Amgen proposes key hurdles for biosimilar regs
Today marks the official beginning of the FDA's marathon run toward a new set of regulations to govern the development of biosimilars. Regulators will host their first public meeting on follow-on drug regs, and you can expect to hear plenty from big companies like Amgen ($AMGN) on the need for lengthy and expensive clinical trials.
As Reuters notes, the agency has no deadline for coming up with new biosimilar rules. Despite some early optimism, the experts see the field growing slowly, with the first significant set of approvals coming in 2014 or 2015.
Amgen, which has the most to lose at an early stage as copycat anemia drugs loom, is sending its SVP for R&D, Joe Miletich, to lay out its demands for three key criteria: "Use well-designed clinical trials to establish biosimilarity; ensure the product manufacturer and lot number is known for all administered biological; and set scientific and practical criteria for interchangeability."
"Minor changes in structure, formulation or impurities can have a significant impact on patients that cannot always be anticipated with analytical studies," said Miletich.
"It's a complex challenge. I can't put dates on our timelines for implementation," FDA Commissioner Margaret Hamburg mentioned last fall. "People will be frustrated," policy consultant Ian Spatz tells the wire service. "It's not going to be a clear pathway for everything."