How will the timing of BPCI Act 180-day notice affect biosimilars?

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How will the timing of BPCI Act 180-day notice affect biosimilars?

INICIO/Políticas y legislación | Posted 05/05/2017 0 Post your comment

On 26 April 2017, the US Supreme Court heard oral arguments in Amgen vs Sandoz. The case has come 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.

The ‘patent dance’ was designed to balance the needs of biosimilar and originator companies in a dispute. The patent dance begins with the disclosure of the biosimilar application, as well as the process of manufacture by the biosimilar applicant. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) specifies that the biosimilar applicant:

‘shall provide to the reference product sponsor a copy of the application … and such other information that describes the process or processes used to manufacture the biological product’.

The BPCI Act adds that the biosimilar applicant:

‘may include any additional information in support of the application, including publicly available information with respect to the reference product or another biological product’.

Biosimilar applicants have taken the position that the patent dance is optional, i.e. that they do not have to disclose the information specified above. They have come to this conclusion due to the fact that the wording is ambiguous (shall and not must) and the following provision also appears in the law:

‘If a [biosimilar] applicant fails to provide the application and information required … the reference product sponsor … may bring an action’ to enforce its patents on the reference product.

In fact, Sandoz (the generics division of Novartis) took this to be the case by not providing Amgen with a copy of its marketing application for its filgrastim biosimilar (Zarxio) and by providing notice before its product was licensed. Amgen subsequently sued Sandoz, saying that the company had not followed the rules of the BCPI Act [1].

With respect to the timing, the BPCI Act states that:

The information should be provided ‘not later than 180 days before the date of the first commercial marketing of the biological product’.

Brand-name manufacturers have interpreted this as meaning only once the biosimilar has been approved by the US Food and Drug Administration (FDA). This, however, effectively extends the brand-name biological’s exclusivity period by 180 days, to 12 years 6 months.

In the Amgen vs Sandoz case the companies have raised the following questions:

Can the notice of commercial marketing be given before the FDA has approved the biosimilar?
- The Federal Circuit has ruled ‘no’, Sandoz is saying ‘yes’
Do biosimilar applicants have to share their biosimilar application and other information in accordance with BPCI Act?
- The Federal Circuit has ruled ‘no’, Amgen is saying ‘yes’

Since FDA does not have the authority to oversee the ‘patent dance’ it will be up to the Supreme Court to decide on both of these questions. A definitive ruling is expected by July 2017.

Although the high court’s decision will have no effect on the original case as Sandoz launched Zarxio in September 2015 after waiting 180 days, it could set a precedent on how the information exchange processes under the BPCI Act should be interpreted. This in turn could have major implications for how soon biosimilars can reach the market in the US.

Related article
Amgen at the centre of biosimilars disputes

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Amgen sues Sandoz over filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 5]. Available from: www.gabionline.net/Biosimilars/News/Amgen-sues-Sandoz-over-filgrastim-biosimilar

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Source: BPCIA, Health Affairs, Patent Docs, PharmaPatentBlog, SCOTUS