As biosimilar drugs make their way to American soil, clinicians, regulators, pharmaceutical executives and patients alike are asking: How long will it take for the first biosimilars to reach the U.S. market? How much lower will their prices be than the original molecules they mimic? How quickly will they be accepted by clinicians and patients?
Biosimilar medications—also known as follow-on biologics—are virtually identical or highly similar versions of large and intricate biologic molecules like monoclonal antibodies. Brand-name biologics are already essential for the treatment of breast, colorectal, esophageal, gastric, head and neck, kidney and non-small cell lung cancers; and Hodgkin’s and non-Hodgkin’s lymphoma. They also are vital in the treatment of cancer- and chemotherapy-induced anemia and neutropenia. The hope is that biosimilars will significantly improve the affordability of, and access to, cancer medications.

The clock is already ticking toward the entry of biosimilars into the American market. This is because the 12-year patent-protection period will soon end for some brand-name products (Table 1, page 48). For the epoetin-alfa products Epogen (Amgen) and Procrit (Janssen Products), as well as Aranesp (darbepoetin alfa, Amgen) and Neupogen (filgrastim, Amgen), protection will run out in 2013. Some monoclonal antibody products, such as Rituxan (rituximab, Genentech/Biogen Idec), will likely lose their exclusivity protection as soon as the fourth quarter of 2015 and early 2016.

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