FDA accepts Sandoz biosimilar application

US officials have accepted an application by Novartis to market a biosimilar of Amgen’s Neupogen (filgrastim) drug, a move thought to be the first of its kind.

The Food and Drug Administration (FDA) accepted the filing by Novartis generics arm Sandoz to market its own version of the drug, used to treat patients with low numbers of white blood cells.

It is thought to be the first accepted application to market a biosimilar since the US introduced laws to enable them.

Biosimilars are similar to generic drugs but are biopharmaceutical products only. The system for allowing them in the US was created by the Biologics Price Competition and Innovation Act, implemented in March 2010.

But, according to the PatentDocs website, although Sandoz claimed its application was the first to be accepted by the FDA, it is not possible to be certain because the information is not made publicly available by the organisation.

Amgen, known as the reference product sponsor, and Sandoz will be required to enter into a series of exchanges after acceptance to determine which patents will involve litigation.

“It is only after this process is concluded that a lawsuit can be filed by the reference product sponsor,” the website said.

“This process can take on the order of half a year. Therefore, we might not know for sure whether the filgrastim application is the first such application until sometime early next year”.

Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz, said the filing acceptance represented a “significant step” towards making “high-quality biologics more accessible” in the US.

“We applaud FDA for its progress in making this a reality,” McCamish added.

Sandoz already sells a biosimilar version of the drug under the name Zarzio in more than 40 other countries.