RT-NEW YORK, NY, Jun 07, 2011 (MARKETWIRE via COMTEX) -- The biotechnology sector is bracing for change this year as a flurry of "biosimilar" or "biogeneric" drugs hit the market. "Biotech drugs are among the world's most expensive," said Sidney Wolfe, director of the health research group at Public Citizen. "They have been good, but they have been expensive, so it is extraordinarily important to get biogenerics as quickly as possible." Under the US healthcare reform law passed last year, brand-name biotech drugs were granted a 12-year period of market exclusivity, after which generic versions can be sold. They range from relatively simple molecules like insulin to complex antibodies used to treat cancer. Biosimilars had been unavailable in the US because they were not part of the 1984 Hatch-Waxman Act that allowed for cheaper generic versions of chemically derived drugs.
Chris Viebacher, CEO at French drugmaker Sanofi explains that some biotech drugs are more vulnerable to competition than others. "It is going to be interesting to see, particularly over the next five years, who actually decides to do what in terms of biosimilars," he added.
According to Global Industry Analysts, the global market for biosimilars is forecast to reach US$4.8 billion by the year 2015 driven by patent expiries of key biological drugs, cost containment measures from governments, aging population, and supporting legislations. Europe represents the largest affiliate regional market for biosimilars worldwide, as stated by the report. Nearly eight years ago the European Union passed legislation creating a mechanism for the approval of generic biotech drugs.
Biotech firm Human Genome Sciences recently received European approval of human use for their Lupus Drug, Benlysta-belimumab.
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