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Are Biosimilars the New Generics?

Maybe soon. What exactly is a biosimilar drug and what makes it like a generic? Where do you find biosimilar drugs? Are they like biologics?

Biologics are specialty drugs available in the United States to treat a variety of conditions from anemia to multiple sclerosis to rheumatoid arthritis. These medicines make up a small but increasingly costly part of the U.S. drug market. Biologics are so expensive that they are often out of reach for many individuals. As an example, a biologic used to treat rheumatoid arthritis can cost at least $1800 a month.

Biosimilars were created to compete with biologics to reduce the cost. They are a little like generic drugs. The key difference between the two lies in the manner in which they are developed. Biosimilars are meant to replicate biologics which are made with living cells. It is difficult to make exact copies of biologics because they are manufactured differently than tablets or syrups.

Biosimilar drugs have been on the market in Europe for almost ten years and this has led to a price reduction of twenty to thirty percent for some biologics. Could this happen in the United States in the near future?

Yes.  The Affordable Care Act has established provisions for the development of biosimilar drugs in the United States. The Biologics Price Competition and Innovation Act is a forty page section of the Affordable Care Act that establishes the framework for the FDA to assess and approve biosimilars. Similar legislation was passed in the 1980’s that paved the way for the approval of generic drugs.

The standard for FDA approval of biosimilar drugs is a higher standard than what is required for traditional generics. The FDA has just approved its first biosimilar drug, brand name Zarxio, which is similar but not quite identical to Amgen’s Neupogen, a drug that received FDA approval in 1991 to be used to fight infections in cancer patients. Unlike other biosimilars scheduled for approval review, Zarxio has been used in Europe for years and had a significant amount of data to support its use, making the approval process easier.

For additional information, contact EAB HealthWorks.