Biosimilars have to be, well, similar, but having to keep that relationship too tight over the long haul could keep companies from manufacturing innovation, Paul Eisenberg worries.
Eisenberg, a senior VP at Amgen ($AMGN), told the FDA that requiring developers of biogenerics and innovator drugs to maintain "biosimilarity over time would inhibit manufacturing and quality improvements and unduly burden industry without benefiting patients." His concerns are reported in in-PharmaTechnologist by Nick Taylor, who has been reviewing the documents.
Eisenberg's solution? The agency should recommend applicants establish an "internal reference standard" from analytical, nonclinical and clinical comparisons. After that, treat the biosimilar and its reference as independent drugs, "each standing on their own merits for future manufacturing changes and quality evaluations." Otherwise, he argues, the FDA will "unduly constrain manufacturing improvements across the industry."
What experts in biosimilar manufacturing have to say is of real concern to the FDA. First, biologics are much more sensitive to changes in manufacturing than simple small-molecule drugs. Secondly, the "abbreviated pathway" intended to get these less-expensive versions of biologics to market quicker is highly reliant on advances in manufacturing. The agency expects to be able to approve manufacturing changes based on "quality criteria and analytical testing."
That is why the FDA needs to be very clear, the Amgen exec believes. "The sensitivity of biologics to the manufacturing process is an issue FDA will have to address prior to designating one biologic product to be interchangeable with another," Eisenberg wrote.
- here's the in-Pharma Technologist story