Please talk to me about Herceptin biosimilars
Hi, everyone. I had my first infusion on Tuesday -- Taxol + Herceptin. Only I didn't learn until the Herceptin was already running that it was actually Ogivri (trastuzumab-dkst) -- apparently because my insurance wouldn't cover the original Herceptin. I'm irked that I wasn't told this prior to treatment, and will share that with my care team, but I don't seem to be having any unexpected side effects and am trying to figure out if this is something that I otherwise ought to be concerned about. From what I've read, I believe my MO would have had to sign off on the substitution. What should I be asking her? Is this something to push hard on?
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Hi Unrealtarheel,
This definitely sounds frustrating, and we agree, it probably should have been disclosed to you prior to infusion. Perhaps you can discuss with your MO why she did not share this information with you ahead of time?
You're sure to get some helpful responses here soon. In the meantime, you may be interested to read the main Breastcancer.org site's page on Herceptin Biosimilars.
We hope this helps!
--The Mods
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Thanks, Mods. I did look at that page already. It's a good start but still all kind of unsettling and confusing. It looks like the U.S. patents on Herceptin expired just last year, so there must be a lot of us suddenly facing this situation. Is there a possibility of doing a deeper dive? --Judy
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Judy, what types of information do you think you'd like to know? Perhaps we could consult with our editorial team and medical writers to see if they can help?
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Among the questions I have:
- Are there medical reasons that a doctor would preferentially prescribe a biosimilar? Or is the decision driven primarily by cost considerations or insurance limitations?
- I understand that Herceptin and the trastuzumab biosimilars derive from different animals. How similar can they really be?
- What about the side effect profile? Can a person have different experiences with the original agent vs. biosimilar?
- Are there other drawbacks? Advantages?
- In my case, I note that the primary efficacy study for Ogivri (HERITAGE study) was based on patients with metastatic breast cancer, but I have an early cancer. So, is the prescribing decision just based on what we know about Herceptin?
Thank you for considering.
ETA:- Who makes the decision about prescribing a biosimilar? Does my physician have to authorize?
- What should be my expectations as a patient? Shouldn't I be advised of the substitution? What if I have concerns?
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UnrealTarHeel- there is someone here SpecialK (I think is her name) that seems to know a lot about Herceptin and the biosimilars. She posted on someone else's thread about it. She is usually in the Triple Positive thread. I wish I could help but I had the Herceptin.
I hope your first treatment went well. Watch out for the possible 3rd day dip, where you may really feel bad. Drink lots of water/fluids to help flush your system. And eat whatever you feel like eating even if it's ice cream
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Thanks, @DogMomRunner. We were having a convo about this over on the Starting Chemo May 2020 chat because somebody had a bad reaction to one of the other biosimilars and now at least a couple of us are wondering what we need to know and whether we need to be concerned. I'll see if I can find SpecialK.
Good to know about the 3rd day. I felt kind of icky yesterday (day after infusion) and was hoping that night have been it. Trying to figure out now if my stuffy nose is trastuzumab-related or just more Carolina spring allergies.
And I saw your inquiry about leaving vs/ removing port. You are just about done!
ETA: Yes, I see the conversation in the Triple Positive group -- some of the same folks that are puzzling this out over in the May2020 group. It's hard not to feel like we're getting the biosimilar b/c the insurance company is cheap. :-(
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Hello. I posted last week about a question regarding the Herceptin/Biosimilars and it was answered by SpecialK. I was really freaked out with someone else posted about having a bad reaction to the biosimilar. I began researching like crazy because my first infusion was the next day. I ended up calling my insurance company that afternoon and found out that they do cover Herceptin as long as it had an order stating that I needed it. The insurance person I spoke to was clueless as to what a biosimilar was. The person who called to confirm my appointment at the hospital was also clueless as to what it was and she was a nurse. She called me back and she said that a doctor called her to explain a biosimilar and told me it was the exact same thing as herceptin. She said think of it like this: if you go to the store to buy Tylenol and end of having to buy the generic store brand of Acetaminopehn. In my opinion, a biosimilar is not the same thing. This is not a generic drug. The one that they were going to put me on was just FDA approved in June of 2019. It seems that the maker of the original Herceptin has been enjoying all of the proceeds from the drug and it was patented until May or June of 2019. The patent ended last year which is why the push to come up with similar drugs, but not the original. The biosimilar is cheaper. I could not find any long term studies with the biosimilar that was long term for anyone with an early stage. The one that they were going to put me on was in a clinical trial for 4 years. The FDA is trying to approve more biolsimilars. Also, the biosimilar that the FDA approved in June, was first denied by the FDA. Not sure why. I couldn't find any long term studies on biosimilars.
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This is what was posted on our May Chemo 2020 thread when we began questioning it.
“The FDA did not approve Kanjinti or any of the other biosimilars to Herceptin as interchangeable. They are not generics like acetaminophen is to brand name Tylenol. Many of the nurses and insurance clerks don't know the legal difference in the terminology. Generics use essentially the same recipe as the original. Biosimilars don't because they are made with different living organisms and are reverse engineered. Some of the doctors don't know the legal difference (or scientific significance.) Many don't independently research. They listen to and read the information provided by pharmaceutical representatives. Not an excuse, but one reason is the practice of medicine today is overwhelming in the amount of info and new developments.
Not being interchangeable does not mean the biosimilars don't work, that's part of the the problem. They are so newly FDA approved (Kanjinti in June 2019, I think) there isn't a history of years of clinical trials and in real life use in patients to prove they work the same as for Herceptin.The FDA approval is for being close enough in how Herceptin is made, not in how it works on the cancer cells in a patient's body. There's a lawsuit between the maker of Herceptin, Genentech, and the maker of Kanjinti.
Some oncologists aren't using biosimilars at all.... And for you to be the problem — no way. If they'd properly informed you instead of you having to push for information and defend your rights as a patient nothing would have been last minute.
It's all about money. Nothing wrong with saving money when appropriate but cutting corners without fully informing patients and getting informed consent from patients is wrong.
Here's a link to an article about the Genentech lawsuit against the makers of Kanjinti. Google to find more current info about the lawsuit which still is ongoing.
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Thanks for sharing this, PJAL. In looking around on these boards, it's clear that so many of us have so many questions.
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Cross posted from Starting Chemo April 2020
Hello Everybody!
Today, I had my first combo infusion of Dexamethasone — Diphenhydramine — Famotidine — Trastuzumab (Herceptin) — Paclitaxel (Taxol.) So far, i haven't had a significant reaction.
My two prior infusions were:
April 1 — Trastuzumab - anns, a biosimilar to Herceptin. I was supposed to get Trastuzumab (Herceptin.) I discovered several days later, instead of Herceptin I was I infused with Kanjinti. Kanjinti is not a FDA approved interchangeable. I had bad reactions to Kanjiniti during and after the infusion. No medications other than Kanjinti were infused. To try to control my vomiting during infusion (with the chemo nurse's approval) I took a total 16 mg ODT Ondansetron which I brought with me. For about 12 hours after the infusion, I continued nausea and vomiting, had diarrhea, chills, and a sustained fever of 102.5°. My normal temperature is ~97.5°. When the MO's office opened the next morning, i called and left a message for my MO and his PA about the reactions I'd experienced. I never heard from either of them.
I fired my MO of three years for his failure to disclose and failure to obtain my consent and failure to follow standard of care. Immediately prior to the infusion we talked about my quirky allergies to animal proteins and specifically my concern about a mouse based monoclonal antibodies to which a friend had violently reacted.
My friend had accompanied me to the MO visit the time before. After his reaction to Rituxin he was hospitalized for a week. My MO never mentioned Kanjinti or any biosimilar to Herceptin.. When I was infused with Kanjinti I didn't know it existed; I didn't know there were mouse protein based biosimilars to Herceptin.
Some of my allergies are life threatening. I have severe allergies to animal proteins. If not premedicated with steroids, Benadryl, and Pepcid, I pass out and go into respiratory failure if administered the mineral iodine which is used in contrast media for CTs scans. I was worried about the Chinese hamster ovary protein from which Herceptin is made and the possibility of reacting if I was infused as my friend did to a mouse protein based. The MO did not disclose he intended to infuse me with Kanjinti which is made from a mouse protein.
May 7 — Transtuzumaub, the "real" Herceptin, administered under the supervision of my new MO. I had no reactions during infusion. No medications other than Herceptin were infused. About 10 minutes after infusion ended, I developed a slight stuffy nose. In the next several hours the stuffy turned into my nasal passages being blocked as solidly as a brick and a mild asthma wheeze. I did an albuterol nebulizer treatment and used saline mist spray in my nose.
Five days after the infusion I had some dental work done. I developed increasingly severe pain in my left lower rib cage area that night/next day. I thought it was a catch in my side from turning my torso in the dental chair. The pain grew increasingly severe and peaked over the weekend. Neither my PCP, my MO, or I believe the problem was related to the dental visit or a heart problem from the Herceptin infusion. My PCP is thinking I passed a kidney stone. OUCH and my sympathies to anyone who has passed a kidney stone.
May 19 — Trastuzumab, the "real" Herceptin in the combo stated above. I developed a slight headache a few minutes after the steroid infusion ended. During the Taxol infusion, I slept for about 20 minutes, deep sleep not a little cat nap. Last night I couldn't sleep trying to keep myself from worrying about today's infusion. An asthma wheeze started after I got home. It was stronger wheeze than after Herceptin alone. I used my albuterol rescue inhaler twice and did one nebulizer treatment. I continued to have a wheeze. I'll do another nebulizer treatment before I go to bed. FYI: at my MO's request, I iced my hands/feet during the Taxol infusion and 15 minutes before and after to prevent neuropathy.If I have any more side effects from today's infusion, I'll supplement this post.
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I'll cross post this in the thread Unreal Tarheel (from the May 2020 Chemo) started specific to Herceptin and it's biosimilars. The biosimilar her MO used on her is Ogivri . If you are HER2+, Please read thread
Topic: Please talk to me about Herceptin biosimilars
https://community.breastcancer.org/forum/80/topics...
Please also read the biosimilar discussions in the May 2020 Chemo, Triple Positive, Bone Mets, and March 2020 Chemo threads.
In some of those thread, I engaged in discussion about biosimilars with two members who like me, have special knowledge about biosimilars. SpecialK has great depth and knowledge on this and other topics. Her discussion shows her to be knowledgeable and interested in helping others understand complex subjects.
Etnasgrl and I engaged in a spirited discussion in the March 2020 chemo group thread. I believe she is absolutely wrong when she states a biosimilar is the same as a generic. She quotes an information article written by BreastCancer.org to support her position Herceptin and it biosimilars are the same because both are made with living organisms.
That statement is at the core of why and how the real Herceptin and biosimilars never can be interchangeable. Herceptin is a monoclonal antibody. Mono meaning one animal. Clonal meaning the one animal is cloned to make the medicine.
Herceptin is made from cloning the protein of specific hamster(s). Kanjinti is made from cloning the protein of not just a different specific animal, it made from a different species — mice.
Etnasgrl disagreed with and rebuked most of what I said. Etnasgrl appears to have special knowledge and perspective on biosimilars. She has stated she works for an insurance company as an advocate.
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j
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Thank you for the detailed response, @ByHisGraceTwice. I'm sorry you're still having trouble, but hope that being on the original Herceptin is taking care of the worst reactions. One point that I'm confused about: Isn't it Herceptin that's made from the mouse proteins? Here is a blog post from Genentech, makers of Herceptin: https://www.gene.com/stories/her2/ ('To get around that problem, Carter, together with colleagues Michael Shepard, Len Presta and their teams, took the sections of the mouse antibody that would bind to HER2 and grafted them onto a human antibody, cleverly disguising it so it wouldn't be rejected – a so-called "humanized antibody."') That said, your point addresses exactly one of the things I've been wondering about -- can meds made from different animal proteins cause different reactions (either intended ones for treatment, or unintended ones such as side effects)? Clearly, that's been your experience!
I will go review those other threads and see what is new there.
@Moderators: You can see there are a lot of questions around this one. Any further thoughts about addressing with some updated content now that the Hereceptin patent has expired? Thank you for considering!
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unreal - Herceptin was originally developed with monoclonal antibody research done on mice, but the current large scale production by Genentech/Roche is accomplished with hamster ovary cells.
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Got it! Thank you to you both for the clarification. I wish I didn't feel like I need a degree in microbiology to be a patient...
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unreal - I know, right?
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Unreel and SpecialK — what's frightening is had i not taken a photo of the infusion bag I never would have known I wasn't getting Herceptin. I did it only to see the dosage amount I was getting. Several days post infusion after I felt better I looked at the photo and noticed “-anns," Googledand there began my research of Kanjinti which led to the other biosimilars.
Update: today first day post second infusion of the “real” Herceptin. No side effects except some steroids shakiness.
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j
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UnrealTarheel — did a little reading tonight on your biosimilar Ogivri. What I discovered is one of the ways I believe the manufacturers of the biosimilar decieve patients looking for information on clinical trials and testing. I cut and pasted a portion of rxlist.com describing side effects. The intro paragraph says (me paraphrasing ... the actual quote is below): you can't use another drug's trial results to compare apples to apples with ours, but that is exactly what we want you to think when we show you these charts on side effects.
Reminder — the scientific name for Ogivri is trastuzumab-dkst — Herceptin is trastuzumab. Notice all the column headings are only the scientific name of Herceptin. Ogivri's scientific name isn't mentioned once.
When I save this post the chart appears garbled. Follow the link to see the correct format
PS — my preliminary research reflects your Ogivri biosimilar is made from Chinese hamster ovary, but I want to confirm with a more credible source than rxlist.com.
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j
https://www.rxlist.com/ogivri-drug.htm#side_effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adjuvant Breast Cancer Studies
The data below reflect exposure to one-year trastuzumab therapy across three randomized, open-label studies, Studies 1, 2, and 3, with (n = 3678) or without (n = 3363) trastuzumab in the adjuvant treatment of breast cancer.
The data summarized in Table 3 below, from Study 3, reflect exposure to trastuzumab in 1678 patients; the median treatment duration was 51 weeks and median number of infusions was 18. Among the 3386 patients enrolled in the observation and one-year trastuzumab arms of Study 3 at a median duration of follow-up of 12.6 months in the trastuzumab arm, the median age was 49 years (range: 21 to 80 years), 83% of patients were Caucasian, and 13% were Asian.
Table 3 : Adverse Reactions for Study 3a, All Gradesb
Adverse Reaction One year Trastuzumab
(n = 1678)Observation
(n = 1708)Cardiac Hypertension 64 (4%) 35 (2%) Dizziness 60 (4%) 29 (2%) Ejection FractionDecreased 58 (3.5%) 11 (0.6%) Palpitations 48 (3%) 12 (0.7%) Cardiac Arrhythmiasc 40 (3%) 17 (1%) Cardiac Failure Congestive 30 (2%) 5 (0.3%) Cardiac Failure 9 (0.5%) 4 (0.2%) Cardiac Disorder 5 (0.3%) 0 (0%) Ventricular Dysfunction 4 (0.2%) 0 (0%) Respiratory Thoracic Mediastinal Disorders Cough 81 (5%) 34 (2%) Influenza 70 (4%) 9 (0.5%) Dyspnea 57 (3%) 26 (2%) URI 46 (3%) 20 (1%) Rhinitis 36 (2%) 6 (0.4%) Pharyngolaryngeal Pain 32 (2%) 8 (0.5%) Sinusitis 26 (2%) 5 (0.3%) Epistaxis 25 (2%) 1 (0.06%) Pulmonary Hypertension 4 (0.2%) 0 (0%) Interstitial Pneumonitis 4 (0.2%) 0 (0%) Gastrointestinal Disorders Diarrhea 123 (7%) 16 (1%) Nausea 108 (6%) 19 (1%) Vomiting 58 (3.5%) 10 (0.6%) Constipation 33 (2%) 17 (1%) Dyspepsia 30 (2%) 9 (0.5%) Upper Abdominal Pain 29 (2%) 15 (1%) Musculoskeletal & Connective Tissue Disorders Arthralgia 137 (8%) 98 (6%) Back Pain 91 (5%) 58 (3%) Myalgia 63 (4%) 17 (1%) Bone Pain 49 (3%) 26 (2%) Muscle Spasm 46 (3%) 3 (0.2%) Nervous System Disorders Headache 162 (10%) 49 (3%) Paraesthesia 29 (2%) 11 (0.6%) Skin & Subcutaneous Tissue Disorders Rash 70 (4%) 10 (0.6%) Nail Disorders 43 (2%) 0 (0%) Pruritus 40 (2%) 10 (0.6%) General Disorders Pyrexia 100 (6%) 6 (0.4%) Edema Peripheral 79 (5%) 37 (2%) Chills 85 (5%) 0 (0%) Asthenia 75 (4.5%) 30 (2%) Influenza-like Illness 40 (2%) 3 (0.2%) Sudden Death 1 (0.06%) 0 (0%) Infections Nasopharyngitis 135 (8%) UTI 39 (3%) Immune System Disorders Hypersensitivity 10 (0.6%) 1 (0.06%) Autoimmune Thyroiditis 4 (0.3%) 0 (0%) a Median follow-up duration of 12.6 months in the one-year trastuzumab treatment arm.
bThe incidence of Grade 3 or higher adverse reactions was < 1% in both arms for each listed term.
c Higher level grouping term.0 -
Thank you for this, ByHisGraceTwice, and do let me know what you find out about the source of Ogivri, although it may be a moot point for me. I spoke with the chemotherapy pharmacist yesterday who gave me some background about how Ogivri was chosen for me. Actually, it wasn't chosen only for me, and it wasn't just my insurance dictating the choice. Instead, it sounds like the physicians in the breast cancer group have decided to take a biosimilar-first approach. And it just happened to go into effect between when my treatment plan was described to me and when the treatment actually began. Obviously, that's where the insurance is coming down, too, but I do take some comfort in knowing that the insurance isn't the only driver. They are still going to look into whether Herceptin might be a possibility for me. And if that's not the case, I think I am going to hang this one up, albeit with some trepidation. I know that's not the choice everyone would make, which I totally respect. I do think this reinforces that a whole lot more of us are going to encounter these kinds of situations in the years to come now that the Herceptin patent has expired, and we sure could use more information.
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UnrealTarHeel
In this thread, I found a post by Nedsurvivor10. Herceptin working well for her for 10 years and they switched her to Kanjinti. She gets wretched side effects. 🤬
I can't find any other posts from her.
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j
Topic: HER2 Positive-anyone 10 years out?
https://community.breastcancer.org/forum/80/topics/740304?page=31#idx_927
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Thanks, ByHisGraceTwice: There is so much more that needs to be studied here! I was successfully switched over to Herceptin starting with my 2nd treatment this week. It actually seems to have increased my nosebleeds (!) but I'm still relieved not to have this question hanging over everything. So appreciate everyone taking the time to respond, and would still like to encourage BCO to consider an article or interview on this topic.
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I think this is a horrible thing! I just found out today that my insurance denied me herceptin but okay'd Kanjinti!!! What a joke. There are no long term studies about this for EBC. I broke down into tears all afternoon. It is so wrong for money to dictate what treatment I can have. If it was an antibiotic, or a tylenol tab, hey yeah I'd be okay...... BUT NOT treating my cancer! What do we do?
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I got kanjinti instead of herceptin and it was fine. I had a PCR to chemo/kanjinti/Perjeta. Kanjinti is a bio similar, it is not a “lesser” treatment. The scientific conclusion is that it was not meaningfully different from herceptin.
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