Biosimilares se pueden "merendar" el mercado de insulinas y de ....

Since the launch of the first biosimilar human growth hormone in 2006, biosimilars have become increasingly important to pharmaceutical companies as they try to protect revenue streams from their major brands. Previously, branded biologics were protected from the type of generic erosion that eventually faces all small-molecule therapies by the absence of an abbreviated regulatory pathway for approval of biosimilars. As regulatory agencies have now established, or are in the process of establishing, pathways for approval of biosimilars, companies marketing major biologic brands need to characterize and account for impending competition.

This report forecasts the impending erosion faced by the following biologic drugs used in nephrology and endocrinology:

- Erythropoiesis-stimulating agents (ESAs)—for example, Amgen’s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa); Johnson & Johnson’s Procrit/Eprex (epoetin alfa).

- Insulins and insulin analogues—for example, Eli Lilly’s Humulin (insulin isophane) and Humalog (insulin lispro); Sanofi-Aventis’s Lantus (insulin glargine); NovoNordisk’s Levemir (insulin detemir) and NovoLog/NovoRapid/NovoMix (insulin aspart).

- Human growth hormones (hGHs)/Somatropin—for example, Pfizer’s Genotropin; Eli Lilly’s Humatrope; Novo Nordisk’s Norditropin; Roche’s Nutropin.

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