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 이성욱 ( 2015-03-11 14:20:55 , Hit : 996
 First U.S. biosimilar is not considered interchangeable

FDA Approves First Biosimilar Ushering in a New Era of Treatments

12:08 pm ET
Mar 6, 2015
Ed Silverman
After years of anticipation, the FDA has approved a so-called biosimilar medicine, ushering in a new era of treatments in the U.S. that are

—Getty Images/Fotosearch RF
forecast to eventually save the nation’s health care system billions of dollars and generate a new round of competition in the pharmaceutical industry. Biosimilars are cheaper copies of brand-name biologics that have demonstrated similar safety and effectiveness.

The biosimilar approved by the FDA is a version of Neupogen, a $5.7 billion drug sold by Amgen AMGN -0.92% that is used to thwart infections during chemotherapy. The copycat version will be sold by the Sandoz unit of Novartis NVS -1.83% and marketed as Zarxio. However, the Sandoz drug is not considered interchangeable, which means it cannot automatically be substituted at pharmacies.

The landmark approval comes five years after the Biologics Price Competition and Innovation Act became law as part of the Affordable Care Act and provided a pathway for the FDA to review applications from drug makers to sell biosimilars. These medicines, however, have been available in Europe and many other countries for several years.

“Biosimilars will provide access to important therapies for patients who need them,” FDA Commissioner Margaret Hamburg says in a statement announcing the approval. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”

The move was quickly praised by one big payer. Express Scripts, the largest pharmacy benefits manager in the U.S., forecasts the Sandoz drug will save the health care system $5.7 billion over the next decade, assuming a 30% discount off the current price for Neupogen, which sells for about $3,500 for a 30-day supply. A Novartis spokeswoman did not respond to a question about pricing.

A point worth noting is the labeling for the Sandoz drug is fairly similar to the label for the brand-name biologic, according to Sanford Bernstein analyst Ronny Gal. There had been questions whether the label would emphasize Neupogen trial data or proof of similarity. This “suggests more rapid penetration of biosimilars and market development [that is] more along generic lines,” he writes in an investor note.

Still, some questions remain. The FDA has not yet offered guidance for determining interchangeability, which may dampen sales. Meanwhile, 25% of payers are reluctant to recommend switching an existing patient to a biosimilar and nearly one-third of physicians say they are unlikely to switch existing patients, according to the Tufts Center for the Study of Drug Development, which is partially funded by industry.

Nonetheless, the approval was greeted enthusiastically by Novartis, whose Sandoz unit is one of the world’s largest purveyors of generic drugs and already markets biosimilars in other countries. Amgen, however, did not have much to say about the approval itself, but this likely reflects ongoing litigation with Sandoz over its bid to sell a biosimilar version of Neupogen in the U.S.

The drug makers have been battling in court over the extent to which one company must provide another with detailed information about its plans for pursuing a biosimilar. The row has been closely watched for how brand-name and generic drug makers are required to resolve clashes over patent rights whenever biosimilar applications filed with the FDA. A hearing is set for next week. [UPDATE: Sandoz will not launch its drug until a federal court issues a decision regarding an Amgen request for a preliminary injunction, or until April 10, whichever is earlier- see this].

Amgen did appear pleased about one point. The FDA decided, for now, the Sandoz biosimilar will have a different International Non-Proprietary Name, or INN, than the brand-name Amgen biologic. In the medical community, health care providers often refer to the INN, or chemical name for a medicine, rather than the commercially known name, when discussing treatments.

Biosimilar naming is a controversial topic. At issue is the extent to which a different INN for a biosimilar would hamper substitution or compromise patient safety. Brand-name drug makers want biosimilars to have unique names and argue this would make it easier to track adverse events in patient records and side effect reports filed with regulators.

Generic drug makers say different names may confuse physicians and pharmacists, who may have difficulty sorting out whether medicines are really the same as they try to verify dosing and regimens. As they see it, brand-name drug makers are trying to thwart substitution.

The FDA has not set a formal policy, but noted that since the INN for Neupogen is filgrastim, the FDA says the Sandoz version for now should be called filgrastim-sndz. The generic industry trade group called this decision disruptive, while Amgen called it “an important first step” in creating “transparency and accountability.”

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