Lawmakers propose pathway for approving biosimilars

A group of lawmakers on Capitol Hill has introduced legislation that establishes a clear pathway for the approval of biosimilars. The bill has already attracted the wide support of a diverse group of lobbyists, including the AARP, health plans and pharmacy benefit managers, who would like to see the price of complex biotech drugs go down. BIO has long been on record that it isn't necessarily opposed to biosimilars--cheaper follow-on versions of branded biotech drugs--but insists that the complexity of biologics requires the FDA to insist on a separate set of expensive studies before any follow-on therapy can be approved. In Europe the EMEA has had a regulatory pathway in place for almost three years.

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