Importing Ibrucent (Generic Ibrutinib) from India

[LBfan]

I live in New Zealand where Ibrutinib is not funded. We understand a generic version Ibrucent (by Incepta) can be imported from India. Can anyone suggest a trustworthy website for purchase of this drug.

[Smith123456]

what do you consider trustworthy? India ignores patents because no one could afford the brands. However i do think the drug itself in India is legit and is a good generic. forbes.com/sites/johnlamatt...

[MaxSmart]

I’ve been to India many times and quite familiar with their pharmaceutical industry. China and India make most of the medications consumed by the west. For this medication and a reliable vendor I suggest you contact the manufacturer.

inceptapharma.com/product-d...

[Chinhdo in reply to MaxSmart]

I'm in Vietnam . 3 first months on Imbruvica from 4th month ( already 13 m) ,on Bangladesh generic Ibrutinib : Ibruxent, Ibrutix.. with the price 1/15 of Imbruvica . Thank God , I'm keeping good tendency as in beginning . What waits us without generics in developing countries...

[AussieNeil Administrator]

While I appreciate the challenges of those without access to an affordable CLL treatment and I'm well aware that some of our New Zealand members are importing generic BTK drugs from India, I haven't listed any Indian manufactured BTK drugs in this list

healthunlocked.com/cllsuppo... for the following reasons:-

1) Fake drugs are a huge international problem and unfortunately India is a major supplier

2) While India does produce generics that may be effective, without clinical trials, we really don't know the effectiveness of what is sold from India, nor the short and long term risk of adverse events and side effect profiles, or the actual dose of active ingredient. This is a major reason drugs from India undercut the costs of those legitimately supplied - Indian manufacturers don't have to recover the cost of funding clinical trials to prove their drugs are safe.

3) As Smith124456 mentioned, India ignores patents, so when you buy from India, you are at risk of loss of supply when your country takes action to ban the importation of drugs under patent protection. New Zealand is a signatory to international trade treaties which include agreement to mutually enforce patent protection of companies in the countries covered by said treaties. I've heard that the New Zealand government is under pressure to stop turning a blind eye to illegal imports from India, so if you are prepared to accept the above risks, you also need to have in place the means to purchase your BTK inhibitor drug from a legal source. There are very real risks associated with coming off a BTK inhibitor for longer than a week per this post: healthunlocked.com/cllsuppo...

I really hope your government can quickly come through with funding for non-chemo CLL treatments so that you aren't in this unenviable situation.

Neil

[MaxSmart in reply to AussieNeil]

Yes, but these so-called shoddy companies are actually the ones who manufacture the non-generic medications for American drug companies.

[Smith123456 in reply to MaxSmart]

Max- China surprisingly is aok when it comes to manufacture of drugs for western companies. they have state of the art manufacturing facilities. India however is a little circumspect-they have some state of the art facilities-and many that are not. I would trust my drugs made in china or singapore before india.

[Smith123456 in reply to AussieNeil]

Neil, I question some of what you say. Clinical trials have nothing to do with whats in a tablet or capsule. If you need to check a drug - a lab runs a chemical assay. If it's judged to be the equivalent of whats in a brand tablet or capsule it's ok. India ignores patents. Some of the manufacturers make legit copies of the drugs. From what i;ve been able to learn the problem in India is that many non-legit manufacturers there make phony copies.

[AussieNeil Administrator in reply to Smith123456]

I'm glossing over the details in that once a drug is approved by a government authority with the responsibility for oversight of clinical trials, such the FDA, that same government authority generally has the legal authority to independently do compliance checks to ensure that the approved drug continues to be made to the formulation approved during the clinical trial, e.g. fda.gov/inspections-complia...

In New Zealand, this comes under the responsibility of the Therapeutic Products Agency and in Australia, the Therapeutic Goods Administration.

Neil

[Jm954 Administrator]

If you’re interested in buying generic drugs from India or China you should listen to this podcast. This podcast is looking at those pharma factories under FDA jurisdiction so heaven knows what the quality assurance and management is like for those not under FDA scrutiny. Very worrying.

podcasts.apple.com/gb/podca...

Jackie

[Smith123456 in reply to Jm954]

my imbruvica is made in China. My venclexta is made in singapore

[SofiaDeo]

And in addition to all the above, India is currently going through a Covid crisis. Any Quality Assurance protocols Indian manufacturers put in place may not be monitored, if even done, considering the current strain.

[Smith123456]

Why the heck isn't new zealand supplying this drug. Australia does. We keep hearing how great New Zealand is with Covid and they can't supply ibrutinib to you?

[BSMI in reply to Smith123456]

Smith123, I agree. I’m in Australia where Imbruvica is basically free, thank goodness. I love NZ & am always envious of them. Just look at the way they handled the pandemic. So I was very surprised that Imbruvica isn’t covered there. Best of luck LBfan!

[Soultouch]

Hello all this is my first post but have been following you guys past several years. I am based in India.

Quick brief, was detected CLL (11q) in 2017 at the age of 33 and took FCR within a year of W&W. FCR treatment relapsed within a year and forced me to start Ibrutinib (Johnson) in 2019.

Within few months started Natco Ibrutinib who actually follows all patents and is a huge company. Infact it was in NY times and many top newspapers for the patent rights. The cost of the drug is 1500 USD a month in India and I have been taking it almost past 2 years with usual side effects and efficacy.

It’s not that I can’t afford the drug from US but all my doctors (even from US) think that there is nothing wrong with this version. My doctors in US/Singapore and India have supported my decision and till now I’ve been doing well.

Suggest you guys not to be very strong on the older preconceived notions and reconsider the research. I would love to know if there is anything am doing wrong.

Thanks all of you for the tremendous support and knowledge you guys have already given.

[Smith123456 in reply to Soultouch]

if your only paying 1500 us dollars a month they are ignoring PATENTS LAW. Making an exact copy of a drug-which i am sure they do-has nothing to do with honoring the MONEY the patent guarantees. 2 different things

[Soultouch in reply to Smith123456]

Smith I guess what you are saying makes sense that they are not following the drugs. Though they have USFDA (as mentioned on the drug packet & online) and some other approvals, they are maybe not following the patents law. You are right 👍

[AussieNeil Administrator in reply to Soultouch]

Would you please provide that online reference for USFDA approval for this Ibrutinib copy? I can only find references to the FDA documentation for the original Ibrutinib drug, not the copy.

Thanks,

Neil

[Smith123456 in reply to Soultouch]

Soultouch- i dont blame you at all. if i was in your situation i'd do the same thing. The west's patent laws make the ability to use live saving drugs in india practically impossible. some countries can only survive these diseases by ignoring patent laws. As long as you know the company is making a REAL copy and not a PHONY one that is the way to go.

[DJtheDJ]

I too live in New Zealand and faced the same problem with ibrutinib not been funded. I have 13q deletion and did FCR in 2015 and relapsed in 2016, my hematologist from Hamilton at the time could only offer me more Chemo. Then I did my research and found a BGB-3111 Trial at North Shore Hospital, Auckland, and getting on the Trial saved my life. It's name has changed to Zanabrutinib (Brukinsa in USA) , it's a highly effective second generation BTK inhibitor with very little if any side effects. I'm now in completed remission with no active disease in my bone marrow.I highly suggest trying to get on one of their local trials, no cost for the trial drugs, and the drugs are cutting edge. They have trials using acalabrutinib and a second generation Velenoclax, plus they have a world class Hematology department.

My heart goes out to you, I wish you all the best.

[Galah91]

I also live in NZ did the research globally was connected with my present Haematologist through his colleagues abroad, yes he is in Wellington. Diagnosis 2016 Lymphoma, 2018 Woldenstroem Macroglobulinemia with Bing Neel syndrome. Chemo to no avail then left to deal with it alone which I didn't accept I called out to the world for help. If the following link doesn't connect simply search - clinical trials ibrutinib wellington - malaghan institute

clinicaltrials.gov/ct2/show...

Meditation to help lessen the pain.

Warm hugs, and please stay in touch.

[morepork]

Hello from Wellington, NZ. In the interests of fact Ibrutinb WAS funded briefly via Janssen supplying it in 2016, and those of us who had haematologists on the ball at the time were lucky to get it as an ongoing free supply.(about 50 of us in NZ) My haematologist says Janssen put the drug forward to our drug buying agency but it was put on the maybe/maybe not list and it never became an approved drug. Venetoclax + Rituxan IS fully funded here and I'm aware of other BTK's on very small trials around the country.

[guzzifan]

LBfan, Since your doctor will have to prescribe the Ibrutinib before you can import it into NZ, could you ask him/her if he knows of a suitable supplier? He might know more than he is willing to volunteer, unless you specifically ask. You are going to need your doctor's continuing co-operation to get an on-going supply, so it might be advantageous to involve him in discussion right from the start.

This Medsafe link is a good start, if you want details of the process:

medsafe.govt.nz/Consumers/M...

I would be concerned about continuity of supply, with India's Covid-19 situation being out of control at the moment. If you don't receive an expected shipment, you can have quite a severe flare of disease, with no idea when your drugs will arrive.

I empathise with your situation, and hope that Pharmac will fund one of the BTK inhibitors soon. Haematologists have been lobbying them hard to do so. Good luck if you decide to go ahead with this.

Cheers. -Jim.

[LBfan]

Thank you for all your replies and information and support. I have some more research to do around trials etc. our specialist told us about being able to import direct from India but could not (or maybe would not) be more specific about trustworthy websites. I suspect because of all the patent issues etc that they don’t want to Cross that line (my suspicion only) . I fully appreciate the “ignoring of patent laws” and I would love to back Jansen/J&J for their R&D but my parents simply can’t afford $10k a month. I used to get cross when my kids pirated music. I also figure there are plenty of governments around the world funding this drug for their citizens so Jansen/J&J doing ok. I doubt my mum will be eligible for trials as she did not go thru chemotherapy first - IGHV unmutated. But I will certainly look and keep an eye out.

[LBfan]

Ps. Our specialist did say that Ibrucent by incepta had been tested in a Nz lab and found to be equivalent to the original. It appears from what some of you have said that the Natco one probably is to, but cannot buy direct from manufacturers so it’s finding a retailer that is selling the proper generic as opposed to phony generic. Incepta did not respond to my request for a trustworthy supplier.