I thought this was a good article on the subject:
GH Jones et al, "Strategies that delay or prevent the timely availability of affordable generic drugs in the United States", Blood, March 17, 2016 (full text of article)
Forums
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: How generic drugs can be delayed or blocked
Thanks, Multibilly. I work in the generic drug industry, and this article is accurate. With so much money at stake, it’s very true that brand companies are constantly looking for “creative” ways to extend their already generous monopolies, more often than not - at the expense of governments, taxpayers, patients etc.
Given the focus on money, it’s really no wonder that un-patentable natural-plant based medicines will never be studied and funded for clinical research by big pharma, and that’s a real shame.
Karen
Given the focus on money, it’s really no wonder that un-patentable natural-plant based medicines will never be studied and funded for clinical research by big pharma, and that’s a real shame.
Karen
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KarenaD - Name: Karen
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: November 4, 2015
- Age at diagnosis: 54
Re: How generic drugs can be delayed or blocked
HI Karena,
At least one myeloma drug is now available in a generic version in Canada. That is bortezomib, by Teva. It is the generic for Velcade, by J&J. . You might know of other generic drugs, especially the ones used not as the chemotherapy, but as treatments for boosting blood counts, etc.?
At least one myeloma drug is now available in a generic version in Canada. That is bortezomib, by Teva. It is the generic for Velcade, by J&J. . You might know of other generic drugs, especially the ones used not as the chemotherapy, but as treatments for boosting blood counts, etc.?
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: How generic drugs can be delayed or blocked
Wow Nancy, I don't think a generic version of Velcade is available in the U.S.
Here is an article that was written by Matthew Perrone for the Associated Press and has been in several newspapers the last few days.
http://bigstory.ap.org/article/58abdb8532b148f298c8a8bdf27aae1d/no-clear-path-government-lowered-drug-prices
The above article is about drug prices generally and not specifically on generic drugs. Its main focus is on allowing government to negotiate drug prices to make them more affordable. It points out that last year alone pharmaceutical companies and related business spent more than $235 million on lobbying, more than any other industry. I also note that there is an ever growing use of TV advertising for prescription drugs that is being directed at the patient. Those adds cost a tremendous amount of money to produce and purchase time on national TV and therefore add to the cost we all pay.
Here is an article that was written by Matthew Perrone for the Associated Press and has been in several newspapers the last few days.
http://bigstory.ap.org/article/58abdb8532b148f298c8a8bdf27aae1d/no-clear-path-government-lowered-drug-prices
The above article is about drug prices generally and not specifically on generic drugs. Its main focus is on allowing government to negotiate drug prices to make them more affordable. It points out that last year alone pharmaceutical companies and related business spent more than $235 million on lobbying, more than any other industry. I also note that there is an ever growing use of TV advertising for prescription drugs that is being directed at the patient. Those adds cost a tremendous amount of money to produce and purchase time on national TV and therefore add to the cost we all pay.
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Ron Harvot - Name: Ron Harvot
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: Feb 2009
- Age at diagnosis: 56
Re: How generic drugs can be delayed or blocked
Hi Ron,
The generic version of bortezomib resulted from a court challenge regarding the length of time that the original patent for Velcade was in use, as I understand it. Now the generic version is being used, at a savings to the health care system. The generic version was introduced in May 2015. Here is a press release about the news:
http://www.newswire.ca/news-releases/teva-canada-announces-the-launch-of-prbortezomib-for-injection-a-generic-of-prvelcade-517410401.html
Velcade was the first drug I was given, as induction chemo, and I really credit it with saving my life. (Did you know that some of the research scientists behind the discovery of proteasome inhibitors won the Nobel Prize for chemistry? Dilip wrote to them and thanked them and they sent a nice reply too.)
I think that the Canadian and American systems of costs differ in that we have a national pricing system for expensive chemotherapy drugs. The cost is negotiated so that it will be the same across the country. This will help the provinces with smaller health care budgets to afford the same drugs as other provinces. Cost is a real factor in determining health care here.
The generic version of bortezomib resulted from a court challenge regarding the length of time that the original patent for Velcade was in use, as I understand it. Now the generic version is being used, at a savings to the health care system. The generic version was introduced in May 2015. Here is a press release about the news:
http://www.newswire.ca/news-releases/teva-canada-announces-the-launch-of-prbortezomib-for-injection-a-generic-of-prvelcade-517410401.html
Velcade was the first drug I was given, as induction chemo, and I really credit it with saving my life. (Did you know that some of the research scientists behind the discovery of proteasome inhibitors won the Nobel Prize for chemistry? Dilip wrote to them and thanked them and they sent a nice reply too.)
I think that the Canadian and American systems of costs differ in that we have a national pricing system for expensive chemotherapy drugs. The cost is negotiated so that it will be the same across the country. This will help the provinces with smaller health care budgets to afford the same drugs as other provinces. Cost is a real factor in determining health care here.
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: How generic drugs can be delayed or blocked
Nancy,
Thanks for the elaboration. Somehow the patents always seem to be extended in the U.S. to the benefit of the drug manufacturers and the detriment of the patient and insurance companies. I get the impression that the US consumer is being asked to bear all of the load. It appears that the big drug companies, which are forced to take less in Europe and Canada, make up for it by charging more in the US. With their massive lobbying efforts, our politicians are allowing them to continue doing it. Makes you wonder who the politicians really are working for.
Thanks for the elaboration. Somehow the patents always seem to be extended in the U.S. to the benefit of the drug manufacturers and the detriment of the patient and insurance companies. I get the impression that the US consumer is being asked to bear all of the load. It appears that the big drug companies, which are forced to take less in Europe and Canada, make up for it by charging more in the US. With their massive lobbying efforts, our politicians are allowing them to continue doing it. Makes you wonder who the politicians really are working for.
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Ron Harvot - Name: Ron Harvot
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: Feb 2009
- Age at diagnosis: 56
Re: How generic drugs can be delayed or blocked
Hi again Ron, I can't really comment on the US system, but it always did seem to me, since becoming more aware of the cost of some of these drugs, that a lower price would result in more sales. When you think of the fact that cancers occur across the whole world, then one would think that there is an international market for the drugs too. If the drug manufacturers prices approached the generic pricing, that might work. I think that actually some of the generic companies are offshoots of the major drug companies, although I don't have any press releases for that info. Actually I am grateful that there is some control over pricing here, since we are in a health care system without a secondary privately insured system. There are a lot of patients to treat, no doubt!
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: How generic drugs can be delayed or blocked
Hi Nancy and Ron,
Some examples of already genericized drugs in the US and Canada used in multiple myeloma treatment protocols include acyclovir, cyclophosphamide, dexamethasone, doxorubicin and zoledronic acid, but these are all older drugs.
Bortezomib does have a generic equivalent in Canada, but in the US, Fresenius Kabi’s “tentative generic approval” and other generic applicants are still tied up in patent litigation …although it appears generics could be on the market in the US by 2017:
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205004Orig1s000TAltr.pdf
http://www.fiercepharma.com/story/takeda-takes-unexpected-blow-blockbuster-velcade-patent-ruled-invalid/2015-08-24
Due to both legitimate patents and also the delaying tactics of brand companies, some of the newer drugs and biologic drugs used to treat multiple myeloma will likely not have generic or “biosimilar” versions for some time.
But, generic companies are finally making some modest headway in biologic drugs too. In September 2015 Sandoz launched its biosimilar version of Amgen’s “Neupogen” (GCSF)
https://www.novartis.com/news/media-releases/sandoz-launches-zarxiotm-filgrastim-sndz-first-biosimilar-united-states
and Apotex is currently in litigation with Amgen over its version of “Neulasta” (Peg-GCSF)
http://www.law360.com/articles/711335/apotex-accuses-amgen-of-sham-patent-litigation
As we know, Neupogen and Neulasta are great for treating neutropenia during chemotherapy and for boosting mobilization of stem cells prior to stem cell retrieval for transplant.
Karen
Some examples of already genericized drugs in the US and Canada used in multiple myeloma treatment protocols include acyclovir, cyclophosphamide, dexamethasone, doxorubicin and zoledronic acid, but these are all older drugs.
Bortezomib does have a generic equivalent in Canada, but in the US, Fresenius Kabi’s “tentative generic approval” and other generic applicants are still tied up in patent litigation …although it appears generics could be on the market in the US by 2017:
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205004Orig1s000TAltr.pdf
http://www.fiercepharma.com/story/takeda-takes-unexpected-blow-blockbuster-velcade-patent-ruled-invalid/2015-08-24
Due to both legitimate patents and also the delaying tactics of brand companies, some of the newer drugs and biologic drugs used to treat multiple myeloma will likely not have generic or “biosimilar” versions for some time.
But, generic companies are finally making some modest headway in biologic drugs too. In September 2015 Sandoz launched its biosimilar version of Amgen’s “Neupogen” (GCSF)
https://www.novartis.com/news/media-releases/sandoz-launches-zarxiotm-filgrastim-sndz-first-biosimilar-united-states
and Apotex is currently in litigation with Amgen over its version of “Neulasta” (Peg-GCSF)
http://www.law360.com/articles/711335/apotex-accuses-amgen-of-sham-patent-litigation
As we know, Neupogen and Neulasta are great for treating neutropenia during chemotherapy and for boosting mobilization of stem cells prior to stem cell retrieval for transplant.
Karen
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KarenaD - Name: Karen
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: November 4, 2015
- Age at diagnosis: 54
Re: How generic drugs can be delayed or blocked
Thanks Karen for your analysis of generics and posting those interesting links about bortezomib and Neupogen (Neulasta). Thanks Multibilly for starting this thread, and Ron for commenting too.
Good luck Karen on your treatments. I am sure you will do fine.
Good luck Karen on your treatments. I am sure you will do fine.
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: How generic drugs can be delayed or blocked
Hi Nancy,
Further to our recent discussion, please note that today Apotex launched “Grastofil”, the first biosimilar version of Neupogen (GCSF) in Canada.
http://www.newswire.ca/news-releases/launch-of-key-biosimilar-medicine-to-help-save-healthcare-budgets-574119711.html
Further to our recent discussion, please note that today Apotex launched “Grastofil”, the first biosimilar version of Neupogen (GCSF) in Canada.
http://www.newswire.ca/news-releases/launch-of-key-biosimilar-medicine-to-help-save-healthcare-budgets-574119711.html
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KarenaD - Name: Karen
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: November 4, 2015
- Age at diagnosis: 54
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