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

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.

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

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

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.

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

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?

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???

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

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.

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

Re: Generic Hercpetin coming soon to your cancer center?
 

Thanks for sharing Joan!