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Pallone Applauds FDA Approval of First Biosimilar Medicine

Mar 6, 2015
Press Release

“This is great news because it shows that the biosimilars approval process is working,” said Congressman Pallone.  “Zarxio has been found to be safe and effective and should provide competition and lower costs to this class of biotech drug.  It has taken a long time to reach this point, but this is undoubtedly a good day for both patients and our health care system as a whole.” 

Biologics are drugs derived from living organisms.  A biosimilar product is one that is determined to be highly similar to an already-approved biological product and is as safe and effective as the brand version. They are comparable to generic drugs, which are determined to be as safe and effective as their brand version.  Biosimilars are generally more difficult to develop than traditional generic drugs because they are larger, more complicated molecules.  Therefore, they may end up being priced closer to their brand counterparts than are traditional generic drugs.  However, because biologics tend to be expensive, even relatively small discounts may result in large savings.

Generics have saved consumers and the U.S. health care system $239 billion in 2013 and have saved the U.S. nearly $1.5 trillion between 2004 and 2013, according to a report by the Generic Pharmaceutical Association.  Today, generics also fill 80% of prescriptions, while consuming just 26% of drug spending.