Lupin 2023

Sandoz biosimilar receives backing of FDA panel

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WASHINGTON — A Food and Drug Administration panel has recommended that the agency approve what could become the country’s first biosimilar.

The panel unanimously urged approval of Sandoz’s filgrastin (Neupogen), a cancer treatment.

“This encouraging step forward means that it is very likely now only a question of when, rather than if, filgrastin will be available for patients in the United States,” said Ralph Neas, president and chief executive officer of the Generic Pharmaceutical ­Association.

The drug, also known as EP2006, could receive final approval this year. The agency often accepts recommendations from its advisory panels, but it is not bound to do so. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, called the meeting earlier this month of its oncologic drugs advisory committee “a historic occasion.”

Although uncertainty exists over how biosimilars would be priced in the United States, they cost 20% to 30% less than the original biologics overseas, where markets for biosimilars already exist.

In 2013, Neupogen posted global sales of about $1.4 billion. Sandoz already markets its Neu­po­gen biosimilar under the Zarzio name in over 40 countries and claims to hold more than 50% of biosimilar approvals in Australia, Canada, Japan and European countries.

In the United States, a second biosimilar is already awaiting FDA review, a less expensive version of Remicade — Johnson & Johnson and Merck & Co.’s rheumatoid arthritis drug, which garnered 2013 international sales of about $8.4 billion. Biosimilars of the drug are already available in India and Japan.

Meanwhile, the FDA and drug manufacturers are still working out the rules that biosimilar manufacturers must follow in this country, including naming and the process of substitution.

“We look forward to the day when millions of Americans can choose safe, effective and more affordable biosimilar therapies,” Neas remarked.


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