stupidity is paved in smoots?

You don't have to belong to ISIS to know that decreasing the levels of TNF in those with autoimmune diseases is a great form of torture primarily designed to extract money based on those who place undue faith in mortals with degrees after their name. Use your ability to read, write, observe and evaluate work such as that of Dr Denise L Faustman.

Death is generic.


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Cell Mol Life Sci. 2005 Aug;62(16):1850-62.
The therapeutic potential of tumor necrosis factor for autoimmune disease: a mechanistically based hypothesis.
Kodama S1, Davis M, Faustman DL.
Author information
Abstract

Excess levels of tumor necrosis factor-alpha (TNF-alpha) have been associated with certain autoimmune diseases. Under the rationale that elevated TNF-alpha levels are deleterious, several anti-TNF-alpha therapies are now available to block the action of TNF-alpha in patients with autoimmune diseases with a chronic inflammatory component to the destructive process. TNF-alpha antagonists have provided clinical benefit to many patients, but their use also is accompanied by new or aggravated forms of autoimmunity. Here we propose a mechanistically based hypothesis for the adverse events observed with TNF-alpha antagonists, and argue for the opposite therapeutic strategy: to boost or restore TNF-alpha activity as a treatment for some forms of autoimmunity. Activation defects in the transcription factor nuclear factor kappaB leave autoreactive T cells sensitive to TNF-alpha-induced apoptosis. Treatment with TNF-alpha, by destroying autoreactive T cells, appears to be a highly targeted strategy to interrupt the pathogenesis of type 1 diabetes, lupus and certain forms of autoimmunity.

PMID:
    15968469
    [PubMed - indexed for MEDLINE]





Business
Generic Copies of Remicade Go on Sale in Europe
Latest move marks milestone for cheaper versions of complex biotech drugs
Hospira began selling its biosimilar version of anti-inflammatory drug Remicade in the U.K. and Belgium on Wednesday, and last week it launched in 10 other European countries including Germany and France. ENLARGE
Hospira began selling its biosimilar version of anti-inflammatory drug Remicade in the U.K. and Belgium on Wednesday, and last week it launched in 10 other European countries including Germany and France. Photo: Getty Images
By
Peter Loftus
Feb. 25, 2015 5:47 p.m. ET
0 COMMENTS

Generic-drug makers have begun selling lower-priced copies of the blockbuster anti-inflammatory drug Remicade throughout Europe in recent days, a milestone in the emerging market for so-called “biosimilars,” or generic versions of complex biotechnology drugs.

An approaching wave of biosimilars in Europe and the U.S. could help contain drug spending, while eroding sales of expensive branded drugs such as Remicade, which is marketed by Merck & Co. and Johnson & Johnson . Remicade had global sales of $9 billion last year, making it one of the top-selling drugs in the world.

Hospira Inc., of Lake Forest, Ill., began selling its biosimilar version of Remicade in the U.K. and Belgium on Wednesday following patent expirations in those countries, and last week launched in 10 other European countries including Germany and France, a spokeswoman said.
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Hospira’s product, Inflectra, will be priced at about 20% to 30% below the price for branded Remicade, the spokeswoman said. Prices for Remicade vary by country and use. In the U.K., the drug costs about £420, or $650, per vial, which translates into £5,035, or $7,816, for a starting round of therapy for an average patient with ulcerative colitis, according to the U.K. National Institute for Health and Care Excellence.

South Korea’s Celltrion Healthcare announced Tuesday it began selling a biosimilar version of Remicade, which it calls Remsima, in 12 European countries including the U.K., France and Germany.
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Remicade was one of the earliest of a complex category of biotechnology drugs when it was introduced in 1998, and is now approved to treat a range of conditions including rheumatoid arthritis and gastrointestinal disorders. The drug is infused intravenously.

Hospira began selling its biosimilar of Remicade in smaller markets in eastern and central Europe in 2013 and 2014, after patent expirations there. The European Commission approved Remsima and Inflectra for sale in 2013. They both contain the same active ingredient as Remicade, which is also known by the generic name infliximab, and clinical studies showed their safety, efficacy and quality to be comparable to Remicade’s, according to the European Medicines Agency.

Merck, which markets Remicade in Europe, reported a 10% decline in fourth-quarter Remicade sales due to the availability of biosimilars in some of the smaller European countries. The company has cautioned that the wave of patent expirations for Remicade this month in bigger European countries would trigger a more substantial decline in sales of the brand.

“While we believe we will retain many current patients being treated with Remicade, we will face increased competition for new patients and there will be mandatory price reductions in certain markets,” a Merck spokeswoman said Wednesday.

Plans are proceeding to bring biosimilar versions of Remicade to the U.S. Celltrion last year applied for Food and Drug Administration approval to market Remsima, which Hospira would market in a partnership deal between the companies; an FDA decision is pending. An FDA advisory committee had been scheduled to meet March 17 to review the proposed product, but the FDA said Wednesday it was postponing the meeting because it had requested more information from Celltrion.

The U.S. Patent and Trademark Office this month rejected the validity of a Remicade patent due to expire in 2018, which could clear the way for a biosimilar to enter the market before then. J&J, which markets Remicade in the U.S., said in a news release it believes the patent is valid and will pursue appeals of the decision.

Write to Peter Loftus at peter.loftus@wsj.com