First Biologic Biosimilar Accepted for Review by FDA

The FDA has accepted an application by Sandoz, the generic branch of Novartis, for approval on a biosimilar version of Amgen’s filgrastim. Filgrastim is used to reduce the rate of infections in cancer patients undergoing chemotherapy, which often leads to a lack of white blood cells, giving rise to a condition known as neutropenia.

This acceptance for review by the FDA is a landmark in the rollout of cheaper versions of injectable biotechnology medications. Sandoz noted that this is a necessary step in increasing patient access to expensive treatments.

Sandoz already sells a biosimilar version of filgrastim (Zarzio^®) in more than 40 other countries around the world; however, the United States has been slow to establish a regulatory framework for biosimilars. Sandoz currently markets 3 biosimilars outside the United States, each of which are the top biosimilar in its respective category.

Because biotechnology drugs are made from living cells, it is impossible to manufacture exact copies, so regulators have had to devise approval processes for products that are similar enough to do the job.

Sandoz is the global leader in biosimilars, with a market share of >50%.—Kerri Fitzgerald

Source: Thomson Reuters. 2014; U.S. paves way for Novartis to copy Amgen biotech drug.