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HOLZKIRCHEN, Germany — The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.
Sandoz, the generics arm of Swiss drug maker Novartis, and a major supplier of biosimilars, said its head of global biopharmaceutical development, Mark McCamish, will testify on what it called the need for a single, science-based regulatory standard that the FDA should apply across all biologics. The FDA released draft guidances in February.
"Sandoz is pleased that the FDA has taken another step toward increasing patient access to affordable, high-quality biologics," McCamish said. "We support the flexibility of the draft guidances and hope that [the] FDA will provide similar science-based, pragmatic approaches in its final guidelines."
In advocating for a single standard, McCamish will note that several originator biologics have undergone manufacturing changes since their commercialization, saying that it creates "highly similar" biologics that overlap with the originator products' attributes, saying that such a highly similar product should justify abbreviated clinical trial programs, as outlined in the draft guidances.
McCamish also plans to say that biosimilar clinical studies are only confirmatory because advances in biotechnology allow a biosimilar manufacturer to use various means to more efficiently pick up differences between a biosimilar and its reference product than any clinical trial, thus allowing full characterization between the two products. Third, he will address interchangeability between biosimilars and their reference products.
Sandoz currently makes biosimilars mostly for the European market, alongside Teva Pharmaceutical Industries and Hospira. While the healthcare-reform law included a regulatory approval pathway for biosimilars in the United States, so far the only biosimilar available here is Sandoz's Omnitrope (somatropin [rDNA origin]), a treatment for children with growth hormone deficiencies and a biosimilar of Pfizer's Genotropin.