Biosimilar Manufacturers Must Wait Six Months After Approval to Market Product

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A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

Biosimilar manufacturers will have to wait at least 180 days, or six months, to launch their products in the market following regulatory approval, a Federal circuit appeals court ruled on July 21, 2015. The decision on the commercial launch of a biosimilar comes as a result of court proceedings in the ongoing battle between Amgen and Sandoz regarding the approval and launch of Sandoz's Zarxio, its biosimiar version of filgrastim.

While the argument between the two pharmaceutical companies is based primarily on the proper following of the rules laid out in the Biologics Price Competition and Innovation Act (BPCIA), the suit also deals with patent litigation. Amgen has also filed a declaratory judgment action against Sandoz claiming patent infringement of a method involving the use of granulocyte colony stimulating factor (G-CSF) to treat a disease requiring peripheral stem cell transplantation.

Although the judge upheld the District Court's decision that the "patent dance" provision of the BPCIA is optional, and biosimilar companies would not be required to disclose the details of their manufacturing dossiers, the marketing portion regarding innovator company notification of commercial marketing following biosimilar product approval still stands.


As a result of the ruling, Sandoz cannot launch Zarxio earlier than Sept. 2, 2015. The new ruling contradicts the thoughts of US District Judge Richard Seeborg, who previously ruled on March 20, 2015 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.”