For First Time, F.D.A. Panel Approves Generic Copy of Costly Biologic Drug

Source: New York Times

9 Jan 2015

SILVER SPRING, Md. — An expert panel unanimously recommended on Wednesday that the Food and Drug Administration approve a cheaper copy of a special drug used in cancer therapy, paving the way for alternatives to an entire class of complex and costly drugs to enter the United States market.

Most brand-name drugs eventually lose their patent protection, opening the market to lower-priced generic products. But one class of drugs, known as biologics, which includes some of the most expensive medications in the world, has been insulated from the competition of cheaper copies for years.

That changed when the 14 members of the panel, convened by the F.D.A., agreed to recommend approval of a drug known as EP2006, which helps the body make white blood cells and is a close copy of an existing medication called Neupogen, also called filgrastim. EP2006 was approved in Europe in 2009 as Zarzio but has not been used in the United States, in part because no regulatory pathway existed to bring copies of biologic drugs to market.

A lower-cost version of the Amgen biologic drug Neupogen, used in cancer treatment, could open the door to more such biosimilar medicines. Credit Amgen

“This is kind of like cutting the ribbon to open a major new road,” said Ronny Gal, a senior research analyst who focuses on specialtypharmaceuticals at Sanford C. Bernstein & Company. “It is literally a new concept in medicine.”

Biologic drugs are so called because they are made out of living cells and not synthesized from chemicals as ordinary drugs are. Some examples of popular biologic drugs areRemicade, Humira and Enbrel for autoimmune disease, and Herceptin, Rituxan and Avastin for cancer.

If the F.D.A. follows the panel’s advice — it usually does, though it does not have to — the move would usher in an era of competition for biologics and would eventually reduce prices, Mr. Gal said. Pharmaceutical companies have been criticized recently for the high prices of new drugs, and biologics are particularly expensive; Avastin, for example, can cost more than $50,000 a year.

Express Scripts, the nation’s largest manager of prescription drug benefits, estimates that the introduction of EP2006 — to be called Zarxio in the United States — could save $5.7 billion in drug costs over the next 10 years.

“The need to bring low-cost competition into biologic drugs is critical in making American health care more affordable,” Mr. Gal said. Biologics make up about a third of drugs in the United States, he said, and the share is expected to grow.

The drug recommended on Wednesday is made by Sandoz, a unit of the Swiss company Novartis. Neupogen, the original, is made by Amgen, an American company.

Biologic drugs were first developed in the 1980s and were considered so specialized that making generic versions was seen as most likely impossible. But science has advanced, and as patents began to expire, drug companies started developing close copies, called biosimilars, and seeking F.D.A. approval for them. Companies with the original patents initially resisted, arguing that their drugs were so complex that it was not possible to make an exact copy, but that position eventually became untenable.

Biosimilars are about a third cheaper than brand-name biologic drugs, on average, in countries where they are in use, according to Express Scripts, although some argue the discounts could be much steeper, up to 90 percent.

Express Scripts estimated that $250 billion in drug costs could be saved over the next decade if 11 biosimilars in development were approved.

At the meeting on Wednesday, experts seemed to be following the thinking of F.D.A. officials, several of whom stated directly that the drug maker had achieved its goal.

“The data submitted by Sandoz demonstrated that EP2006 is highly similar to U.S.-licensed Neupogen, and that there are no clinically meaningful differences between the two products,” said Dr. Albert Deisseroth, medical officer team leader for the Division of Hematology Products at the F.D.A.

Experts voted to recommend approval for all five of Neupogen’s licensed uses — known in medical terms as its indications. That is a victory for Sandoz, and a positive signal for makers of biosimilars, who had worried that approval might only cover a few uses.

The F.D.A. is not allowed to consider the price of drugs in its approvals, but even so, a series of outside speakers, including patients, urged approval to make critical treatments more affordable.

“We have talked this morning about the elephant in the room — about cost,” said Amye Leong, who identified herself as a patient. “I know that the F.D.A. is not supposed to be talking about this, but it is the cost that we patients daily must deal with.”

The meeting drew intense interest in the pharmaceutical industry and included prominent speakers like Dr. Janet Woodcock, the director of the agency’s Center for Drug Evaluation and Research, who spoke about the new regulatory pathway for biosimilars. The blueprint was laid out in 2010 in the Affordable Care Act, and the F.D.A. has issued guidance for companies on how to gain approval for biosimilars.

This entry was posted in Biologics/Biosimilars, Generics, Patents. Bookmark the permalink.

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