Biosimilars Update: FDA Staff Recommends Approval of First Biosimilar in U.S.; Agency Accepts Third Biosimilar Application For Review

FDA’s “Purple Book,” which lists all licensed biological products, currently has an empty column under the “biosimilar” heading, which would state imitation products deemed “highly similar” next to the listed reference. That may change soon. Tomorrow, the FDA will consider whether the Agency should approve Novartis AG's copy of Neupogen, Amgen Inc.'s successful injectable biologic used to prevent infection in patients on chemo therapy. FDA staff reviewers recommended approval for the copy on all five of its proposed indications yesterday. View the FDA Briefing Document in advance of the Oncologic Drugs Advisory Committee Meeting, scheduled for tomorrow, January 7, 2015.  The inherently complex nature of biologics like Neupogen makes them expensive to develop and impossible to copy in the manner traditionally associated with the approval of generic drugs. Most biologics are produced in living organisms, such as plant or animal cells, whereas small molecule drugs (most pharmaceuticals) are typically manufactured through chemical synthesis. Thus, even creating "similar" biologics is an inherently unpredictable process.  To aid firms in creating cheaper generic options for biologics--potentially saving the U.S. billions in brand-name alternatives--the Affordable Care Act included an abbreviated approval pathway for products that are demonstrated to be "highly similar" (as opposed to identical) to an FDA-approved biological product. In May, FDA cam...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs