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Biosimilars and the Supreme Court: Sandoz v Amgen

Written by: Guest Author on Friday, July 7, 2017 Posted in: Home Infusion, Specialty Pharmacy

By: Ron Lanton, President, True North Political Solutions

Biosimilars, which are “highly similar” to already approved biological products, are becoming more important in the market because they enable patients to access more treatment options, particularly more expensive options, at prices that are more affordable. Obviously, the makers of the brand-name biologics are not in favor of biosimilars of their top-selling products. Recently, however, the Supreme Court of the United States gave biosimilars a win against brand biologics in the case of Sandoz v. Amgen. What does this mean for the specialty pharmacy market?

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There are two issues that were answered by the Court in this case, which revolved around Amgen’s approved biologic, Neupogen.

  • Did Sandoz, makers of the biosimilar product in question, give proper notice to Amgen of its intent to market a biosimilar of Neupogen?
  • Is Amgen entitled to an injunction, stopping Sandoz’s application to the FDA until Sandoz gives Amgen its research and FDA application?

The court’s ruling in this case has now opened the door for biosimilars to enter the market faster, which gives specialty pharmacy patients more options for treatment.

The market for biosimilars was created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which was part of the Affordable Care Act, a.k.a. Obamacare. This act allowed for the creation of biosimilars and created a mechanism within the FDA for their approval. The Court, in Sandoz v. Amgen, looked to the BPCIA in establishing a decision in this case.

Sandoz and its biosimilar clearly won out on the first question. The court stated that the biosimilar manufacturer could simultaneously enter its application to the FDA and give notice of its intent to market to Amgen. This part is the most important part as it allows the biosimilar to reach the market faster. Amgen wanted the court to rule that the FDA application had to be approved before the notice of intent would be allowed. In ruling for the biosimilar, the Court denied Amgen more time to exclusively market Neupogen without biosimilar competition.

On the second question of the injunction, the biosimilar won again because the Court ruled that the question did not need an answer. Amgen had received the application and research information from Sandoz in discovery. Here, the Court intended to be cautious as the BPCIA did not bar the makers of brand-name biologics from obtaining relief in state court, which could have opened the door for more litigation in the states regarding patents for biologics.

These recent decisions have major consequences for the makers of brand biologics, who are trying to protect their patents. With the required notice of intent to market being 180 days, it’s possible that, if the FDA takes 180 days to approve a biosimilar application, the biosimilar can immediately start to market its treatment. This means more options. It also means that, as more biosimilars go to market, the higher the chances that the FDA will approve interchangeability of the various brands’ treatments.

Currently, no biosimilars are considered interchangeable. Also, theoretically, as there are more biosimilars introduced, it is hoped that biological pricing will go down even more. All of this means that there will be greater access to different treatments for specialty pharmacy providers to help their patients.

Gaining access to these complex biological treatments is an intensive process that requires detailed documentation and outcomes reporting. CareTend, the latest software solution designed especially for specialty pharmacies, can help you meet manufacturer and payer requirements.

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