I can only shake my head on days like today when I read about the state of biogenerics policy in the United States. The Wall Street Journal reports (Firms Push for Biotech Generics) that biotech companies are lined up against health plans and PBMs over the interpretation of the waiting period for biogenerics embedded in the Patient Protection and Affordable Care Act (PPACA). The dispute is over the meaning of the 12 year ’exclusivity’ period specified in the Act. Biotech companies want generic companies to wait 12 years before starting development (that’s ’data exclusivity’), while PBMs that distribute drugs and health plans that reimburse for them want companies to wait 12 years before the drugs are sold (’market exclusivity’). The PBM/health plan position is somewhat better for consumers, because it would get the drugs on the market a year or more earlier, but this really shouldn’t be the debate we’re having.
To read the full, original article click on this link: Biotech companies, government need to forge a new concept of biogenerics
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