Posted on 10/16/2014 12:32:32 PM PDT by Kaslin
Buried inside of the 20,000 pages of the Obamacare monstrosity are a few paragraphs which could create a multi-billion dollar industry in the American healthcare sector. Known as "biosimilars," the law allowed for the production of complex drugs which are medically equivalent versions of biologics (drugs derived from living organisms), and can treat deadly diseases ranging from Alzheimer's, AIDS, and rheumatoid arthritis.
Not only can biosimilars save lives, the competition they create for a heavily regulated and patented marketplace can help patients by lowering the price of their prescriptions by up to 40 percent. The average annual cost of biologic drugs is roughly $35,000, so any savings can often make the difference between life and death. That is why the creation of approval process for biosimilars may be the only part of Obamacare that enjoys bipartisan support.
However, as Obamacare's burdensome mandates are already making your insurance premiums skyrocket and the IRS is ready to issue fines for not having coverage, any plans to save patients' money is an important development. But, ironically, it’s President Barack Obama's own federal bureaucrats who may be standing in the way.
Now, it is up to the Food and Drug Administration (FDA) to implement the biosimilar approval process. But millions of dollars have been spent on a lobbying effort from Obama's crony capitalist friends on K Street to protect the interests of biologic drug markers. Initially, they were given a 12-year data exclusivity clause in the Obamacare law. But now, they are fighting through a questionable grassroots campaign, with the goal of distracting the FDA.
These special interests are demanding unnecessary distinct naming rules for the ingredients in generic drugs, even though Obamacare does not allow for it. Americans with life- threatening diseases do not deserve to suffer thanks to these complicated and underhanded tricks by those in the pockets of Big Pharma.
America needs to allow for biosimilars to enter into this already enormous global marketplace. If America does not promote an environment that supports research and developments of these new treatments, other countries will pick up the slack. Countries like Brazil and South Korea are already recognized as leaders in this area, while America does not have a single biosimilar available to patients. And less expensive biosimilars have been available throughout Europe for nearly a decade.
For example, in a recent broadcast of PBS "NewsHour," viewers met Phil DeLuca, who is 71 and was told by doctors that his bone marrow was not producing enough normal red blood cells. He was prescribed a biologic drug to save his life, which had an $800 per-month copay under his insurance plan. But if he lived in Europe, there are more than five versions of that drug available in biosimilar form. These options would have saved him thousands of dollars per year.
As drugs become more sophisticated, biologic drugs are expected to account for 75% for all U.S. drug spending by 2020. To save money and encourage additional innovation, the government-created monopoly for biologics must be stopped.
It is time for Obama's FDA to complete the pathway for biosimilars and bring them to market. Innovative life-saving treatments are too important to be in the hands of well-funded lobbyists, bureaucrats, and special interests.
What a clueless article.
There is already a biosimilar on the market in the US, Teva’s Granix, which is a biosimilar of Neupogen, although it was approved through the regular 351(a) pathway.
There are two other products in registration in the 351(k) biosimilar pathway. This means that they are less than 8 months from approval.
I know it's not a perfect answer, but if he spends $800 on a plane ticket to England, gets a concierge doctor, it sounds like he could save a lot and get a european vacation out of it.
Thanks for posting this.
I have been familiar with this part of the bill, which really had nothing to do with Obamacare or anything, but was included along with all sorts of other stuff.
I say this to pointout that this Biosimilar legislation was and is actually good and sensible. Good for business, good for consumers.
I will read this article to see what thenauthor is saying and appreciate your posting it.
You know what you are talking about.
I will say, though, that this:
“There is already a biosimilar on the market in the US, Teva’s Granix, which is a biosimilar of Neupogen, although it was approved through the regular 351(a) pathway.”
Really means it is not a Biosimilar.
I don’t know if there ever will be one, at least not in the near future.
So, I am curious as to the two drugs in the pipeline you mention.
This article makes little sense.
But worse than that is it is bereft of factual content.
Therapeutic Proteins International (Chicago, IL) is expecting 351(k) approvals shortly and Sandoz/Momenta are also already well on their way in the biosimilars space.
The "Purple Book" has recently been made available by the Agency to publish a list of biologics and their patent and exclusivity expiration dating, similar to the "Orange Book" which is published for drug products, and utilized for reference routinely by generic drug manufacturers.
FReegards!
Thanks.
Novartis has the pockets to do this.
Amgen has a Humira biosimilar that just completed a P3 trial for psoriasis, and Sandoz has a filgrastim biosimilar in registration (approval is imminent).
Teva’s product is a biosimilar, although the company filed through another pathway.
The regulatory pathway determines the data required to file a valid application. It is not an indication of the classification of the biologic therapy per se.
There are biologics on the market in the US, such as menotropins (LH/FSH), somatropin (growth hormone), human insulin and human insulin analogues, fully-synthetic coagulation factor products, etc. that were filed through the 351(a) BLA pathway. This means that the clinical trials needed to generate data that treats the product as a new molecular entity, although the therapy is an exact copy of a naturally occurring molecule.
A handful of biologics were filed and approved through the 505(b)(2) pathway that allows existing clinical data to be used in the New Drug Application. Examples of these are glucagon and follistim. Again, these are naturally occurring molecules that are being manufactured through an entirely synthetic biologic process.
Also, there are generic biologic competitors to Lovenox on the market. This is a platelet antibody used with CHF patients. These products were approved through the generic (ANDA or SNDA) approval pathway.
What PPACA does is mandate that FDA create a single pathway for approval of all biosimilars.
I expect Amneal and Sandoz to both get approval through 351(k) for their filgrastim biosimilars.
There’s intense pressure on the FDA on this. In case you are not aware, filgrastim is used extensively in chronic kidney disease patients. The End-Stage Renal Disease (ESRD) Program is a single-payer system that is part of Medicare. It’s a socialistic POS signed into law by good old Richard M. Nixon.
Cost of the ESRD program has been growing faster than the Medicare average for several years...
http://www.usrds.org/2013/pdf/v2_ch11_13.pdf
Great stuff. I appreciate it.
I have never heard of GCSF used t treat kidney disease. Epo, of course.
I do think the definition of what a Biosimilar is is still not pinned down.
My interest in this law has been in the innovator drug exclusivity.
It sounds like to me that if someone doesn’t go to the expense of developing a new drug in the first place, there will be no biosimilar drugs to copy from. The original that cost drastically more to initially produce and get through the regulatory process.
So yes, you can make existing drugs cheaper but at the same time there will be fewer new drugs for other ailments that people suffer from.
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