Novation supports the approval of tbo-filgrastim in the US

September 7, 2012 8:06 AM

After the approval of tbo-filgrastim by the US FDA, Novation, a health care supply contracting company, has released a press release praising this important approval.

Novation states that, the important milestone represents the continued development of biosimilar pharmaceuticals in the United States. Although approved through a full Biologics License Application and not a formal “biosimilar”, this product is expected to fill the same role in clinical practice as subsequent biosimilars that are ultimately approved via the abbreviated pathway, signed into law in 2010. Sicor Biotech, a subsidiary of TEVA Pharmaceuticals is expected to begin marketing tbo-filgrastim in November 2013.

Biosimilars, which are ‘highly similar’ versions of reference biologics, are currently approved for use in the European Union and other regions. Research suggests that use of biosimilars could result in price decreases of 20 to 30 percent.

“Despite the slower pace of development in the U.S., biosimilars represent a much needed opportunity for lower-cost alternatives to commonly used biologics as hospitals struggle to contain drug related expenditures,” said Steven Lucio, PharmD, BCPS, director of clinical solutions, pharmacy, Novation. “Both this product and subsequently approved biosimilars will require a great deal of physician, pharmacist and clinical staff education to ensure appropriate use and meaningful uptake in the US market. Novation is committed to serving as a resource to help healthcare providers prepare for biosimilars and maximize their impact.”

The FDA approved Sicor’s tbo-filgrastim as a treatment for patients receiving cancer chemotherapy who experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.

Novation, the supply contracting company for the members and affiliates of VHA Inc, UHC and Provista, has actively monitored the development process for biosimilars, and how biosimilars have progressed in Europe to identify keys issues for hospitals considering biosimilar therapies.

Previously, Novation released a series of white papers, “Biosimilars – FDA Guidance Update,” and “Preparing for Biosimilars,” in 2011 and May 2012 to help hospitals and health care providers better understand the key components of the FDA’s draft guidance and the potential impact of biosimilar usage as they gain broader adoption in the United States.

 

Source: Novation press release

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