Amgen offers testimony at FDA biosimilars hearing

Hearing follows February release of draft guidances on biosimilars development

THOUSAND OAKS, Calif. — Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

Amgen said Friday that it would send SVP research and development Joseph Miletich to urge the FDA panel to establish approval standards that "advance patient safety and promote confidence in biosimilars marketed in the U.S."

"While much more is known today than 30 years ago, the FDA's guidance documents should candidly acknowledge that there are some things we still do not scientifically know today," Miletich said in a statement.

Miletich plans to make three recommendations to the agency as it finalizes its guidances: Adopt policies to facilitate attribution of adverse events and foster manufacturer accountability; conduct a communications campaign about biologics and biosimilars; and foster supply chain stability.

Sandoz, the generics division of Swiss drug maker Novartis that makes biosimilars for the European market, announced Wednesday that it would be testifying as well. The hearing relates to draft guidances concerning the development of biosimilars that the agency released February.


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