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Questions over US biosimilars pathway in light of Teva’s BLA Posted 20/05/2011

Questions have arisen over whether the abbreviated pathway for approval of biosimilars in the US will ever be used. Many believe that biosimilars manufacturers will opt out of this pathway and use the normal route via a Biologic License Application (BLA). This is backed up by the fact that Teva’s biosimilar, Neutroval, was submitted to the FDA via the normal BLA route.

Healthcare reform in the US was brought in to force in March 2010. This reform also allows for a pathway for marketing approval of biosimilar medicines, by including The Biologics Price Competition and Innovation Act of 2009, which established an abbreviated Biologic License Application (aBLA) pathway for the approval of biosimilars.

Teva preempted the new biosimilar pathway by filing a standard BLA for Neutroval (granulocyte colony-stimulating factor), a biosimilar version of Amgen’s Neupogen (filgrastim). Some have suggested that filing a standard BLA instead of a biosimilar application with the FDA may be the favoured route for biosimilar manufactures because (1) the 12 year exclusivity period for innovators does not apply to new applications; and (2) the difference in the amount of data the FDA requires under the two routes might be very small.

The FDA acted on Teva’s Neutroval BLA by issuing a complete response letter on 30 September 2010 requesting further information, but no additional clinical trials. Given that Teva obtained European regulatory approval for the drug TevaGrastim in 2008 using the EMA’s abbreviated biosimilar pathway it is therefore speculated that the FDA may be amenable to ‘slimmed-down BLAs’ that rely on reference product data.

Marketing analysis group inThought —part of Wolters Kluwer Pharma Solutions—agree with this speculation, stating that ‘the aBLA pathway may never be used’. While attendees at the ‘Business of Biosimilars’ meeting in Boston, USA, in September 2010, expressed their concern that, because of unclear requirements for clinical data and the need for public disclosure of proprietary data, manufacturers of biosimilars are unlikely to take advantage of the aBLA process, opting instead for a standard BLA.

Whatever the means of registration, biosimilars can only be good news for governments and patients alike with reductions of 30% in costs with the introduction of a biosimilar to the market expected.

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Source: BioLawGics, Ingentaconnect

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