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Novartis takes biosimilar delay complaint to Supreme Court

Seeks to overturn US law that requires 180-day launch delay after regulatory approval

NovartisA landmark lawsuit that could allow biosimilars to be launched in the US market more quickly is scheduled to be heard in the Supreme Court in April.

The suit has been brought by Novartis and will seek to overturn a US law that requires companies who secure approval for biosimilar drugs wait 180 days before they can commercialise the products. It is being supported by other biosimilar developers including Pfizer's Hospira subsidiary, Celltrion and Mylan.

Novartis is appealing an earlier ruling which ordered the company to delay launch of Zarxio, its version of Amgen's white blood cell stimulator Neupogen (filgrastim) and the first biosimilar to be approved in the US. Novartis won approval for Zarxio in March 2015 but was unable to launch until September of that year.

The Swiss pharma company has argued that the six-month delay constituted an unwarranted additional period of marketing exclusivity for branded biologic drugs that is unfair for biosimilar developers as well as healthcare payers and patients who have to wait longer for cheaper treatment options.

The legal wrangling centres on the interpretation of the Biologics Price Competition and Innovation Act (BPCIA), which created the regulatory approval pathway for biosimilars in the US.

Novartis' previous ruling did away with a requirement for biosimilar companies to inform branded product companies of their intentions to seek FDA approval 180 days in advance, which resulted in the so-called 'patent dance', with biosimilars tied up in the courts on patent infringement proceedings. The 180-day post-approval rule was however introduced at the same time.

"If not reversed, [the rule] will delay access by patients to all biosimilars for six months longer than Congress intended," said Novartis in a petition asking the Supreme Court to hear the case.

That sentiment was echoed by Celltrion and Hospira, which said in a joint statement that "given the importance of the issue to consumers, taxpayers and competition in a vital new pharmaceutical industry, review is needed now".

The Supreme Court will also hear an appeal by Amgen, which argues that brand name companies should be able to access a copy of the biosimilar marketing application dossier after approval. This was previously required but was overturned in the earlier Zarxio ruling.

Assuming proceedings start in April, a judgment on the 180-day launch delay is expected in July.

Article by
Phil Taylor

16th January 2017

From: Regulatory



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