FDA lays guidelines for “biosimilar” biotech drugs

Published on February 12, 2012 at 5:41 PM · No Comments

By Dr Ananya Mandal, MD

The Food and Drug Administration (FDA) has come up with guidelines for the sale of lower-cost versions of biotechnology drugs.

The proposed rules, issued on Thursday, require studies showing that the generic copies are “highly similar” to the originals, but there are several ways that might be proven. Because of their complexity, generic copies of biotech drugs - first introduced in the 1980s - are known as “biosimilars.” The worldwide market for copies of biotech medicines will grow to $3.7 billion by 2015, from just $243 million in 2010, as more than 30 branded biologics with sales of $51 billion lose patent exclusivity, according to market analysis firm Datamonitor.

Since their introduction in the 1980s, biotech drugs have never faced generic competition because the FDA did not have power to approve copies of such medications. For years the biotech industry 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.

“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 drug division director Dr. Janet Woodcock said in a statement.

“We're trying to send the signal that it's not one-size-fits-all. It's product-by-product,” Rachel Sherman, director of the FDA's office of medical policy, said during a conference call with reporters. The FDA rules would set “an abbreviated pathway” to approval that would consider factors including a product's complexity, formulation and stability, the agency said.

“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 Sherman. She said the FDA has not yet received any applications for biosimilars drugs, though companies have submitted three dozen requests for meetings on potential products.

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