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6 March 2018AmericasHenk Heus and Ellen Sherin

Getting into the biosimilars action

In March 2016, the Federal Trade Commission (FTC) filed a suit against Endo Pharmaceuticals (among others) for blocking generic competition of its Opana ER (oxymorphone hydrochloride) and Lidoderm (lidocaine) products. It alleged that in addition to paying to delay competitive products, Endo used a no-AG (authorised generic) commitment that gave Watson Laboratories more than seven months of its own monopoly on the market during which Endo would not compete.

To put this into perspective, the FTC’s complaint states that in 2011, Endo generated more than $825 million, or 30% of its total revenue, from Lidoderm (a pain patch). The complaint alleged that, to stave off a generic threat from Watson, Endo provided payments and incentives worth $250 million. Although this suit was settled in January 2017, the FTC refiled charges against Watson for illegally blocking a lower-cost generic version of Lidoderm when it entered into a pay-for-delay agreement with Endo.

Clearly, the opportunities for generic drug products are huge, but there are regulations that must be adhered to when assessing the best ways to maximise a company’s return on drug development investments or planning an entry into a market with a new biosimilar product.

Take, for example, Novartis-owned Sandoz, which released Zarxio in September of 2015. Zarxio is a copycat version of Amgen’s billion-dollar Neupogen drug and the first US Food and Drug Administration (FDA)-approved biosimilar drug launched in the US—the world’s largest pharmaceutical market. It is currently sold at 15% below the price of the original drug.

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