The Senate health reform bill would maintain the ban on price controls in the Medicare prescription drug benefit and establish a 12-year data exclusivity period for biologics.
Like its House counterpart, the Senate’s Patient Protection and Affordable Care Act establishes a pathway for approval of so-called biosimilars, or generic biologics. And as with the House legislation, the Senate version grants manufacturers of innovator drugs 12 years of data exclusivity, meaning that makers of biosimilars cannot piggyback on the innovator’s clinical trials data until 12 years after the innovator’s approval.
That sets a higher bar for biosimilars than is faced by generics, because within that 12-year window, the makers of biosimilars must conduct their own costly clinical trials in order to launch a challenger.
The Senate bill also grants biologics marketed for the treatment of rare disorders 7 years market exclusivity, extending the same protection granted small molecule compounds under the Orphan Drug Act. Companies can file for ordinary biosimilars 4 years after approval of the innovator product.
Unlike the House bill, the Senate bill does not authorize direct government negotiation of drug prices for the Medicare prescription drug benefit – a provision that PhRMA and AstraZeneca’s David Brennan have called a deal-breaker. Language to that effect, contained in the House bill, would obviate the non-interference clause established in original Medicare Part D legislation.
