Biosimilars one step closer to US market after FDA gives nod to Sandoz

The recommendation took place during a meeting of the Oncologic Drugs Advisory Committee (ODAC) yesterday at the US FDA's headquarters in White Oak, Maryland

Copycat versions of biopharmaceuticals in the US are a step closer to reality after an FDA review committee recommended a biosimilar of Amgen’s Neupogen.

At the Meeting of the Oncologic Drugs Advisory Committee (ODAC) yesterday, the US Food and Drug Administration (FDA) recommended the approval of Sandoz’s drug EP2006, a recombinant human granulocyte colony-stimulating factor. The product is a copycat version of Neupogen (filgrastim) made and marketed by Amgen submitted through the untested 351(k) biosimilar pathway and the recommendation is a milestone in bringing biosimilars to the US.

“We are pleased with the ODAC’s recommendation to approve our biosimilar filgrastim and we look forward to continuing to work with FDA as it completes its review of our filing,” Mark McCamish, Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz, said in a statement.

“We are proud to lead the way in biosimilars globally and believe this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the US.”

The Committee also recommended approval of the biosimilar for use in all indications included in the Amgen’s Neupogen, after the FDA found the analytical properties and efficacy of EP2006 were “highly similar, notwithstanding minor differences in clinically inactive components,” to the reference product.

According to one observer on Twitter, the FDA panel discussion was "amazingly brief" at only 17 minutes long, with the committee finding Sandoz's biosimilar to be comparable to the reference product:


According to the website drugs.com, 2013 sales of Neupogen in the US stood at $938m (€791m).

Sandoz, a subsidiary of Swiss Giant Novartis, markets EP2006 in more than 40 countries outside the US under the brand name Zarzio and according to the company last year saw the drug become “the first biosimilar to overtake its reference product and is now the most prescribed daily G-CSF in terms of volume in Europe and the number one daily G-CSF biosimilar globally.”

If approved, the drug will be marketed in the US under the brand name Zarxio.

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