers over a projected rise in U.S. drug spending in the next few years, the development of domestic biosimilar market is something worth watching

Pharma Guy's insight:

Sandoz is the generics division of Novartis. Other pharma companies are fighting tooth and nail to keep biosimilars off the market in the U.S.:..

... such as Abbott's April 2, 2012 citizen's petition against FDA approval of biosimilars (read more about that and find a copy of the petition here: "Abbott Labs Petitions FDA to Disallow Biosimilars"). 

"If the challenge succeeds," says WSJ, "less-expensive versions of complex biologic drugs couldn't go on sale in the U.S. for years, and consumers may never have access to facsimiles of existing treatments such as Abbott's rheumatoid arthritis therapy Humira, which had $3.4 billion in U.S. sales last year and is projected to be the world's No. 1-selling drug this year."

NOTE: Humira topped the list of most advertised brands in 2013. See 

The Top 20 DTC Ad Spenders in 2013 Virtually Ignored Digital
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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 |

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"; 


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 |

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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AbbVie Has Room to Cut Its $203 Million Humira Ad Budget, Say Analysts. But Why Bother?

AbbVie Has Room to Cut Its $203 Million Humira Ad Budget, Say Analysts. But Why Bother? | Pharmaguy's Insights Into Drug Industry News |

With biosimilars makers eager to grab a piece ofHumira's $12.5 billion-plus revenue, copies of AbbVie's ($ABBV) blockbuster are on their way. What analysts disagree on, though, is when they'll arrive and how long it'll take them to make their presence known--and a pair of UBS analysts, for one, thinks the Illinois pharma has some marketing maneuvers up its sleeve to minimize their impact.

According to UBS analysts Marc Goodman and Ami Fadia, should the entry of Humira biosimilars put branded sales on a serious downswing, AbbVie has some room to pare down costs. Right now, it ranks as the No. 2 ad spender in Big Pharma, and last year it shelled out 56% of its budget--$203.2 million--on advertising the drug.

Pharma Guy's insight:

File this one under "You don't need an analyst to know which way the wind is blowing." But I guess $200 Million is not a lot considering Humira sales are about $8 BILLION annually. Thus, the marketing budget is less than 3% of sales! Even if Humira lost 50% market share, which often happens when generics hit the market, AbbVie can still spend $200 Million on adverting and that would be just 5% of sales!

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