Announcement

Collapse
No announcement yet.

Generic Copaxone Approved by the FDA

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

    Generic Copaxone Approved by the FDA

    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.”




    http://www.fda.gov/NewsEvents/Newsro.../ucm443143.htm

    Even though the drug is approved, there are still legal hurdles to clear before it will come to market. Teva is not going to give up $3.1 billion in 2014 sales without a fight. Teva has been trying to move as many Copaxone patients to their newer 40-mg formula to preserve it's marketshare. Teva had hoped to switch 80% of their users to the longer acting 40 mg variant. Estimates suggest that 67% of users have switched to the newer dose. The Copaxone-40 has patent protection for another 15 years.

    In the next few years, patents for Rebif, Betaseron, Extavia and Avonex will all expire and hopefully equivalent and cheaper generics will hit the market. The MS community needs cheaper medications without patent and pricing gimmicks. Hopefully, we will not experience more shenanigans like we saw with Rituxan, Campath or Acthar Gel.

    #2
    Wonder what the Price

    will be by Sandoz (Don't they have to make up what it cost them to develop the generic?). Will it be that much of a savings per month or will it just be a reason for insurance companies to no longer pay for the brand name?

    Comment


      #3
      Marco --

      Thanks for sharing.

      My understanding is that the legal battle has already occurred and Teva won. My MS Specialist at KU Med Center talked about that in March, when I went for my appointment.

      But, I must not be understanding the whole picture. If there already has been a legal battle, I'm not sure how the FDA approval to market, that occurred today, fits in. Because I would have assumed that approval would have happened in the past, prior to the law suit.

      Can you explain to this numbskull how that all fits together? Or, is there a good link you could point me to?

      Thanks.
      ~ Faith
      MSWorld Volunteer -- Moderator since JUN2012
      (now a Mimibug)

      Symptoms began in JAN02
      - Dx with RRMS in OCT03, following 21 months of limbo, ruling out lots of other dx, and some "probable stroke" and "probable CNS" dx for awhile.
      - In 2008, I was back in limbo briefly, then re-dx w/ MS: JUL08
      .

      - Betaseron NOV03-AUG08; Copaxone20 SEPT08-APR15; Copaxone40 APR15-present
      - Began receiving SSDI / LTD NOV08. Not employed. I volunteer in my church and community.

      Comment


        #4
        FDA: “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,”

        That is a big LIE! In may be legally true, because they “have met” instead of “will have”, but the intent to deceive it there and that make it a big fat lie!
        FDA only requires generic drug companies to prove that they can make it, and not they are making it.
        No random quality test, No requirement to show that they buying the ingredients, No review what so ever.

        I know this may sound like good news to some, but for me it is bad news.
        Give life meaning, live life by the 9 Noble Virtues.

        Comment


          #5
          Originally posted by Mamabug View Post
          My understanding is that the legal battle has already occurred and Teva won.
          A patent lawsuit is ongoing. A federal appeals court is reviewing whether a key Teva patent, which expires in September, is valid. If the patent is upheld, Sandoz would have to decide whether to risk another lawsuit – and potentially substantial damages – by selling a generic before September. A spokeswoman for Sandoz, which handles marketing, declined to comment on the timetable.


          Wheeler also declined to discuss timing, but indicated the companies are ready to launch. He adds that the appeals court set an accelerated date for review, suggesting that a decision could occur in coming weeks. As for Teva, a spokeswoman writes us that “any companies that launch a generic version of Copaxone would do so at risk.” She declined to comment further or say when a ruling may be expected.

          from: http://blogs.wsj.com/pharmalot/2015/...ome-available/

          Comment


            #6
            How many lawsuits

            have there been? The Supreme Court heard a challenge to their patent well over a year ago. Gee, I wonder how much legal costs add to the cost of a drug!

            Comment


              #7
              OK, thanks Marco.
              ~ Faith
              MSWorld Volunteer -- Moderator since JUN2012
              (now a Mimibug)

              Symptoms began in JAN02
              - Dx with RRMS in OCT03, following 21 months of limbo, ruling out lots of other dx, and some "probable stroke" and "probable CNS" dx for awhile.
              - In 2008, I was back in limbo briefly, then re-dx w/ MS: JUL08
              .

              - Betaseron NOV03-AUG08; Copaxone20 SEPT08-APR15; Copaxone40 APR15-present
              - Began receiving SSDI / LTD NOV08. Not employed. I volunteer in my church and community.

              Comment


                #8
                Another related article on Copaxone from Israel news

                http://www.globes.co.il/en/article-t...ved-1001029146

                Comment


                  #9
                  Thanks. I sure want to follow this. Doesn't really affect me. I get Copaxone 40 free. Shared Solutions pays my $30 co-pay. But, I just think it's horrible, the amount of money that Teva makes off of my insurance company.
                  ~ Faith
                  MSWorld Volunteer -- Moderator since JUN2012
                  (now a Mimibug)

                  Symptoms began in JAN02
                  - Dx with RRMS in OCT03, following 21 months of limbo, ruling out lots of other dx, and some "probable stroke" and "probable CNS" dx for awhile.
                  - In 2008, I was back in limbo briefly, then re-dx w/ MS: JUL08
                  .

                  - Betaseron NOV03-AUG08; Copaxone20 SEPT08-APR15; Copaxone40 APR15-present
                  - Began receiving SSDI / LTD NOV08. Not employed. I volunteer in my church and community.

                  Comment


                    #10
                    Let's hope our insurance

                    companies don't want us to switch back to the 20mg in the generic form. Can they do that?

                    Comment


                      #11
                      Originally posted by its2much View Post
                      companies don't want us to switch back to the 20mg in the generic form. Can they do that?
                      There is no 40mg generic version so only the brand name would be available. The 40mg version has patent protection for an additional 15 years so obviously that is where Teva wants all of their patients. That's why Teva is pushing and pulling as many patients as possible to the newer dosing model.

                      Insurance companies use their formularies to steer patients and doctors into treatment regimes. Many patients are currently given the option to pay more for a brand drug or less for a generic version. At minimum, the insurance company would probably place the generic Copaxone into a less expensive category for the patient. In 2013, some insurance companies outright dropped Betaseron, but kept the cheaper Extavia medication on their formularies. Extavia is identical to Betaseron and simply branded differently. I'm not sure if a company could drop the name brand and offer only the generic version.

                      I believe Teva's current Copaxone profit margin is in the 80-90% range so there's plenty of room to undercut their price. We have no idea how much a generic Copaxone version would cost, but if there's substantial savings the insurance companies will likely try to steer patients to that version.


                      So Teva wants to drag patients to the 40 mg dose and insurance companies may want to push patients to the 20 mg generic dose.

                      Comment


                        #12
                        It all about the money, not us

                        Reuters article on business angle...
                        http://www.reuters.com/article/2015/...0NA0KU20150419


                        Originally posted by Mamabug View Post
                        Marco --

                        Thanks for sharing.

                        My understanding is that the legal battle has already occurred and Teva won. My MS Specialist at KU Med Center talked about that in March, when I went for my appointment.

                        But, I must not be understanding the whole picture. If there already has been a legal battle, I'm not sure how the FDA approval to market, that occurred today, fits in. Because I would have assumed that approval would have happened in the past, prior to the law suit.

                        Can you explain to this numbskull how that all fits together? Or, is there a good link you could point me to?

                        Thanks.
                        Jim S.

                        Comment


                          #13
                          Wednesday July 1st I called my specialty pharmacy to refill my Copaxone script. The person I spoke to raised the question of going with the generic. I didn't let that discussion go far because I pointed out that I am on the 40 mg for which there was no generic. That pretty much ended the conversation about the generic.

                          I guess that answers my question of whether or not the generic is available. There was no mention of cost. There was also no mention of switching back to 20 mg but I wouldn't have expected that question from the person in the specialty pharmacy anyway.

                          Comment


                            #14
                            General info:

                            My insurance (part D as of March this year) is now with CVS. They called 2 days ago and informed me that I will be switched automatically to the generic "C" on next order (July/August) unless my neuro supplies a script specific to "C".... Awaiting my neuro to comment... Should I really be concerned?

                            Jer

                            Ps. I'm 8 years with the 20 mg from Teva

                            Comment


                              #15
                              It didn't take Kaiser San Francisco long to switch me to Glatopa. As soon as the product was available the pharmacy notified me that I would be changed to the generic.

                              I have my first 30 shots in the fridge right now. I just can't wait to stick myself with it when my Copaxone runs out this coming monday.

                              I am hoping, just hoping the site reactions will be less painful than Copaxone. Probably too much to ask for, but wouldn't it be nice?
                              Jim S.

                              Comment

                              Working...
                              X