In an announcement on Monday the Food and Drug Administration (FDA) said it will hold a meeting with industry stakeholders on December 16 to discuss the development of fee system for biosimilars – generic versions of biologics – that will help pay for its review activities.
In response the Pharmaceutical Research and Manufacturers of America (PhRMA) said it is pleased the FDA will “solicit stakeholder input…about the proposed user fees and performance goals for biosimilars. We endorse a clear, science-based, separately funded regulatory program for biosimilars that is supported by a mix of appropriations dollars and user fees.”
The draft fee proposals - available here - includes a special protocol assessment mechanism for clinical trials intended to establish biosimilarity and or interchangeability with innovator biologic drugs.
“This provision,“ PhRMA said “will help to ensure that clinical trials are designed to thoroughly assess the safety and efficacy of biosimilar medicines, in accordance with the FDA’s high regulatory and scientific standards.”
Big business looks at biosimilars
PhRMA’s comments come just a day after South Korean conglomerate Samsung announced a new collaboration with US biologics developer Biogen Idec.
The deal – the first since Samsung and Quintiles set up Samsung Biologics earlier this year – underlines the South Korean giant’s interest in the biogenerics market.
News of the FDA meeting also follows just weeks after Dong-A – also based in South Korea – and Japanese partner Meiji Seika said they have teamed up to build a biosimilar production facility.
These investments– as well as others by companies whose core activities are outside the pharma industry like Fujifilm and Mitsubishi – underline the potential for profit that the biosimilar market holds and are sure to be in the thoughts of drugmakers that attend the FDA’s meeting next week.