Kalorama: First FDA-Approved Biosimilar Brings Hope for CMO Growth


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 (CMO) industry, according to Kalorama Information. 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.

Biopharmaceutical and Vaccine Production Markets can be found at Kalorama Information: http://www.kaloramainformation.com/redirect.asp?progid=87482&productid=8357580.

Sandoz, Inc.'s Zarxio, approved in March, is biosimilar to Amgen Inc.'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 (API) biologics manufacturing in particular an area of demand.

The FDA believes that biosimilars will provide access to important therapies for patients who need them. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be "biosimilar" to or "interchangeable" with an FDA-licensed biological product, called the "reference product." This abbreviated licensure pathway under section 351(k) of the Public Health Service Act enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.

A biosimilar product can only be approved by the FDA if it has the same mechanism of action, route of administration, dosage form and strength as the reference product, and only for the indications and conditions of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA's standards.

In addition to Sandoz, a number of major drug firms, including Merck, Teva, Dr. Reddy's and Biocon, have indicated interest in pursuing biosimilar drug opportunities. It remains to be seen, of course, if actual revenues generated by biosimilar products will ultimately equal high initial expectations. Manufacturing costs for biopharmaceuticals are considerably higher than those of common oral pharmaceuticals, and the massive discounting seen with the generic introductions of blockbuster patented drug are unlikely. There is concern that originator products will retain the bulk of the market.

Biopharmaceutical and Vaccine Production Markets examines the total biopharmaceutical manufacturing market, including in its estimates all costs related to biopharmaceutical and vaccine production.  It includes the following useful information for business planning:

Market Forecasts and Estimates of Biopharmaceutical Manufacturing Costs
Vaccine Production Estimates
Trend Discussion
Production Methods
The Competitive Environment, including Contract Manufacturing and Outsourcing
Regulation of the Market
Company Profiles

This report also profiles major contract manufacturers, including Lonza AG, Boehringer Ingelheim GmbH, FUJIFILM Diosynth Biotechnologies, Sandoz, Royal DSM, Rentschler Biotechnologie, Celonic, BIOMEVA GmbH, ProBioGen AG and Baxter BioPharma Solutions/Baxter Bioscience.

The report contains production segmentations for the mammalian cell, microbial cell, monoclonal antibody, other recombinant protein, vaccine, and insulin manufacturing markets, with forecasts to 2018. The current competitive environment is noted, listing selected biopharmaceutical contract manufacturers, selected top-selling biopharmaceuticals, selected Asian biomanufacturing contract manufacturing organizations (CMOs), the top 10 biopharma companies based on 2012 biopharma revenues, and the top manufacturers by global biopharmaceutical manufacturing capacity.

Biopharmaceutical and Vaccine Production Markets (Mammalian Cell Production, Microbial Cell Production Market, Monoclonal Antibody Manufacturing, Other Recombinant Protein Manufacturing, Vaccine Manufacturing, Insulin Manufacturing Market) can be found at Kalorama Information: http://www.kaloramainformation.com/redirect.asp?progid=87482&productid=8357580.

About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.  

Bruce Carlson
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SOURCE Kalorama Information