Genentech agrees to pay for ME/CFS patient's Rituximab

[BurnA]

The irony is that Genentech can swap around the additives in rituximab whenever they like and still call it rituximab. They can change the recipe a bit and nobody will know if it is any good any more and call it rituximab.

I think you are making it sound worse than it is. But maybe you aren't.

To change any ingredient would almost certainly result in a new licence apllication / regulatory approval.

I am fairly sure they cant change an ingredient without telling the approval authorities. They would then be asked to justify the change and demonstrate why it has no impact on the product. (potency, efficacy, safety etc)

 

[Gingergrrl]

@Jonathan Edwards If Genentech changed the ingredients of Rituxan, wouldn't they have to list this in the package insert in case someone was allergic? I'm not saying they can't legally do it b/c I don't know but wouldn't they have to disclose the ingredients?

Also, my doctor said the biosimilar versions are not available yet in the US. Is this incorrect?

 

[BurnA]

Also, my doctor said the biosimilar versions are not available yet in the US. Is this incorrect?

This might be of interest:

Biosimilars of Rituximab

 

[Jonathan Edwards]

I think you are making it sound worse than it is. But maybe you aren't.

To change any ingredient would almost certainly result in a new licence apllication / regulatory approval.

I am fairly sure they cant change an ingredient without telling the approval authorities. They would then be asked to justify the change and demonstrate why it has no impact on the product. (potency, efficacy, safety etc)

@Jonathan Edwards If Genentech changed the ingredients of Rituxan, wouldn't they have to list this in the package insert in case someone was allergic? I'm not saying they can't legally do it b/c I don't know but wouldn't they have to disclose the ingredients?

Also, my doctor said the biosimilar versions are not available yet in the US. Is this incorrect?

Gingergrrl's concern was about preservatives etc and although I think a company can change preservatives as long as it indicates that on the packet (which it would have to) and informs the authorities.

The main ingredient would remain rituximab but the company might decide to change the type of cell the rituximab is grown in. I am not clear whether or not this has to be declared. It would not appear on the packet. It might affect the potency of the drug. There have been issues about this in the past which have delayed the coming to market of other biologics. But once the drug is on the market I am not sure what the rules are. Big companies will want to make sure efficacy is the same as far as they can.

I think the point I am trying to make is that for minor ingredients that might be a problem there is no more guarantee that Genentech will continue to keep them the same than there is for any other company, but they will be declared on the bottle. For the mode of preparation of the drug, which might alter efficacy, I suspect again it is the same for both, but unlikely to be a big issue in either case. At the end of the day it makes sense to think Genentech rituximab is slightly more likely to be consistently the same as before but the difference may not be as great as one might think.

I think the biosimilars will become available when the current round of legal cases is finished. I don't think they are available yet.

 

[Jonathan Edwards]

This might be of interest:

Biosimilars of Rituximab

Yes, that fits with what I have been told. As I understand it the Celltrion version is approved in Europe and has passed its major trial hurdles in the last few months. The patent position in the US is different from Europe.

 

[BurnA]

I believe any generic company can call it retuximab but not Retuxan. One is a generic name and the other is the patented name, similar to ibuprofen vs advil.

Not to get too sidetracked or pedantic, but the naming convention for biosimilars appears different to generics.

The FDA recently issued a guidance document for naming of non-proprietary biologics. It seems a 4 letter suffix will be added to the originator name to distinguish it.

See more here

 

[Jill]

Ive been thru similar process here in Auckland. Clinical director of major hospital asked a senior rheumatologist to apply to NZ govt funding agency for rituxan. We knew they'd refuse. I know the clinical manager at Roche and he'd detailed to me how to apply to them. We asked that his be done. The next thing we find out is that the senior rheumatologist had pulled his help citing that he might loose his reputation for using a drug off label. What a punk. Says in one appointment he'll help all the way, then side steps and refuses to see us. Thankfully I worked out my partner has low ADH and he has been helped out of his bed ridden state by demopressin. After 3 hospital admissions no body bothered to read what I had detailed as "excessive thirst and lots of peeing thru the night. I didn't go to all the trouble of writing case history and current symptoms for fun! The clinical director then asks " why didn't you say anything" I referred him to my exhaustive list of symptoms and said since he was a endocrinologist he should have picked up on symptoms in his domain and followed them thru. THAT is what I had expected each specialist to do - not to ignore the symptom list and make up their own minds. Never mind he is helping now, but its been a F&*kin long battle with legal threats.
BTW the Desmopressin has helped a wide range of symptoms - from brain to pain. In his case its been very worthwhile.

 

[Nickster]

Thanks for tagging me, J, and my understanding is that Genentech does have a patient assistance program for patients for Rituximab (like they do for Valcyte) but you have to be rejected by insurance first in order to even apply for it. My doctor is not using ME/CFS as my diagnosis for requesting RTX vs. other multiple other B-cell dependent autoimmune issues combined w/my very positive response to autoimmune dosing of IVIG. I have now done ten months of IVIG (6-7 months at the high dose) and IVIG would be far more expensive, and could be ongoing for years, vs. two infusions of RTX could do the same thing and lead to permanent remission (best case scenario of course)!

We waited to request the Auth so I would not lose my remaining IVIG but now that I only have one cycle of IVIG left (mid-May), we have put in the request. My doctor feels very optimistic that we will get RTX covered but no longer in May and we are now aiming for June b/c many hoops to jump through. I would still pay infusion & hospital co-pays but hoping to get the RTX itself covered. But if we exhaust all options, I will not hesitate to apply for patient assistance from Genentech. I will find a way to try RTX (if it's the last thing I do on earth!), b/c it is the only med I have found that has the possibility to destroy the B-cells and the new ones grow back auto-antibody free (again best case scenario like I said). IVIG is just a temporary fix and no idea what will happen once I stop it.

Thanks to Jesse and all who tag me in these threads re: IVIG or RTX, I truly appreciate it!

So does this mean that we can get treatment in the US and possibly get cured? Does OMI use Rituximab? If so, any success with it? @Gingergrrl @Jesse2233
My son Nick saw Dr Chheda in November, but, she did not have anything like this available. Maybe I should reach out to her agian. Just trying to get some help for my son. Thanks!
Ann

 

[Gingergrrl]

Gingergrrl's concern was about preservatives etc and although I think a company can change preservatives as long as it indicates that on the packet (which it would have to) and informs the authorities.

Thanks for clarifying and answering my question on this and I figured if they changed the inactive ingredients or fillers/additives that they would have to list it on the package insert.

Yes, that fits with what I have been told. As I understand it the Celltrion version is approved in Europe and has passed its major trial hurdles in the last few months. The patent position in the US is different from Europe.

This was my understanding from my doctor as well (that the biosimilars are not yet available in the U.S.)

Never mind he is helping now, but its been a F&*kin long battle with legal threats.

@Jill, does this mean that your husband/partner has now been approved for Ritux or am I misunderstanding? I remember you had a long battle going and am hoping that you won!

So does this mean that we can get treatment in the US and possibly get cured? Does OMI use Rituximab? If so, any success with it? @Gingergrrl @Jesse2233

OMI does prescribe Ritux in cases where they think it is clinically appropriate. They have split into two offices and my understanding from all of the e-mails is that BOTH offices will continue to prescribe Ritux. When I began there in 2014, Ritux was not even considered for me as clinically appropriate as we thought my case to be purely viral vs. now we know it has become autoimmune. I would never refer to Ritux as a "cure" but I am hoping it will reverse my remaining symptoms that have not been helped by IVIG. If it can do this, I will be thrilled (but no guarantee that it can and am going into this with eyes wide open). Am still pending insurance approval (for the Ritux not the IVIG) which is a long process.

 

[Nickster]

Thanks for clarifying and answering my question on this and I figured if they changed the inactive ingredients or fillers/additives that they would have to list it on the package insert.



This was my understanding from my doctor as well (that the biosimilars are not yet available in the U.S.)



@Jill, does this mean that your husband/partner has now been approved for Ritux or am I misunderstanding? I remember you had a long battle going and am hoping that you won!



OMI does prescribe Ritux in cases where they think it is clinically appropriate. They have split into two offices and my understanding from all of the e-mails is that BOTH offices will continue to prescribe Ritux. When I began there in 2014, Ritux was not even considered for me as clinically appropriate as we thought my case to be purely viral vs. now we know it has become autoimmune. I would never refer to Ritux as a "cure" but I am hoping it will reverse my remaining symptoms that have not been helped by IVIG. If it can do this, I will be thrilled (but no guarantee that it can and am going into this with eyes wide open). Am still pending insurance approval (for the Ritux not the IVIG) which is a long process.

@Gingergrrl
Thank you for sharing your experiences. Glad to hear the IVIG has helped. Please keep us posted with your treatments. You are cautiosly optimistic which I understand as my son and I have had many disappointments. I hope that you will have success with Ritux and wish you the best!
Ann

 

[Jill]

@Gingergrrl , no rituxan hasn't been applied for to Roche unfortunately . What I was meaning really was that the clinical director is now his dr and is willing to prescribe and monitor the Desmopressin and I think slowly he is realising this is a real illness . Al now has 2 Drs. Carl the clinical director and Paul a pain specialist and psychiatrist , both of whom have had to come to the house . With the Desmopressin al can get to their clinics now ( fortunately not a long drive only 5 mins ). Thanks for remembering my battle. I feel proud to have got these people to the house and got social services as well. It shows me what can be done , when I was told initially it couldn't be done . So, we are not paying for care which is what my complaint boiled down too - that people with this level of disability with other illnesses are treated in the system, and folllowed 3 or 6 monthly so they are not lost and forgotten . My grand rounds talk ended on ' ME deserves equality with other serious illnesses'.

So so please to read of the approval of rituxan for your case . Will be following with bated breath ))

 

[BurnA]

Not sure if this has been discussed or mentioned anywhere else yet.

http://mobile.reuters.com/article/idUSKBN19A0IQ

Switzerland's Novartis increased pressure on Roche's ageing stable of big-selling drugs on Monday by becoming the latest company to win European approval for a cut-price version of Rituxan for blood cancer and immunological diseases.

 

[voner]

Not sure if this has been discussed or mentioned anywhere else yet.

http://mobile.reuters.com/article/idUSKBN19A0IQ

Switzerland's Novartis increased pressure on Roche's ageing stable of big-selling drugs on Monday by becoming the latest company to win European approval for a cut-price version of Rituxan for blood cancer and immunological diseases.

hey @BurnA, thanks for posting that press release.

here's something that I found interesting ... ($7.5 billion dollars in annual sales!! and Novartis is filing for approval in the United States later this year.. very good news)

Rituxan, also known as MabThera, racked up 7.3 billion Swiss francs ($7.50 billion) in global sales in 2016 and costs tens of thousands per year.

Novartis is counting on cash-strapped healthcare systems and cost-conscious insurance companies to favor cheaper versions that trials show are as effective. Britain, for example, has set a target for 90 percent of new patients treated in its hospitals to get so-called biosimilars.

"Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be one of the five major launches we plan in the next four years," Carol Lynch, Sandoz's global head of biopharmaceuticals, said in a statement.

Novartis aims to up the ante later this year by filing for approval of its version of Rituxan in the United States.