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:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

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

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...