Senate health bill pharma-friendly on biologics, price controls

Share this article:
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.
Share this article:

Email Newsletters

More in News

Five things for pharma marketers to know: Thursday, August 21

Five things for pharma marketers to know: Thursday, ...

An Ebola survivor is set to leave Emory University Hospital, but the cause of the cure is uncertain, the FDA has approved a new type 1 diabetes test, and the ...

Sanofi expands Gaucher disease portfolio

Sanofi expands Gaucher disease portfolio

The oral medication Cerdelga joins Cerezyme in its Gaucher disease arsenal. Sanofi expects the drug will be priced "on par" with Cerezyme, which goes for around $300,000 a year in ...

Amicus seeks to upset Fabry market

Amicus seeks to upset Fabry market

Phase-III tests indicate patients may be able to switch from injectable enzyme-replacement therapies, like Fabrazyme, to the firm's oral drug.