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Canadian company Apotex Inc. may be a step closer to bringing biosimilars of Amgen Inc.'s bone marrow stimulants Neulasta and Neupogen to market.
Apotex’s abbreviated biologics license applications to make the biosimilars of the Amgen biologics don’t infringe an Amgen patent on the products, the U.S. Court of Appeals for the Federal Circuit said in a nonprecedential ruling Nov. 13 ( Amgen, Inc. v. Apotex, Inc. , 2017 BL 405462, Fed. Cir., No. 2017-1010, nonprecedential, 11/13/17 ).
This battle between Apotex and Amgen over Neulasta and Neupogen is just the latest of Amgen’s attempts to protect its Neulasta franchise from competition. One biosimilar of Neupogen, Sandoz Inc.'s Zarxio, hit the market two years ago. Prior to the introduction of Sandoz’s biosimilar, in 2015, Neulasta produced $4.2 billion in global sales, $3.89 billion of that from the U.S.
Since Sandoz launched Zarxio, the first biosimilar approved in the U.S., Neupogen’s market position has declined, with 2016 sales falling by 27 percent from the previous year.
Apotex has filed applications to market biosimilars of Neulasta (pegfilgrastim) and (filgrastim) Neupogen. Both products are derived from a natural protein known as granulocyte-colony stimulating factor (or “G-CSF"). Neulasta has a polyethylene glycol unit added to it, enlarging the molecule to enable it to remain in the patient’s system longer than Neupogen.
Neulasta and Neupogen combat the lack of white blood cells, which is a common side effect of chemotherapy.
A biosimilar is a complex, large-molecule biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product or a branded biologic. Biosimilars are generally less expensive than biologics.
The Federal Circuit affirmed a 2016 lower court ruling finding that the process Apotex uses to make its biosimilars didn’t infringe Amgen’s U.S. Patent No. 8,952,138. The patent claims a process for refolding filgrastim and pegfilgrastim.
The appeals court said Amgen failed to prove Apotex’s refolding process for making the biosimilars met the patent’s protein concentration claim limitation, required to find infringement.
Jordan Berman, global director of corporate communications at Apotex Inc., told Bloomberg Law in a Nov. 14 email the company is pleased with the Federal Circuit’s decision but wouldn’t comment on how the decision could affect when Apotex could enter the market with its biosimilars. Apotex’s abbreviated biologics license applications are still under regulatory review at the Food and Drug Administration.
No one from Amgen, based in Thousand Oaks, Calif., was able to respond to a Bloomberg Law request for comment.
Judge Richard G. Taranto wrote the opinion. Judges Alan D. Lourie and Kathleen M. O’Malley also heard argument in the case.
Paul, Weiss, Rifkind, Wharton & Garrison LLP, represented Amgen. Cozen O’Connor represented Apotex.
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