Notice can be given before FDA approves biosimilar

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In a landmark decision by the US Supreme Court, biosimilars makers will be able to give notice to the originator manufacturer before the US Food and Drug Administration (FDA) has given final approval of the biosimilar.


The US Supreme Court heard oral arguments in Amgen vs Sandoz on 26 April 2017. The case came to the Supreme Court after the Court of Appeals for the Federal Circuit made the controversial ruling that the so-called ‘patent dance’ was optional, but also that the 180-day notice could only be given after the 12-year exclusivity period ended [1].

The Biologics Price Competition and Innovation Act (BPCI Act) of 2009, states that biosimilar applicants should provide a copy of their application to the originator manufacturer. However, it also states that should they fail to do so then the originator manufacturer ‘may bring an action’ to enforce its patents on the reference product.

Biosimilars makers took this to mean that providing a copy of the application was therefore optional.

Regarding timing of notification, the BPCI Act states that information on a biosimilar application should be provided ‘not later than 180 days before the date of the first commercial marketing of the biological product’.

Brand-name manufacturers interpreted this as meaning only once the biosimilar had been approved by FDA – effectively extending the originator’s exclusivity period by 180 days to 12 years and 6 months. Biosimilars makers, on the other hand, argued that the notice of commercial marketing could be given before FDA had approved the biosimilar.

The Supreme Court came down on the side of the biosimilars makers, saying that:

the ‘requirement that an applicant provide the sponsor with its application and manufacturing information is not enforceable by an injunction under federal law’.

and that:

‘the applicant may provide notice either before or after receiving FDA approval’.

Although the Supreme Court’s decision will have no effect on the original case as Sandoz launched Zarxio in September 2015 after waiting 180 days, it will most likely set a precedent on how the information exchange processes under the BPCI Act should be interpreted. This decision could also mean that biosimilars makers will be able to get their products to market faster in the US.

Carol Lynch, Global Head of Biopharmaceuticals, Sandoz, said that ‘the Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments’. She added that ‘we also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward’.

In fact, the decision could already have an impact in another case involving Amgen. The company has filed a motion for preliminary injunction seeking to enjoin Hospira from launching its proposed biosimilar of Epogen/Procrit (epoetin alfa) until Hospira has provided notice to Amgen ‘not later than 180 days before the date of the first commercial marketing of the biological product’. The US Supreme Court heard oral arguments in May 2017 and is expected to issue a decision during July 2017.

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1. GaBI Online - Generics and Biosimilars Initiative. How will the timing of BPCI Act 180-day notice affect biosimilars? []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from:

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Source: Sandoz, Supreme Court

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