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Profits at center of biosimilars debate

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Profits are at stake on all sides of a fierce Indiana Statehouse fight over a bill that would regulate the dispensing of generic biotech drugs.

House Bill 1315, which is scheduled for a Senate floor hearing on Monday, would require pharmacists to check with a patient’s physician before automatically substituting a generic version of a biotech drug for a brand-name version.

This kind of substitution happens all the time now with chemical drugs, such as the brand-name cholesterol drug Lipitor and its generic version atorvastatin.

One reason it does is that the makers of generic drugs and the health insurers that pay most of the bill for prescription medicines make sure pharmacists benefit financially for doing so.

Generic drugmakers would rather pay higher profits to pharmacies than run their own sales and marketing efforts to convince pharmacists to dispense generics. And health insurers, such as Indianapolis-based WellPoint Inc., have strongly encouraged generic substitution as a way to reduce their own spending on medical claims. Current biotech drugs, such as the cancer drug Avastin, can cost tens or even hundreds of thousands of dollars for each patient per year.

The profit margins for retail pharmacists on atorvastatin, for example, are more than double what they are for branded Lipitor, according to an analysis by Philadelphia-based Pembroke Consulting.

Also, large distributors of drugs, such as Cardinal Health and McKesson Corp., make profit margins of 18 percent on generic drugs, compared with margins of just 2 percent on brand-name drugs, according to Pembroke.

The only problem for pharmacies is that the fat margins on generic drugs diminish over time. So with overall spending on prescription medicines declining in 2012 for the first time in history, drugstores are relying on a steady stream of patent expirations on brand-name drugs to keep their bottom lines healthy.

But the wave of blockbuster patent expirations will end in 2016, and after that, pharmacies need a new batch of drugs going generic. The obvious source for that new batch is the world of biotech, or specialty drugs, where several drugs' patents have already expired—but the drugs have faced no competition from generics.

The health reform law of 2010 included the first regulatory pathway to allow generic versions of biotech drugs, although the rules are still being hammered out by the U.S. Food and Drug Administration.

“Drugstores must either embrace the low-cost generic revolution or figure out how to penetrate the specialty market. Otherwise, they'll find it hard to climb out of the rabbit hole,” wrote Adam Fein, president of Pembroke Consulting, in a March 7 blog post.

But makers of brand-name drugs, such as Indianapolis-based Eli Lilly and Co., would benefit greatly if generic biotech medicines cannot immediately steal away sales once the patents on their brand-name drugs expire.

For example, U.S. sales of Lilly’s antipsychotic drug Zyprexa plummeted 88 percent in the 12 months after the drug’s U.S. patent expired in October 2011.

By contrast, Lilly’s biotech insulin Humulin has continued to rack up annual sales of more than $1.2 billion, even though its patent expired in 2000.

Currently, biotech drugs account for only one-quarter of all U.S. sales of brand-name drugs, according to data from IMS Health, a Connecticut-based market research firm. But nearly all large pharma companies, including Lilly, have staked their futures on using biotechnology to reverse a drought of new breakthroughs.

Last year, Lilly garnered more than $5 billion in sales from biotech drugs, or about one-quarter of all its drug sales. Of the 13 drugs Lilly has in Phase 3 clinical trials, eight of them are biotech drugs.

Lilly has thrown its support behind HB 1315, which was authored by Rep. Ed Clere, R-New Albany, at the request of biotech drug pioneer Genentech Inc., which is now a subsidiary of Switzerland-based Roche Group.

The stated concern of the drug companies is that, because biotech drugs are so much more complex than traditional chemical drugs, they will not be interchangeable like chemical drugs are. In industry parlance, biotech drugs are called biologics and their generic versions are called biosimilars, because they cannot be exactly the same as the original.

Clere told The New York Times in January that his bill “doesn’t do anything to prevent or discourage the use of biosimilars.”
 

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  • Zyprexa legacy
    Eli Lilly did make $69 billion on Zyprexa (Olanzapine) and they still expect to capture 20% of the US market as well as a billion year on ZyprexaXR. The patent only expires in the US and some Euro,Lilly announced they have an *authorized* distributor of generic Zyprexa. I am keenly interested in how they resolve remaining Zyprexa litigation. PTSD treatment for Veterans found ineffective. Zyprexa can cause diabetes. I took Zyprexa Olanzapine a powerful Lilly schizophrenic drug for 4 years it was prescribed to me off-label for post traumatic stress disorder was ineffective costly and gave me diabetes. -- Daniel Haszard

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  1. liek the rest of America

  2. These quaint,obsessed musings by the stalkers are certainly entertaining, but I'm trying to figure out what, if anything, all the yelping below has to do with Zak Brown.

  3. It's evident that Moffett was pushing the right buttons and corporate America is now trying to squash him. He just wanted to withdraw the free pilot services provided to the company by the pilots to try and put some pressure on a company that has not been interested in negotiating a contract in over 5 years. The company does not provide a contract because not having one has saved them a bundle of money. Shame on any Republic pilots not standing behind their union leader just because things are getting tough, can you not see such strategic moves by the company as putting the last union president in a corporate position and into THEIR pocket. Do you really believe the last union president is so appalled at the attempts by Moffett, do you not remember his oppositions to the company? We stood behind him. It has been proven over and over again for thousands of years without fail, a man cannot serve two masters. Anyone that believes people vote contrary to their paycheck and livelihood deserve to be taken advantage of, the recent statements by the former union president are laughable as he denounces the current union president from his new corporate position. Have you ever seen a drafted sports player score points for his previous team, it cannot be done, he is not on the pilots side anymore, he gets his money a different way now than you and I do, and he should not be allowed to remain on the seniority list. A drafted player brings strength, credibility, tactical knowledge, and a strategic advantage to his NEW team, he would not be drafted or paid were it otherwise. We are all forced to choose only one side to play for and support, not doing so has many references in life such as insider trading and shaving points, all illegal for good reason. This basic fact is why corporate moguls, scientist, and engineers all sign non-discloser agreements and non-compete clauses, as protection in case they are lured into switching sides as our former union president has done. No NFL coach ever drafted a player so that both teams could benefit and better understand each other, they are recruited to win the game against that former team, period. Likewise the company does not recruit the former union president by accident or mutual understanding, its strategy. Don't confuse playing the game with good sportsman-like conduct in support of common business and prosperity goals, with the requirement to only play for one side. Good men we all love and favor fall subject to this manipulation, often without their knowledge, and it is not a betrayal of their friendship to oppose them when they switch sides. If we did not love and trust them, they would not have been chosen and lured to the other side in the first place. The deception by the drafted player is not made at a conscious level, it's just human nature and it's all about money and power which corrupts our ability to be objective and loyal to two masters. This is why our court system created the defense attorney, and why our military created counter intelligence. Its strategy and its propaganda, and it works, and that's why the "powers to be" manipulate the chess pieces by sometimes changing their colors. Some players know they are being manipulated when their color is changed, but it brings them more money and power so they do not care. The rest have good intentions but do not even realize they are being manipulated. This tactic is also known by another name, Divide and Conquer. In battle sending an imperfect message with an imperfect team is obviously not ideal, but it's still being sent by YOUR team, your union leader, a leader that has common goals and common rewards with you, they are the best, because we have elected them to do a job for us. If you are not backing Moffett but believing the spin by those that have recently switched sides, you are taking food out of your own mouth. Showing unity and backing an imperfect situation still results in taking just as much ground, it's about unity and bargaining power. It's not necessary to wait around for that perfect attack because it will never come, the company will spin and attempt to destroy anyone that gets in their way. Ultimately it's not about any specific attack anyway, ASAP or whatever it makes no difference, it is and always has been only about power. If this company cared about safety it would not build pairings with 8 hour overnights, come on, are you that naive? Besides, do you really think Hoffa cares, no, he got a call from corporate America and was squeezed into denouncing Moffett. If he didn't they would spin the safety card against him and the Teamsters National with implication for truckers, future contracts, insurance rates etc...saying something like the Teamsters use safety as a bargaining chip, blah blah blah... Do you really think any pilot is going to do something unsafe for the contract, absolutely not, the only ones threatening safety here is the company with reduced rest, fatigue, and poverty. Do you not find it odd that Hoffa and the Teamsters are opposing a Teamster president publicly? Would the Teamsters National not normally support and work with one of their own? Why did they not sit down and help him strategize, correct any mistakes, and charge ahead? Would the Teamsters National not normally support and leverage a contract for all those pilots that have been paying Teamster dues, isn't that why we have all been paying Teamster dues in the first place? I sure haven't been paying dues so that the Teamsters National could come along and write this kind of an article undercutting our union leader and our unity. Whose side is the Teamsters National really on, it's obviously not the Republic pilots side.

  4. No matter what Moffatt does the company is going to spin it like he is the terrorist and brainwash people like you into believing it, wake up, back your players that are trying to change things for you and your livelihood. Where has Hoffa been for the last 6 years, except collecting our dues. Seriously, do you really think an FO going for upgrade, signed off by a checkairman ready for the upgrade, who then fails, is not even capable of returning as a First Officer.

  5. whoa!

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