HER2 Support Group Forums - View Single Post - Generic Hercpetin coming soon to your cancer center?

Joan M · 02-11-2013, 07:43 PM

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

02-11-2013, 07:43 PM	#11
Joan M Senior Member 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..