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Humalog Insulin generic

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Q: This one is for all the drug companies…Will there ever be a generic Humalog/Novolog insulin available?

A: Anita is correct, although you should know that technically speaking, insulin is treated by the FDA as a small molecule drug (not a biologic medicine). What this means is that while vaccines and most biologic drugs are governed under the Public Health Services Act, which would have to be amended to allow for generics, because insulin and Human Growth Hormone (HGH) were already on the market Hatch-Waxman was signed into law, the law considers them small-molecule “drugs” which are governed by the Federal Food, Drug & Cosmetic Act, therefore generics are legally permitted right now. Furthermore, the patents for Eli Lilly & Company’s Humulin insulin products expired in 2001, and Novo Nordisk’s Novolin insulin products expired in 2002, so patent protection for these pruducts is not at issue. But the major manufacturers still have a few years on the newer insulin analogs. For example, Lilly’s Humalog and Novo Nordisk’s Novolog rapid-acting insulin analogs have patent protection until 2014; I believe Lantus has patent protection until 2015, and Levemir has patents that run through 2017 before being challenged by biogenerics.

But as Anita noted, a major impediment has been the FDA’s refusal to outline procedures for manufacturing or how manufacturers could obtain approval. In August 2006, four state governors, looking to ease drug costs under state programs, petitioned the FDA to provide guidelines for generic versions of insulin and somatropin/human growth hormone (HGH). In their petition, the governors joined other critics in accusing the Agency of dragging its feet.

“The FDA’s delay in informing manufacturers of the requirements for obtaining approval of therapeutically equivalent versions of insulin and HGH has cost the states and other health-care providers hundreds of millions of dollars,” the petition said. Democratic Governors Kathleen Sebelius of Kansas and Jim Doyle of Wisconsin joined Republicans Tim Pawlenty of Minnesota and James Douglas of Vermont in signing the petition. Since then, the governors of New Mexico, Virginia and West Virginia have also signed the petition.

A spokesman named Brian McClung speaking on behalf of Minnesota Gov. Tim Pawlenty added that before generic insulin products could be released, the FDA must create manufacturing standards, which they have not done. “It’s been 22 years,” McClung said. “There is no scientific reason for the FDA not to do this, especially when American patients spend $1.5 billion a year on insulin.”

The FDA is slowly but surely being forced to move. In May 2006, the Sandoz unit of Novartis sued the FDA and won in a lawsuit on the FDA’s refusal to provide a decision on an application for generic human growth hormone known as Omnitrope. Omnitrope has been available since last year.

The FDA is also being forced by legislators. In February 2007, Senator Hillary Rodham Clinton, Senator Charles Schumer and Representative Henry Waxman introduced legislation (S. 623/H.R. 1038, the “Access to Life-Saving Medicine Act of 2007″) that would give the FDA the express legal authority to approve cheaper, generic versions of biotech drugs known as biologics or follow-on protein products, thus eliminating any excuses they now rely on for failure to move on the issue.

But whether generic insulins emerge is a complex subject that is impacted by regulatory inaction, political lobbying from major drug makers, and basic economics. I have written a complete article on this subject which you can read here:

http://www.diabetesthought.com/articles/generic-insulin.html

Hope the article proves enlightening!

Q: is there a generic brand for insulin?
like novalog or humalog or even lantus

A: Please see the web pages for more details on Insulin.

Q: Lantus or NPH? Humalog or R?
I have been on both Lantus and NPH…I am back on NPH now, which i realize is not the updated version of the long acting insulin, but it works for me. and when i took lantus i really didnt see much difference in the effects…just curious. i hate to feel like im “behind technology” with my diabetes, but when something works, why change it? also i take R insulin due to the fact that Humalog is so expensive, even with insurance paying some of it. i can get generic N and R insulin for less than $50…..whereas Humalin N and Humalog together cost me $160.

A: I really liked the NPH, it allowed Gina to cut back on the number of shots. The only reason we went back to lantus is because the peaks that accompany NPH were too much for her. They were making her crash.

You answered your own question… if it aint broke dont fix it! Everyone is unique with their lifestyle, their careers, and their blood sugars. NPH is a good choice, and it works for you. Humalog isn’t any better or worse than Novalog. It works the itty bittiest bit faster. It’s a better choice for us because Gina takes her fast acting insulin post-meals (five year olds aren’t the best at committing to what they’re going to eat).

Q: Diabetics…. or those of you who know about diabetes…?
Is there a generic brand for Humalog (the short acting Lilly insulin)?

A: The only thing close to it is novolog. thats the best i can do for you and its probably wrong.

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