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May 14, 2020 08:14PM
May 15, 2020 09:57AM
Paula, I'm very proud of you for standing your ground today.
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.
Here's link to presentations by four experts about biosimilars:
Here's an FDA data sheet on Herceptin. (Page 2 — it's made from Chinese hamster ovary protein.)
Hope you're feeling ok tonight, Paula, and your side effects from Herceptin and Taxol aren't too tough. Tuesday night I'll be just like you are tonight. I'll have my second “real" Herceptin and my first Taxol infusion.
I'm proud of you.
11/18/2016, IDC, Right, 2cm, Stage IIA, Grade 2, ER+/PR+, HER2+ (IHC)
1/30/2017 Lumpectomy: Right
11/18/2019, IDC, Stage IV, metastasized to bone, Grade 2, ER+/PR+, HER2+ (FISH)
11/18/2019 External: Bone
3/13/2020, IDC, Stage IV, metastasized to bone
3/18/2020 External: Bone
5/7/2020 Herceptin (trastuzumab)
5/19/2020 Taxol (paclitaxel)