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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
As a result of the decision, Sandoz will be able to immediately launch Zarxio, the first biosimilar in the United States.
US District Judge Richard Seeborg ruled on Mar. 19, 2105 that neither Sandoz’s failure to supply its manufacturing information and biologics license application (BLA) for its filgrastim biosimilar to Amgen within 20 days of FDA’s acceptance of said BLA nor Sandoz’s plans to proceed to market “constitutes wrongful or unlawful behavior.” The choice to withhold BLA information is permissible in some cases, according to court proceedings: “The BPCIA renders permissible a subsection (k) applicant’s decision not to provide its BLA and/or manufacturing information to the reference product sponsor, subject only to the consequences set forth in 42 U.S.C. § 262(l)(9)(C). Such a decision alone does not offer a basis for the sponsor to obtain injunctive relief, restitution, or damages against the applicant; indeed, 42 U.S.C. § 262(l)(9) sets out the exclusive consequences for an applicant who elects not to provide its BLA and/or manufacturing information, or participate in any aspect of subsection (l)’s disclosure and negotiation process.”
Seeborg said there was “no basis on which Amgen is entitled to injunctive relief or other remedies for disadvantages it may suffer due to market competition from Sandoz” and dismissed Amgen’s conversion claim outright. As a result, Sandoz is free to begin marketing Zarxio (filgrastim-sndz) in the United States immediately.
The judge also ruled that giving an innovator drug manufacturer 180 days notice of a biosimilar maker’s intention to proceed to market would unfairly add “an unconditional extra six months of market exclusivity onto the 12 years reference product sponsors already enjoy.”
Amgen told various news outlets that the company plans to appeal the court’s decision; however, Sandoz may launch the product prior to an appeals court decision. Novartis told Reuters, “Given the importance of this case for future biosimilars, we agreed with Amgen before this hearing to jointly request expedited review of any appeal to the Federal Circuit.”