HonCode

Go Back   HER2 Support Group Forums > her2group
Register Gallery FAQ Members List Calendar Search Today's Posts Mark Forums Read

Reply
 
Thread Tools Display Modes
Old 01-29-2013, 07:26 AM   #1
Joan M
Senior Member
 
Joan M's Avatar
 
Join Date: Oct 2007
Posts: 1,851
Generic Hercpetin coming soon to your cancer center?

A story in today's New York Times discusses the development of a generic version of Herceptin. Such a biosimilar drug would have a tremendous impact on us.

Genentech will lose fairly soon its patent protection on Herceptin (trastuzumab), and has been lobbying against a biosimilar substitute.

According to the news story, "Biotech drugs, known in the industry as biologics, are much more complex than pills like Lipitor or Prozac. That makes it extremely difficult to tell if a copy of a biological drug is identical to the original. Even slight changes in the cells that make the proteins can change the drug’s properties."

http://www.nytimes.com/2013/01/29/bu...ef=todayspaper

Despite the high cost of Herceptin, I'm very worried about this.

Joan
__________________
Diagnosed stage 2b in July 2003 (2.3 cm, HER2+, ER-/PR-, 7+ nodes). Treated with mastectomy (with immediate DIEP flap reconstruction), AC + T/Herceptin (off label). Cancer advanced to lung in Jan. 2007 (1 cm nodule). Started Herceptin every 3 weeks. Lung wedge resection April 2007. Cancer recurred in lung April 2008. RFA of lung in August 2008. 2nd annual brain MRI in Oct. 2008 discovered 2.6 cm cystic tumor in left frontal lobe. Craniotomy Oct. 2008 (ER-/PR-/HER2-) followed by targeted radiation (IMRT). Coughing up blood Feb. 2009. Thoractomy July 2009 to cut out fungal ball of common soil fungus (aspergillus) that grew in the RFA cavity (most likely inhaled while gardening). No cancer, only fungus. Removal of tiny melanoma from upper left arm, plus sentinel lymph node biopsy in Feb. 2016. Guardant Health liquid biopsy in Feb. 2016 showed mutations in 4 subtypes of TP53. Repeat of Guardant Health biopsy in Jana. 2021 showed 3 TP53 mutations, BRCA1 mutation and CHEK2 mutation. Invitae genetic testing showed negative for all of these. Living with MBC since 2007. Stopped Herceptin Hylecta (injection) treatment in March 2020. Recent 2021 annual CT of chest, abdomen and pelvis and annual brain MRI showed NED. Praying for NED forever!!
Joan M is offline   Reply With Quote
Old 01-29-2013, 01:22 PM   #2
Lani
Senior Member
 
Join Date: Mar 2006
Posts: 4,778
Re: Generic Hercpetin coming soon to your cancer center?

I am also worried about the cold chain method of delivery and pirating.

Herceptin should NEVER GET OUTSIDE the 2-8 degree centigrade (36-46 degree Fahrenheit) at any time between manufacture and being mixed up to be administered. Genentech has the delivery mechanism perfected, other companies may not. There should be smart chips on each vial to ensure they never get outside the correct temperature range, but noone wants to do it.

More companies making it may also make it easier for piraters to try to pass off fake herceptin. I think the smart chip could serve to prevent this.

There is too much money involved here to not take every step possible to make sure what is in the vial is both effective and what it claims to be , let alone ther problems with manufacturing equivalent drug.

My two cents.
Lani is offline   Reply With Quote
Old 01-29-2013, 03:52 PM   #3
Joan M
Senior Member
 
Joan M's Avatar
 
Join Date: Oct 2007
Posts: 1,851
Re: Generic Hercpetin coming soon to your cancer center?

Lani, your two cents is very much appreciated. I'd heard about this a few years ago and the clock has continued to tick. Joan
__________________
Diagnosed stage 2b in July 2003 (2.3 cm, HER2+, ER-/PR-, 7+ nodes). Treated with mastectomy (with immediate DIEP flap reconstruction), AC + T/Herceptin (off label). Cancer advanced to lung in Jan. 2007 (1 cm nodule). Started Herceptin every 3 weeks. Lung wedge resection April 2007. Cancer recurred in lung April 2008. RFA of lung in August 2008. 2nd annual brain MRI in Oct. 2008 discovered 2.6 cm cystic tumor in left frontal lobe. Craniotomy Oct. 2008 (ER-/PR-/HER2-) followed by targeted radiation (IMRT). Coughing up blood Feb. 2009. Thoractomy July 2009 to cut out fungal ball of common soil fungus (aspergillus) that grew in the RFA cavity (most likely inhaled while gardening). No cancer, only fungus. Removal of tiny melanoma from upper left arm, plus sentinel lymph node biopsy in Feb. 2016. Guardant Health liquid biopsy in Feb. 2016 showed mutations in 4 subtypes of TP53. Repeat of Guardant Health biopsy in Jana. 2021 showed 3 TP53 mutations, BRCA1 mutation and CHEK2 mutation. Invitae genetic testing showed negative for all of these. Living with MBC since 2007. Stopped Herceptin Hylecta (injection) treatment in March 2020. Recent 2021 annual CT of chest, abdomen and pelvis and annual brain MRI showed NED. Praying for NED forever!!
Joan M is offline   Reply With Quote
Old 01-29-2013, 07:12 PM   #4
KDR
Senior Member
 
KDR's Avatar
 
Join Date: Aug 2010
Location: New York, New York
Posts: 1,580
Re: Generic Hercpetin coming soon to your cancer center?

I have often worried about this, and thank you both for posting.

I also have a feeling that the name institutional facilities will have less of an issue whereas smaller doctor's offices might lack the power or prowess of insistance?

The patient would have to be told they are getting generic drugs, right? Interestingly, I take Synthroid, but cannot take the generic, Levothyroxine. Within three days, I will be flat.

Oh, the politics of this game. Imagine if the FDA changed course--just a little--how much we could bring down the national debt?

Karen
KDR is offline   Reply With Quote
Old 02-09-2013, 05:24 PM   #5
Joan M
Senior Member
 
Joan M's Avatar
 
Join Date: Oct 2007
Posts: 1,851
Re: Generic Hercpetin coming soon to your cancer center?

Here's a short opinion piece about the issue of developing a generic, or biosimilar version, of Herceptin. The opinion appeared today in The New York Times.

http://www.nytimes.com/2013/02/09/op...ef=todayspaper

In the last decade, the development and manufacture of targeted cancer drugs has far surpassed that of chemotherapy. Targeted drugs have made an impact on survival, but chemo still being the backbone of cancer treatment. Although the FDA can issue guidelines on the development of biosimilars, who's going to oversee that?

Joan

Improper Efforts to Limit Competitive Drugs
February 9, 2013

Two big biotechnology companies, Amgen and Genentech, are lobbying state legislatures to limit competition to their biological drugs that will lose patent protection in the next several years. Before taking any action, lawmakers should wait for guidance from the Food and Drug Administration, the agency that reviews all drugs and their generic versions for safety and effectiveness.

Biological drugs are made from large molecules, and the processes, involving living cells, are more complex than those used to make conventional drugs. The cheaper competitors to brand-name biological drugs are called “biosimilars” to indicate that they are not exact copies but are close enough to work the same way.

American consumers, insurers and health care providers could potentially save billions of dollars a year by using cheaper versions of brand-name biologicals that now cost tens or hundreds of thousands of dollars a year per patient. States should not move to limit access to biosimilar drugs before the F.D.A. has issued final guidelines on how to ensure their safety. In their lobbying campaign, revealed by Andrew Pollack in The Times recently, the two companies have persuaded legislators to introduce bills that would restrict the ability of pharmacists to substitute cheaper biosimilars in filling prescriptions.

The Affordable Care Act empowered the Food and Drug Administration to use an accelerated process to determine whether a biosimilar drug could be deemed “interchangeable” with the brand-name drug for clinical purposes. Once a biologic is deemed interchangeable, it can be substituted by pharmacists without permission from a doctor. Biosimilars are unlikely to be available in this country for at least two years, though more than a dozen have been approved in Europe with no evidence of adverse consequences.

Amgen and Genentech say they want state laws to protect patient safety. But it makes more sense for the states to see what the F.D.A. does first before imposing administrative hurdles on pharmacists and patients — like requiring a patient’s consent every time a substitution is made — when using less expensive biosimilar drugs.
__________________
Diagnosed stage 2b in July 2003 (2.3 cm, HER2+, ER-/PR-, 7+ nodes). Treated with mastectomy (with immediate DIEP flap reconstruction), AC + T/Herceptin (off label). Cancer advanced to lung in Jan. 2007 (1 cm nodule). Started Herceptin every 3 weeks. Lung wedge resection April 2007. Cancer recurred in lung April 2008. RFA of lung in August 2008. 2nd annual brain MRI in Oct. 2008 discovered 2.6 cm cystic tumor in left frontal lobe. Craniotomy Oct. 2008 (ER-/PR-/HER2-) followed by targeted radiation (IMRT). Coughing up blood Feb. 2009. Thoractomy July 2009 to cut out fungal ball of common soil fungus (aspergillus) that grew in the RFA cavity (most likely inhaled while gardening). No cancer, only fungus. Removal of tiny melanoma from upper left arm, plus sentinel lymph node biopsy in Feb. 2016. Guardant Health liquid biopsy in Feb. 2016 showed mutations in 4 subtypes of TP53. Repeat of Guardant Health biopsy in Jana. 2021 showed 3 TP53 mutations, BRCA1 mutation and CHEK2 mutation. Invitae genetic testing showed negative for all of these. Living with MBC since 2007. Stopped Herceptin Hylecta (injection) treatment in March 2020. Recent 2021 annual CT of chest, abdomen and pelvis and annual brain MRI showed NED. Praying for NED forever!!

Last edited by Joan M; 02-09-2013 at 05:30 PM..
Joan M is offline   Reply With Quote
Old 02-10-2013, 07:16 PM   #6
1rarebird
Senior Member
 
Join Date: Feb 2010
Location: TN
Posts: 175
Re: Generic Hercpetin coming soon to your cancer center?

I don't quite understand this. It appears to me that before a bio-similar form of Herceptin could be allowed by FDA there would have to be clinical trials to prove the saftey and effectiveness of the new generic form of the medicine. Fighting Her 2+ breast cancer with anything but the best agents is risking too much IMHO.---bird
__________________
Male Breast Cancer, DX 5/15/09, IDC, STAGE 1, 1.7 cm, HER2+++, ER+(95%)/PR+(75%), Ki67 40%, grade 3, 0/5 nodes, TX: mastectomy, TCH finished 7/19/10, radiation 6 wks., Tamoxifen on going, bisphosphonate 24 mos.
1rarebird is offline   Reply With Quote
Old 02-11-2013, 12:20 AM   #7
Joanne S
Senior Member
 
Joanne S's Avatar
 
Join Date: Aug 2007
Location: Detroit Metropolitan Area, Michigan
Posts: 592
Re: Generic Hercpetin coming soon to your cancer center?

I read the article and many of the interesting comments and views too. In the end, I just don't know what to think or who to believe? I certainly don't trust the FDA. Look at all the toxins they continue to allow in our food. There may be much greed on all involved - all I know is - that seems to be the norm lately.

What's most important? What's most valuable? Health and Life.
Who is most important in this situation? We are.
Could the bio-similar possibly be the same or better than the Herceptin?
Who is really looking out for us? Who do we trust?
Attached Images
  

Last edited by Joanne S; 02-11-2013 at 12:32 AM..
Joanne S is offline   Reply With Quote
Old 02-11-2013, 04:27 AM   #8
sarah
Senior Member
 
Join Date: Sep 2005
Location: france
Posts: 1,648
Re: Generic Hercpetin coming soon to your cancer center?

Hmm, interesting. If Genetech charged the same as a generic, surely everyone would keep using Genetech's Herceptin???
__________________
sarah is offline   Reply With Quote
Old 02-11-2013, 06:56 PM   #9
1rarebird
Senior Member
 
Join Date: Feb 2010
Location: TN
Posts: 175
Re: Generic Hercpetin coming soon to your cancer center?

Could we be missing something here? I believe a generic form of a pharmaceutical has the same chemical compound only made by a different company and usually sold at a lesser price. These bio-similar drugs don't sound like generic forms of the original drug. They are similar but not the same. So with Herceptin's unique and time-proven formulation, it seems risky to substitue something else "bio-similar" (similar not being the same) unless it has been shown through clinical trials to be as effective and safe as the original Herceptin. Just my 2 cents worth---bird
__________________
Male Breast Cancer, DX 5/15/09, IDC, STAGE 1, 1.7 cm, HER2+++, ER+(95%)/PR+(75%), Ki67 40%, grade 3, 0/5 nodes, TX: mastectomy, TCH finished 7/19/10, radiation 6 wks., Tamoxifen on going, bisphosphonate 24 mos.
1rarebird is offline   Reply With Quote
Old 02-11-2013, 07:07 PM   #10
Jackie07
Senior Member
 
Jackie07's Avatar
 
Join Date: Jan 2008
Location: "Love never fails."
Posts: 5,808
Re: Generic Hercpetin coming soon to your cancer center?

The abstract below might shed some light ...

Expert Opin Biol Ther. 2013 Feb;13(2):153-6. doi: 10.1517/14712598.2012.758710. Epub 2013 Jan 4.
Biosimilar monoclonal antibodies: a science-based regulatory challenge.

Declerck PJ.
Source

University of Leuven, Laboratory for Therapeutic and Diagnostic Antibodies, Department of Pharmaceutical and Pharmacological Sciences , Campus GHB, ON2, PB 824, 3000 Leuven , Belgium +32 16 323431 ; paul.declerck@pharm.kuleuven.be.

Abstract

Monoclonal antibodies (MAs) are complex biotherapeutics as their molecular mechanism of action depends on multiple domains. Consequently regulatory approval of biosimilars of MAs is subjected to specific, science-based guidelines. An extensive comparative in vitro characterization to evaluate the biosimilarity of the various functional domains is required. The exquisite species specificity of MAs precludes reliable in vivo non-clinical evaluations and means that adequately designed clinical studies are extremely critical to confirm the biosimilarity.

To date no biosimilar MAs have been approved. Taking into account the expected high development costs for biosimilar MAs, their use may well be superseded by alternative antibody formats and next-generation MAs.
__________________
Jackie07
http://www.kevinmd.com/blog/2011/06/doctors-letter-patient-newly-diagnosed-cancer.html
http://www.asco.org/ASCOv2/MultiMedi...=114&trackID=2

NICU 4.4 LB
Erythema Nodosum 85
Life-long Central Neurocytoma 4x5x6.5 cm 23 hrs 62090 semi-coma 10 d PT OT ST 30 d
3 Infertility tmts 99 > 3 u. fibroids > Pills
CN 3 GKRS 52301
IDC 1.2 cm Her2 +++ ER 5% R. Lmptmy SLNB+1 71703 6 FEC 33 R Tamoxifen
Recc IIB 2.5 cm Bi-L Mast 61407 2/9 nds PET
6 TCH Cellulitis - Lymphedema - compression sleeve & glove
H w x 4 MUGA 51 D, J 49 M
Diastasis recti
Tamoxifen B. scan
Irrtbl bowel 1'09
Colonoscopy 313
BRCA1 V1247I
hptc hemangioma
Vertigo
GI - > yogurt
hysterectomy/oophorectomy 011410
Exemestane 25 mg tab 102912 ~ 101016 stopped due to r. hip/l.thigh pain after long walk
DEXA 1/13
1-2016 lesions in liver largest 9mm & 1.3 cm onco. says not cancer.
3-11 Appendectomy - visually O.K., a lot of puss. Final path result - not cancer.
Start Vitamin D3 and Calcium supplement (600mg x2)
10-10 Stopped Exemestane due to r. hip/l.thigh pain OKed by Onco 11-08-2016
7-23-2018 9 mm groundglass nodule within the right lower lobe with indolent behavior. Due to possible adenocarcinoma, Recommend annual surveilence.
7-10-2019 CT to check lung nodule.
1-10-2020 8mm stable nodule on R Lung, two 6mm new ones on L Lung, a possible lymph node involvement in inter fissule.
"I WANT TO BE AN OUTRAGEOUS OLD WOMAN WHO NEVER GETS CALLED AN OLD LADY. I WANT TO GET SHARP EDGED & EARTH COLORED, TILL I FADE AWAY FROM PURE JOY." Irene from Tampa

Advocacy is a passion .. not a pastime - Joe
Jackie07 is offline   Reply With Quote
Old 02-11-2013, 07:43 PM   #11
Joan M
Senior Member
 
Joan M's Avatar
 
Join Date: Oct 2007
Posts: 1,851
Re: Generic Hercpetin coming soon to your cancer center?

The FDA has already developed some draft industry guidance for biosimilars:

http://www.fda.gov/downloads/Drugs/G.../UCM291128.pdf

http://www.fda.gov/downloads/Drugs/G.../UCM291134.pdf

Thanks for your comments and the link. I belong to a group of women that meets monthly to discuss bc issues, and we're planning to discuss this topic in the spring.

Joanne, I like your ATM cartoon. It reminds me of a similar cartoon I saw in the early 80s in Newsweek, except the patient was hooked up to a parking meter. That was the era when insurance companies first started to dictate how long patients could remain in a hospital depending on their procedure, in order for the insurance company to fully cover the hospital stay.

Joan
__________________
Diagnosed stage 2b in July 2003 (2.3 cm, HER2+, ER-/PR-, 7+ nodes). Treated with mastectomy (with immediate DIEP flap reconstruction), AC + T/Herceptin (off label). Cancer advanced to lung in Jan. 2007 (1 cm nodule). Started Herceptin every 3 weeks. Lung wedge resection April 2007. Cancer recurred in lung April 2008. RFA of lung in August 2008. 2nd annual brain MRI in Oct. 2008 discovered 2.6 cm cystic tumor in left frontal lobe. Craniotomy Oct. 2008 (ER-/PR-/HER2-) followed by targeted radiation (IMRT). Coughing up blood Feb. 2009. Thoractomy July 2009 to cut out fungal ball of common soil fungus (aspergillus) that grew in the RFA cavity (most likely inhaled while gardening). No cancer, only fungus. Removal of tiny melanoma from upper left arm, plus sentinel lymph node biopsy in Feb. 2016. Guardant Health liquid biopsy in Feb. 2016 showed mutations in 4 subtypes of TP53. Repeat of Guardant Health biopsy in Jana. 2021 showed 3 TP53 mutations, BRCA1 mutation and CHEK2 mutation. Invitae genetic testing showed negative for all of these. Living with MBC since 2007. Stopped Herceptin Hylecta (injection) treatment in March 2020. Recent 2021 annual CT of chest, abdomen and pelvis and annual brain MRI showed NED. Praying for NED forever!!

Last edited by Joan M; 02-11-2013 at 07:51 PM..
Joan M is offline   Reply With Quote
Old 02-12-2013, 12:14 PM   #12
Joanne S
Senior Member
 
Joanne S's Avatar
 
Join Date: Aug 2007
Location: Detroit Metropolitan Area, Michigan
Posts: 592
Re: Generic Hercpetin coming soon to your cancer center?

Thanks for sharing Joan!
Joanne S is offline   Reply With Quote
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Forum Jump


All times are GMT -7. The time now is 03:21 AM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2024, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007 - 2021
free webpage hit counter