Biosimilars Gain Traction

One year after the biosimilar version of Zarxio, manufactured by Novartis and a competitor of Amgen’s drug Neupogen, landed on the market, the US Food and Drug Administration (FDA) has approved a second biosimilar drug. (Neupogen is used to treat neutropenia, lack of certain white blood cells caused by cancer, bone marrow transplant, or chemotherapy).

In early April, the FDA approved a biosimilar called Inflectra, by Celltrion (Incheon, South Korea, with marketing by Pfizer) that works in a way highly similar to that of Johnson & Johnson’s Janssen Biotch drug Remicade or infliximab, which treats autoimmune diseases like Crohn’s disease and rheumatoid arthritis, Business Insider reported. The drug is based on a monoclonal antibody and has a more complex biochemical structure than Zarxio.

Hospira Inc. (acquired by Pfizer last year) has an application before the FDA for a biosimilar that would compete with Amgen’s Epogen and J&J’s Procrit. These drugs are used to treat anemia in patients with chronic kidney disease who are on dialysis.

While Celltrion was pleased to announce the approval, Morningstar analyst Damien Conover said the branded Johnson & Johnson drug could lose half its sales by 2020, according to Reuters.

Biologic drugs are made from living cells and involve highly complex manufacturing processes. Biosimilar drugs are created to be similar to a biologic drug already approved by the FDA (the reference drug) and must be shown to be highly similar.

Congress has allowed biopharmaceutical innovators making the reference drugs 12 years of data protection to keep the market in balance, phrma.org reported, so that the market will not fill with a fleet of new, cheaper biosimilar medications that might discourage producers of reference drugs from pursuing innovation and creating original drugs through expensive development work.

In its first 4 months on the market, Zarxio was a factor in reducing Amgen’s share of the market to 76 percent, wrote Biopharma-Reporter.com, a website that follows biopharmaceutical news. “Zarxio was launched at a 15% discount to its reference product,” and was used by patients on dialysis as well as many others.