WHILE Australia has taken on the relatively simplistic a-flagging policy for biosimilars using the in-situ pharmacy substitution approach used for small molecule generics (PD 04 Apr), the US Food and Drug Administration (FDA) is adopting a more complex approach, releasing its draft guidance on biosimilar interchageability for consultation, noting that there is "no single data package that will work for all proposed interchangeable products."
The draft calls on companies to use so-called "switching studies" to determine whether alternating between a biosimilar and its reference product two or more times impacts the safety or efficacy of the treatment.
There appears to be some resistance in some of the feedback the FDA has received so far, according to the Regulatory Affairs Professionals Society.
For example the Ohio Public Employees Retirement System (OPERS) described the study requirements as "burdensome in terms of the length of time required for review and substantial patient study size", potentially delaying access and increasing costs which will ultimately be passed on to the consumer.
Non-US comparator products are also inappropriate according to the guidelines and there is strong support from the Coalition of State Rheumatology Organizations for using "actual patients" in switching studies as opposed to healthy volunteers.
CLICK HERE to access the FDA guidance and the RAPS summary.
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