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Contract manufacturing on the rise.

NEW YORK -- The Food and Drag Administration's recent approval of Sandoz' Zarxio (filgrastim), the first biosimilar product approved in the United States, points toward growth in the contract manufacturing organization (CMO) industry, according to Kalorama Information.

The mainstream CMO industry is geared to the production of small-molecule drugs and lacks the infrastructure to produce major biopharmaceutical products. The health care market research publisher's report, titled "Biopharmaceutical and Vaccine Production Markets," found that, though there are uncertainties, a large number of CMOs are positioning themselves to capitalize on the anticipated increase in demand for biomanufacturing.

Zarxio, approved in March, is biosimilar to Amgen Inc.'s Neupogen, which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen and can be prescribed by a health care professional for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.

"The most volatile factor in CMO growth is likely to be the approval and adoption of biosimilar products," said Bruce Carlson, publisher of Kalorama Information.

The FDA believes that biosimilars will provide access to important therapies for patients who need them.

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Title Annotation:RX: RETAIL PHARMACY: Generic Drugs
Publication:Chain Drug Review
Date:Jul 6, 2015
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