First Biosimilar Gets FDA Staff Nod as Amgen Drug Draws Imitator

(Bloomberg) — The first attempt in the U.S. to bring to market cheaper imitations of expensive biologic drugs gained support from U.S. regulators.

Novartis AG’s imitation, or biosimilar, is “highly similar” to Amgen Inc.’s blockbuster cancer medicine Neupogen, Food and Drug Administration staff said today in a report. FDA advisers will consider the report when they meet Jan. 7 to make a recommendation on whether the biosimilar should be approved for all five conditions Neupogen is sold to treat, most which help increase the white cell blood count of cancer patients.

Neupogen, which generated an estimated $1.2 billion in sales for Amgen in 2014, is part of the growing class of biologic medicines, which are more complex than chemical drugs. They also are typically more expensive and, unlike chemical drugs, have never faced generic competition before. The U.S. may save at least $44 billion in drug spending in the next 10 years by introducing biosimilars, according to Rand Corp.

FDA staff said Novartis’s data suggest the biosimilar should be approved for all five conditions. The report said there is some data pending that may be available for the adviser meeting.

Novartis’ biosimilar version of Neupogen “meets the requirement for a demonstration of ‘no clinically meaningful differences’ between the proposed product and the reference product in terms of safety, purity, and potency,” FDA workers said.

Neupogen Comparison

Novartis compared its biosimilar to Neupogen approved in the European Union in some studies and was able to prove that the drug is also similar to the U.S. version, FDA staff said. The company’s biosimilar does have a “slightly lower protein content” than Neupogen approved in the U.S., which may be resolved by manufacturing changes, the report says.

Biologic drugs are more complex than chemical drugs because they are made from living organisms. For example, Pfizer Inc.’s cholesterol-lowering Lipitor is a chemical drug made from a powder called atorvastatin that’s readily available in generic form. Neupogen is an amino acid protein produced using technology that combines DNA molecules in a host organism, which in this case is E. coli.

Chemical drugs have faced generic competition for more than three decades. The FDA only gained the power to approve a biosimilar in the 2010 Patient Protection and Affordable Care Act, also known as Obamacare. Imitation biologic drugs are called biosimilars instead of generics because living organisms can’t be precisely copied. Chemical generics are typically approved without clinical trials as long as manufacturers show a drug will work the same as the brand-name version it copies. Biosimilars will require some clinical trials.

European Approval

European regulators began approving biosimilar products in 2006 and cleared imitations of Neupogen for sale in 2008. Novartis sells the biosimilar under the name Zarzio in Europe.

Generic chemical drugs saved the U.S. almost $1.5 trillion from 2004 to 2013, according to the Generic Pharmaceutical Association, a Washington-based lobby group for the industry.

Biosimilars blur the line between what are considered name- brand drugmakers and generic manufacturers. Basel, Switzerland- based Novartis, which develops medicines like anti-cancer treatment Gleevec, has a generic drug unit that will make the biosimilar for Neupogen. In addition to introducing drugs like Neupogen, Thousand Oaks, California-based Amgen is working on biosimilars of its own, including an experimental version of AbbVie Inc.’s best-seller, the psoriasis drug Humira.

More Coming

The FDA has other biosimilars coming up for approval. Celltrion Inc., a South Korea-based generic-drug company, filed an application in August for an imitation of Johnson & Johnson’s arthritis treatment Remicade. Apotex Inc. said in December it filed for FDA approval of a biosimilar version of Amgen’s cancer medicine Neulasta.

The FDA had approved some imitations of biologic drugs before the agency established the abbreviated biosimilar pathway, meaning those treatments aren’t considered true biosimilars. The first was Novartis’s Omnitrope in 2006, which imitates Pfizer Inc.’s human growth hormone Genotropin. In 2012, the FDA also approved Teva Pharmaceutical Industries Ltd.’s version of Neupogen.

Getting approval doesn’t guarantee success. Novartis and Teva struggled to gain market share even though their drugs were 30 percent to 40 percent cheaper than their brand-name counterparts, according to Bloomberg Intelligence analyst Asthika Goonewardene.

That may partially be the result of some policies on biosimilars that haven’t yet gotten a ruling from the FDA. The agency hasn’t issued guidelines on whether biosimilars will be called by the active ingredient in the brand-name version, like chemical generics are. And the FDA hasn’t said how to design studies that prove the imitations can be safely swapped with the originals. FDA workers said in the report they were referring to Novartis’s biosimilar as EP2006 because they are still considering what to call the imitator drugs.

To contact the reporter on this story: Anna Edney in Washington at [e-mail] To contact the editors responsible for this story: Crayton Harrison at [e-mail] Bruce Rule