Zarxio is a copy of Neupogen, a drug made by Amgen which was approved in Europe under the name of Zarzio. The drug has not been used in the US because there were no regulatory pathway to bring biosimilar drugs to market. The approval of Zarxio introduces a class of new lifesaving drugs, which are a cheaper alternative for millions of Americans. The new class consists of biologic drugs, made not using cells synthesized from chemicals, but living cells. Some popular drugs of this kind are Enbrel and Remicade, used for autoimmune diseases and drugs such as Avastin and Herceptin used for cancer.
So far biologic copied have been isolated from the market of cheap copies. This is the first time a low-price alternative has received approval. This will lead to lower prices of old cancer drugs and will make space for new cancer drugs. Biologic drugs first appeared in 1980 and generic versions of them could not be conceived at that time because biologics were too specialized. But in time companies were able to develop close copies. This is owing to the fact that science has developed and patents expired.
The head of biopharmaceuticals and oncology injectables at Sandoz, Carol Lynch, thinks that FDA’s approval for this drug is a milestone for the health care system of the US. Biologic drugs usually have very high prices. Dr. John K. Jenkins, who is director of the Office of New Drugs in F.D.A.’s Center for Drug Evaluation and Research, believes that competition will lead to the price lowering of such products and so make them more affordable for people who need them.
Express Scripts, the nation’s largest manager of prescription drug benefits, stated that the price of biosimilar drugs is three times lower than the price of brand-name biologic drugs. Express Scripts also said that Zarxio could save $5.7 billion in the cost of drugs over the 10 years. If the 11 biologic drugs that are now in development will be approved, it will save up to $250 billion. Yet, there are is no information about the price of the product.
There has been a debate over how biosimilars should be named. Some are of the opinion that they should have the same name as the branded product because this way it will be easier to use them as substitutes. On the other hand, biologics makers consider the names should be different because in case of side effects, it would be easier to distinguish.
Regarding that matter FDA took a decision which did not make Sandoz glad. Zarxio was not called with the same name as the generic Neupogen (filgrastim). It was instead called filgrastim-sndz. Another debate was whether biosimilars are more brandlike or rather genericlike. Officialsof FDA. According to Mr. Gral, this matter “threads the needle”.
Image Source: IB Times