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.