First Biosimilar Poised For FDA Approval

Patients and payers have been anxiously awaiting approval of the first “biosimilar” medicines in the United States, hoping the new biologics will lower the cost of these often lifesaving treatments.

But early statements from makers of the first of these drugs likely to reach the market indicate that the company expects to launch its biosimilar at parity with the brand-name drug, a decision which would disappoint patients, policymakers, and payers, including Medicare.

The FDA is expected to soon approve Zarxio, a drug that is biologically similar to Amgen’s Neupogen which is injected as part of the treatment for cancer patients receiving chemotherapy, for patients with abnormally low counts of white blood cells, and other indications.

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