Teva asks FDA to define Copaxone as biologics drug


The Israeli pharmaceutical company is still investing major efforts to prevent further generic competition for its multiple sclerosis treatment.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) is continuing to invest major efforts in protecting its most valuable ever asset - multiple sclerosis treatment Copaxone. Teva has asked the US Food and Drug Administration (FDA) to include Copaxone in the list of biologics drugs that it will issue next month.

Such a move will make it more difficult to make copycat generics of Copaxone, although this will be shutting the stable door after the horse has bolted with some generic rivals of the multiple sclerosis treatment already on the market. Nevertheless, it may hamper approval of future Copaxone generics.

Over the past two decades, Copaxone has been a cash cow for Teva, culminating in annual sales of $4.2 billion in 2013. Since then generic rivals have been available and sales have fallen 64% by last year to $1.5 billion 9including $1 billion in the US) and are expected to fall to $1.2 billion in 2020. Even so this is still a significant amount of revenue.

FDA's biologics list follows legislation enacted by the US Congress protecting biologics drugs. The FDA has published an initial list of 100 drugs to be included on the list as biologics drugs from March 2020, which would require budding generics to pass through the more complex biosimilars track before receiving approval.

Copaxone has not been included in this list but Teva has written to the FDA requesting that it should be. Teva points out that the FDA has previously stated that Copaxone is different from a protein because it has no defined or specific sequence and cites two drugs on the FDA's biologics list that are similar to Copaxone - Bausch + Lomb’s Vitrase and AbbVie’s Creon.

Published by Globes [online], Israel business news - - on February 26, 2020

© Copyright of Globes Publisher Itonut (1983) Ltd. 2020

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