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Appeals Court Blocks Sale of Neupogen Biosimilar
The U.S. Court of Appeals for the Federal Circuit has blocked the sale of Novartis’ recently approved biosimilar form of Neupogen (filgrastim), Amgen’s blockbuster drug used to treat neutropenia in cancer patients.
A lower court judge had rejected Amgen’s request for an injunction. The appeals court ruled on May 5, however, that the launch of the biosimilar, Zarxio, should be stopped “effective immediately” as long as there is an ongoing legal dispute against it. In a statement, Amgen said it is pleased with the ruling.
Filgrastim is a biologic, which means that generic copies of the drug’s organic substance cannot be made. Sandoz challenged the drug’s dominance in the U.S. by filing an application for its biosimilar version, which the FDA accepted in July 2014.
Because biosimilars are made in living cells, they are not considered exact duplicates of original brands, but use the same active ingredients to produce an effect that is similar to that of the original drug. It was only in 2010 that the review and potential approval of biosimilars in the U.S. received regulatory authorization under the Patient Protection and Affordable Care Act.
Biosimilar products can be approved by the FDA only if they have the same mechanisms of action, routes of administration, and dosage forms and strengths as the reference products, and only for the indications and conditions of use that have been approved for the reference products. The facilities where biosimilars are manufactured must also meet the FDA’s standards.
Neupogen biosimilars are already widespread in markets outside the U.S. Novartis has been selling a Neupogen knock-off under the name Zarzio in as many as 40 countries worldwide since 2009.
Insurers are hoping that biosimilars will be sold for discounts of 40% to 50% from the cost of the original brand-name products in the U.S., but Novartis has not yet disclosed the intended U.S. price for Zarxio.
In January 2015, Zarxio received a positive appraisal from the FDA’s Oncologic Drugs Advisory Committee (ODAC), which recommended approval. Amgen immediately sued Sandoz on the grounds of unfair competition and patent infringement, claiming that the company failed to meet disclosure prerequisites of Zarxio’s development under the Biologics Price Competition and Innovation Act.
While the court was still reviewing Amgen’s case, the FDA announced the first-ever approval of a biosimilar in the U.S. — Zarxio. Sandoz postponed the drug’s launch, however, until the court had ruled on Amgen’s injunction. Ten days later, a San Francisco-based federal judge gave a decision in Sandoz’s favor, only to be re-appealed by Amgen, this time against both the denial of its earlier petition as well as the court’s ruling in Sandoz’s favor. Despite the absence of any legal obligations to postpone the launch of Zarxio, Sandoz agreed to wait until May 11 or when a decision is made on Amgen’s second petition, whichever happens first.
The Federal Circuit will hold court on June 3 to decide whether the trial judge was justified in making Sandoz halt the launch of Zarxio even after FDA approval.
Zarxio was approved for the same indications as Neupogen, namely:
- Patients with cancer receiving myelosuppressive chemotherapy
- Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy
- Patients with cancer undergoing bone marrow transplantation
- Patients undergoing autologous peripheral blood progenitor-cell collection and therapy
- Patients with severe chronic neutropenia
Sources: Reuters; May 7, 2015; Bidness Etc; May 6, 2015; and FDA; March 6, 2015.