President Obama's budget would pave the way for government to approve generic versions of biologic drugs, an administration official said yesterday, a move that could save taxpayers, insurers, and patients billions on the world's most expensive drugs but could hurt profits of some Massachusetts biotechs.
The Food and Drug Administration currently has no process for approving biogenerics, also called "follow-on biologics" and "biosimilars." Such drugs are made from living organisms, not chemicals, and are extremely difficult to duplicate precisely. Congress in the last few years has haggled over how to create regulations to approve generic versions of biologics.
The generic industry has proposed letting companies copy biologics after three to five years, similar to rules set for conventional drugs under the 1984 Hatch-Waxman Act. The administration's proposal suggests the time frame would be consistent with Hatch-Waxman, though administration officials could not confirm that last night.
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