Perspective: The Promise of Biogenerics: Hope and Hype

| 01 January 2008

The year 2007 can be seen as the year when generic biologics came to the forefront of discussions in regulatory, scientific and business circles. Three bills were introduced in the US Congress to create an abbreviated approval pathway for biologics, like the one for conventional drugs.1 In March, the House Committee on Oversight and Government Reform held a hearing to discuss the need such a pathway and explore ways to create generic biotech drugs.2 Numerous reports-from professional, consumer and academic groups-were published in favor of and in opposition to the quick approval of regulations allowing generic biologics. One of the major reasons for this hoopla was that several important FDA regulations (including PDUFA and MDUFMA) were coming up for reauthorization in 2007 and the major stakeholders promoting biogenerics saw an opportunity to insert provisions for them. However, after prolonged and sometimes contentious discussions, biogenerics were omitted from the FDA Amendments Act of 2007, which was signed into law on 27 September. One wonders if biogenerics were excluded as the result of political pressure from influential groups or an extremely cautious approach on the part of the legislators.


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