Until recently, serious ailments like arthritis or cancer could only be treated with expensive medicine, but that is about to change. On Friday, the first biosimilar received approval in the U.S., a cheaper version of Amgen’s Neupogen.
Pharmaceutical and biotechnology companies have been manufacturing complex and expensive drugs with no cheaper alternatives for years. But thanks to a law passed in 2010, that will soon no longer be the case. The Food and Drug Administration (FDA) approved on Friday the first-ever replica of a bio-engineered drug, under the name of Zarxio.
Julie Masow, a spokeswoman for Novartis, the company that will be producing it, announced that they agreed to postpone the selling of the drug in the U.S. until the lawsuit with Amgen reaches a conclusion, or until April 10, whichever comes first.
Last year sales show a high figure of $1.2 billion for Neupogen, used as therapy for fighting infections and increasing white blood cells in cancer patients. The drug falls under the biologics category of medicines, a group that hasn’t dealt with generic competition until now.
According to the 2010 Patient Protection and Affordable Care Act, FDA has now officially approved imitations of biologics. The term “biosimilars” is preferred to generics, because medicine from the biologics group cannot be exactly replicated, as they are manufactured from living organisms.
Unlike traditional generic drugs, biosimilars aren’t expected to cut down prices by 80 percent. Last November, Rand Corp. estimated that over 10 years, biosimilars will save up to $44 billion. As noticed by Louis Weiner, director of the Lombardi Comprehensive Cancer Center and head of the department of oncology at Georgetown University, the use of Neupogen has mostly been reduced because of the price. That’s why the authorization for biosimilars has the opportunity of reducing costs to the healthcare system and increase access among the U.S. population.
There are other companies which applied for FDA approval besides Novartis. Apotex, for example, created an upgraded version of Neupogen called Neulasta. Hospira Inc. also has developed a biosimilar pending approval before the FDA, a drug that will benefit patients on dialysis who battle anemia due to chronic kidney disease.
Express Scripts Holding, the biggest pharmacy benefit manager in the U.S, has estimated that Zarxio could save the U.S. health-care system up to $5.7 billion in the next decade, at a price at least 30 percent cheaper than Neupogen.
The FDA approval for Zarxio covers all five conditions related to white blood cell counts that Neupogen is currently treating. Masow, the company’s spokeswoman, declined to reveal any information related to pricing until Zarxio hits the shelves.
Another question that FDA needs to answer is the issue of the drugs’ name. A universal name usually helps pharmacies, health insurers, and most importantly, doctors to identify a specific drug, and it also affects the way treatments are perceived by the population. For example, all generic copies of Pfizer Inc.’s Lipitor must have the name of the active ingredient atorvastatin.
In the case of biosimilars, there is a dilemma over whether or not their differences should receive some kind of qualifier, separating them from their brand-name counterparts. John Jenkins, head of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research said that, until the FDA comes up with a polished naming policy, they will follow the active-ingredient method. Therefore, the FDA called Zarxio filgrastim-sndz, after the active ingredient in Neupogen, filgrastim.
European authorities do not require different names for biosimilars, and Novartis argues that they should follow suit, as a strange name could make both doctors and patients reluctant to use said drug. According to the European Medicines Agency, Zarxio has been approved by the European Union back in 2009, being the last Sof eight to receive authorization as a filgrastims biosimilar.
Novartis’s biosimilar received unanimously approval on January 7 from an FDA advisory panel of outside experts. The next one down the line is a more complex biosimilar, Celltrion’s version of J&J’s Remicade, which was set to come before the FDA on March 17. The agency was forced to postpone the meeting, as it still awaits the fulfilling of some information requests with Celltrion. Remicade the original is part of the antibody class of drugs, and it’s used in some of the best-selling cancer treatments. A Bloomberg report showed that, in 2014, the drug generated $6.9 billion in sales.
Because there are no official guidelines for how a company can prove interchangeability of drugs, Novartis did not apply for Zarxio to be interchangeable with Neupogen. Such an authorization would have permitted it to be legally substituted at the pharmacy. But as it is, before a patient is given Zarxio (or any other biosimilar approved in the future), a doctor must give his accord.
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