Biosimilar Drugs – What is it? and What’s Next?

The age of biosimilar drugs has arrived. Almost five years into the Patient Protection and Affordable Care Act, FDA approved the first biosimilar drug – Zarxio (Filgrastim-SNDZ) by Sandoz Inc. of Novartis. Zarxio is prescription drug, in injectable dosage form.

Zarxio, a biosimilar to Neupogen, is a medication that boosts the production of white blood cells and helps to ward off infection in patients receiving strong chemotherapy for some tumors, or patients undergoing bone marrow transplantation or patients with chronic neutropenia.


A biosimilar product is a biological product that is “highly similar” to an already-approved biological product (reference product) approved by FDA. The biosimilar must have the same strength and dosage form. From a consumer standpoint, with Biosimilars, more treatment options are available and also potentially lowering costs as well.

For more details, refer to this link.

Under the Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, lends way to create abbreviated licensure pathway for biological products that demonstrated to be “biosimilar” or “interchangeable” with an FDA-licensed biological product. This pathway is part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act), under which a biological product that demonstrated to be “biosimilar”, that is, a product “highly similar” to an already-approved biological product.

What’s Next?

There is more in the offing. With amendments to Public Health Service Act (PHS Act), a new door has opened for launching more and more biosimilar or “interchangeable” drugs. Of course, each of these drugs would go through a rigorous process standards set by FDA for drug safety and efficacy.

In 2012, the rise of biologics reshaped the drug market. Now, with first biosimilar drug in the market, more biosimilar drugs are likely to follow in transforming the landscape that has mostly seen traditional drugs and biologics drugs till now.

Does the arrival of biosimilars sound trouble for biological drugs. The obvious answer is ‘yes’, but it would not be so hard as the generic versions coming into the market.