The US Food and Drug Administration (FDA) have approved the first non-brand name version of a biological drug called Zarxio. This drug facilitates patients to raise the level white blood cells after these cells have been obliterated by chemotherapy.
Zarxio is a manufacturer by Sandoz and this drug is a cheaper replica or biosimilar version of Amgen’s biologic drug Neupogen. In 1991, the FDA had approved the manufacturing of Neupogen, commonly acknowledged as Filgratism.
There is no question of the noteworthy advances that biological drugs have brought in the table for medical sciences and it is apparent from the revolution of cancer care and other diseases such as juvenile arthritis. The major issue even with all the advancements is the high cost that comes with it. This is ‘a first for FDA’ to approve a non-brand name company to manufacture such drugs.
Dr. Margaret A. Hamburg, FDA commissioner has stated in press release that biosimilars are guaranteed to ensure that patients who require important therapies are able to access it. A new procedure for approval is something that FDA should dig deeper into when it comes to biosimilar drugs.
The organization was under legal pressure, which is part of the Affordable Care Act, for making bio-similar drugs accessible as they are much more inexpensive in comparison to the brand-name ones.
Carol Lynch, the global head of biopharmaceuticals and oncology injectables at Sandoz, said in a press statement, “As the global leader in biosimilars, we are honored to be the first company to successfully work with the FDA to navigate the U. S. biosimilar pathway, and we look forward to making this high-quality biosimilar available to patients in the U.S.”
FDA measures biosimilar drugs side by side with the original drug and they must prove that the drugs have same indications, mechanisms and dosages. Manufacturers of biosimilars are also required to verify that the facilities used for producing the biosimilars are also identical with the FDA standards.