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Old 04-16-2015, 03:57 PM
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Default APPROVED: Generic version of Copaxone gets go-ahead from FDA

Such great news! FDA Press Release and NYT link below. - Dave

FDA approves first generic Copaxone to treat multiple sclerosis

For Immediate Release
April 16, 2015

The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).

Sandoz has received FDA approval to market generic glatiramer acetate in a 20 mg/1 ml daily injection.

“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.”

The FDA applies the same rigorous and reliable standards to evaluate all generic drug products. As needed, the agency requires appropriate information to demonstrate sameness for complex active ingredients, such as glatiramer acetate. For this approval, FDA scientists established a thorough scientific approach for demonstrating active ingredient sameness that takes into consideration the complexity of glatiramer acetate.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline in function and increased disability. MS patients often experience muscle weakness and difficulty with coordination and balance. Most people experience their first symptoms of MS between the ages of 20 and 40.

In the clinical trials for Copaxone, the most common adverse reactions reported by those taking Copaxone were skin problems at the injection site (redness, pain, swelling and itching), flushing (vasodilation), rash, shortness of breath and chest pain.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

New York Times:
http://www.nytimes.com/2015/04/17/bu...temail0=y&_r=0
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Old 04-16-2015, 05:23 PM
Suebee Suebee is offline
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Yes, I'm all for lowering drug prices and making copaxone more assessible! My copays are greater than $100 month and expense to insurer is greater than $50000 annually. If I didn't have the insurance that I do , I could not use it. But I have some real concerns. Copaxone is a sophisticated injectable and the FDA 's process of approving generics has been under scrutiny. Here is excerpt from article from Forbes which can summarize better than me:
[copaxone is most ] complex than any drug of this type, where FDA has been asked to review copies. When it comes to these drugs, looking at bioequivalence data alone can be insufficient to tell how the drug will behave once it’s administered to the patient....
Copaxone is an especially hard case, because the drug’s benefits are thought to turn on the complexity of the mixture, which isn’t well understood.
The drug exits as a complex mix of long and short chains of polypeptides. It is believed that the precise proportion of these long and short chains in the solution is tied to the drug’s therapeutic attributes. But making sure that a copy batch of the drug can reproduce the same quantity of long and short chain carbohydrates, in the same proportion, isn’t straightforward. And the generic drug law effectively bars FDA from looking at evidence from human studies to see if the copy is working as well as the brand-name alternative. For the most part, all FDA can do is examine data comparing the two solutions, and how they get into the blood (bioequivalence data). But FDA can’t look at how the generic version affects outcomes in patients."
I am interested to know data behind
FDA's decision and how it is tolerated by patients.
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Old 04-16-2015, 05:25 PM
Suebee Suebee is offline
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http://www.forbes.com/sites/scottgot...approval-woes/

I'm glad that we are moving in right direction to make MS DMD more assessable. I just hope it is bio equivalent.
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Old 04-16-2015, 08:53 PM
celia celia is offline
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Polypeptides are proteins, not carbohydrates.
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Old 04-17-2015, 07:14 AM
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I was concerned also but I think the FDA is taking a very detailed approach to approving these biosimilar products:https://www.google.com/url?sa=t&sour...WO5CiB-yVJ40Ig
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Old 04-18-2015, 08:46 AM
Suebee Suebee is offline
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CVfactor, thanks for link. As you may have guessed from my last post, I am afraid of changes that may be made to the DMD I'm currently using with good results. My aggressive MS attack derailed my chosen career and altered my life forever. I've adjusted and moving forward in remission. I've reached a level of strength and normalcy I haven't had in almost 10 yrRs and hoping to reenter workforce soon, which is exciting. Because of several publicized FDA fails, I have some trepidation about generic copaxone being approved, but the paper you linked allays some fears and I'll take a chill pill.
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Old 04-21-2015, 01:06 PM
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Thanks Celia for that clarification. The cost savings should be substantial and is hugely welcome. The one downside to generic Copaxone is the shot frequency, which is the main reason why TEVA is trying to switch everyone over. But from personal experience, I found it easier to do a daily shot than one a few times a week. I liked the routine, which meant I never dread shot days, because, well, they were every day!
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Old 04-23-2015, 10:50 AM
Cvfactor Cvfactor is offline
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Default 40mg Generic

It looks like Momenta is pursuing a 40mg generic also:

http://www.momentapharma.com/pipeline/pipeline.php

I guess it would be easy to make a 40mg formulation if you already make a 20mg version. It seems the FDA has given a preliminary approval of this.

The only way this would work though is if Teva licensed the 40mg formulation to Momenta since they have a patent for it. This appears to be the case, but I wonder why Teva is doing this?
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Old 04-26-2015, 11:30 AM
Suebee Suebee is offline
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CVFactor, I think Momentum is doing a lot of legal posturing. The WSJ and other financial rags are reporting that momentum asserts that because the 40 mg/mL formulation of generic Copaxone contains the same substance as the 20 mg/mL formulation, momentum argues the FDA review process for both formulations should be completed within the same time frame. This makes me think that Momentum seems to be intending to do some legal wrangling to invalidate Teva's 40mg "long acting" copaxone's patent which doesn't expire until 2030. But Teva is fighting hard to show that the copaxone generic isn't bio equivalent by filing petitions, arguing among other things, that copaxone downregulates IL18 (which affects T-helper cell differentiation) significantly better than generic version. Obviously, a lot if money is at stake for lots of different players. It seems time is needed to straighten out legal issues and whether the formulations are indeed bio equivalent. Suebee
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Old 07-23-2015, 03:25 PM
Suebee Suebee is offline
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Hello all. I recently met with my neuro and discussed generic copaxone. In case you haven't been following the pharmaceutical rags, it's my understanding that by this September, it anticipated that supply of generic copaxone will be fully available to market and insurers will start pushing generic version. Some MS blogs are already showing posts about being stitched over. I am in remission and was scared about changing anything, even if it's deemed bio equivalent. My neuro was excellent, and took time explain my options. Essentially, at this point in time, one can either go on the generic or switch to the "long acting" 40 mg 3 x week copaxone. My neurologist agreed that it is not preferred to switch any DMD if it's working. He also briefly reviewed the stringent FDA process of approving generics. Our discussion got more interesting when I explained my glib understanding of what's in copaxone and that the FDA had to come up with new review process to figure out if the generic wAs similar ( which I detailed earlier in thread). He in essence concurred that this is all new and explained that neurologists and insurers were under tremendous pressure to treat and lower costs for MS. My hands are affected my MS. We decided it was best for me to switch to the 40mg 3 x week copaxone. This is protected by patent until 2030, so no generic until then unless patent found invalid.
The switch will mean I need to do 3 x a week dosing instead of 7. My dr said some people have noted side affects, like tightness of chest or skin swelling like in the daily 20mg. I will get option to have injection training again, if I wish. I also continue to get customer support from teva. I don't know what type of support the generic manufacturers will have. I know all of our different, and cost always plays an issue. I hope this info is helpful to all you on copaxone. Best wishes.
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