Health Care | Novartis Zarxio | 2015

On March 6, 2015, The United States FDA announced that it approved the first biological product in the United States.

Novartis Zarixo: Miracle Drug or Hopeful Wishing!

This product is called “Zarxio”.  Zarixo was made by Sandoz, Inc. a Novartis company, based in Princeton, New Jersey, USA. The United States Food and Drug Administration announced that it approved the first biological product in the United States on March 6, 2015. Zarxio is a “Biosimilars” product, which means, it is a complex biological medicine that is made of living organism vs synthetic chemical. The biosimilar organism can originate from humans, animals, and microorganisms, and therefore this product can be easier adapted by the human body. This product is aimed to treat patients with rheumatoid arthritis, anemia, low white blood cell count, IBS, and various forms of cancer. However, just like any other drug, this product causes different side effects in each patient. The most common side effects are aching of bones and muscles tissue swelling around the mouth, eyes, and shortness of breath. Since this product is injected, it can cause swelling and itching of injected site. The FDA has not issued draft guidance on how the drug can be marketed. FDA shall do so in the near future. Will this drug be the miracle drug to heal terminally ill cancer patients; yet, that is still to be seen!

What is BPCI Act?

The acronym BPCI stands for Biologic Price Competition and Innovation Act of 2009, (BPCI Act). The BPCI Act is vital in the process of approving biosimilars. The Patient Protection and Affordable Care Act (PPAC Act), was signed into law by President Barak Hussein Obama on March 23, 2010. Based on the FDAs Guidance, Compliance and Regulatory Information:

“This amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) the or ‘interchangeable’ with and FDA-approved biological product.”

How does BPCI Act affect Biosimilars?

Under the Biologic Price Competition and Innovation Act of 2009,

“…a biological product has been approved as an ‘interchangeable’ may be substituted for the reference product without the intervention of the health care provider who prescribed the referenced product.”

This product has been sold in Europe under the name of “Zarxio”, a low-cost version of an expensive drug. Norvartis’s Zarxio can be an economic and life changing experience for all patients living in the United States.