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14 March 2017Americas

Sandoz ‘undermines’ innovation and consumer balance, says Amgen

Amgen has said in a brief filed at the US Supreme Court that Sandoz “attempts to undermine” the balance between innovation and consumer interests.

In its opening brief in Sandoz v Amgen, filed on Friday, March 10, Amgen asked the court to answer whether a biosimilar applicant, after receiving approval for its drug, is required to provide the sponsor with 180 days’ notice before it begins marketing a biosimilar product.

Expanding on its first question, Amgen is also requesting the Supreme Court to clarify whether a court can enforce that duty.

It also asked whether an applicant is required to provide the sponsor with a copy of its biologics licence application as well as other related manufacturing information, and whether that is enforceable by a court.

The case between the two parties arose after Amgen and Sandoz disagreed on the interpretation of the Biologics Price Competition and Innovation Act (BPCIA).

Amgen and Sandoz claim different interpretations of the statute, which states that an applicant “shall” provide its application and manufacturing information.

Here, Sandoz claims that the wording “shall” means that providing an application and manufacturing information is optional, as opposed to Amgen, which interprets the meaning as mandatory.

Amgen’s Neupogen (filgrastim) had been marketed since 1991, but in May 2014 Sandoz filed an application at the FDA for approval of a biosimilar under the brand name Zarxio.

Sandoz notified Amgen that it intended to bring Zarxio to market immediately after receipt of FDA approval. It further informed Amgen that it would not provide its biosimilar application to

Amgen and that Amgen was entitled to sue Sandoz.

Zarxio was approved by the FDA in March 2015.

In January the Supreme Court agreed to hear the dispute between the two parties after accepting Sandoz’s writ of certiorari.

President Donald Trump’s nominee for solicitor general, Noel Francisco, said in February this year that the US Court of Appeals for the Federal Circuit erred in holding that biosimilar applicants must give 180 days’ pre-marketing notice.

His statement was made in an  amicus brief filed at the Supreme Court.

It argued that the BPCIA text “directly addresses the requisite timing by specifying the ‘late[st]’ date ‘before’ commercial marketing on which notice must be given”.

The Federal Circuit had also held that the exchange of information, known as the ‘patent dance’, is optional.

The Biosimilars Council, a division of the Association for Accessible Medicines, recently  filed a brief in support of Sandoz.