Contract manufacturing to get a big boost from biosimilar approvals

NEW YORK - The U.S. Food and Drug Administration's (FDA) recent approval of Zarxio (filgrastim-sndz) - the first biosimilar product approved in the United States - points toward growth in the contract manufacturing organization industry, Kalorama Information reported Friday. The mainstream CMO industry is geared to the production of small-molecular drugs and lacks the infrastructure to produce major biopharmaceutical products. 

 

The healthcare market research publisher's report, "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 the demand for biomanufacturing.

 

Sandoz' Zarxio, approved in March, is biosimilar to Amgen's Neupogen (filgrastim), 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. "If these biologic generics deliver on the promise of massive cost savings for extremely expensive biopharmaceuticals, growth of biosimilars will spur dramatic growth in contract manufacturing production capacity. "  

 

Further the report says that since many biosimilar developers cannot lay claim to their own biomanufacturing facilities – and that a significant number of follow-on versions are successful for each current successful product – we can expect that the CMO market will profit from biosimilars development, with active pharmaceutical ingredients biologics manufacturing in particular an area of demand.