FDA outlines path for lower-priced biotech drugs

February 9, 2012 By MATTHEW PERRONE , AP Health Writer

(AP) -- The Food and Drug Administration is preparing to review the first lower-cost versions of biotech drugs, expensive medications which have never before faced generic competition.

The guidelines issued by the FDA on Thursday are the final step in a decades-long effort to lower the price of , high-tech injectable medications that cost the nation billions of dollars each year.

"These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers," FDA's division director Dr. Janet Woodcock said in a statement.

Since their introduction in the 1980s, biotech drugs have never faced because the FDA did not have power to approve copies of such medications. For years the successfully argued that their drugs, often made from living cells, were too complex to be duplicated by competitors.

That finally changed with the Obama administration's 2010 health overhaul, which ordered the FDA to create a system for approving so-called "biosimilar drugs." The industry term arose because biotech scientists insisted it would be impossible to produce exact copies of their biologically engineered drugs. They differ from traditional drugs, which are made by combining various chemicals.

Health care data firm IMS Health estimates the global market for biosimilars will range anywhere from $11 billion to $25 billion by 2020, accounting for 4 to 10 percent of the total market for biotech drugs. The estimated biosimilars would save the government $25 billion in reduced in the coming decade.

The FDA's , posted online, reflect a final agreement that was largely shaped by the biotech industry's demands. As a result, new biotech drugs will enjoy a 12-year period of exclusive, competition-free marketing before a rival medication can launch. Additionally, companies seeking to market biosimilars will have to submit extensive chemical and biological testing data to show that their products function similarly to the originals. The FDA will also have the option to require human and animal clinical studies, the most expensive forms of testing, though staffers said the requirement would be used only when necessary.

"We do not want companies repeating studies that do not need to be done - that wastes precious resources, and of course, exposing humans and animals to unnecessary testing is unethical" said Dr. Rachel Sherman of FDA's office of medical policy. Sherman said the FDA has not yet received any applications for biosimilars drugs, though companies have submitted three dozen requests for meetings on potential products.

The agency will require human testing to declare a biosimilar "interchangeable," with the original drug, a key point of contention between branded drugmakers and their would-be competitors. Such a designation would allow health care professionals to switch patients to a generic version, significantly curbing sales of the original products.

Examples of biotech drugs include specialty cancer drugs like Roche's Avastin, which costs more than $100,000 for a year's supply, and the diabetes staple insulin, which costs closer to $1,000 per year.

Analysts disagree over how much of a discount biosimilars will provide in the U.S. In Europe, where biosimilars have been on the market for several years, knock-off versions of biotech drugs are generally about 20 to 30 percent cheaper than the original products. Companies marketing biosimilars in Europe include Novartis division Sandoz International, Hospira Inc. and Teva Pharmaceutical Industries Ltd. Several U.S.-based brand-name drugmakers have also announced plans to develop biosimilars, including Merck & Co. Inc. and Pfizer Inc.

The FDA said it would take comments on its guidelines for 60 days before finalizing them.

Explore further: FDA approves first generic versions of Zyprexa

shares

Related Stories

FDA approves first generic versions of Zyprexa

October 24, 2011
(AP) -- Federal health officials on Monday approved the first generic versions of the blockbuster drug Zyprexa, an expensive treatment for schizophrenia and bipolar mood disorder.

FDA panel backs Pfizer drug for kidney cancer

December 7, 2011
(AP) -- A panel of advisers to the Food and Drug Administration voted Wednesday that the benefits of a Pfizer kidney cancer drug outweigh its risks, according to a company spokeswoman.

Recommended for you

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

Price tag on gene therapy for rare form of blindness: $850K

January 3, 2018
A first-of-its kind genetic treatment for blindness will cost $850,000 per patient, making it one of the most expensive medicines in the world and raising questions about the affordability of a coming wave of similar gene-targeting ...

Restasis: Why US consumers paid billions for drug deemed ineffective in other countries

January 2, 2018
Why are Americans, both as patients and taxpayers, paying billions of dollars for a drug whose efficacy is so questionable that it's not approved in the European Union, Australia or New Zealand? Restasis, a blockbuster drug ...

1 comment

Adjust slider to filter visible comments by rank

Display comments: newest first

Jesse_EngAmer
not rated yet Feb 09, 2012
This is rather hypocritical of the FDA considering it is additional FDA testing that so often forces the cost of drugs up. FDA overregulation looking to solve FDA overregulation. Read it for yourself, let me know what you think:http://www.fdarev...rm.shtml

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.