3:29 PM
Apr 12, 2019
 |  BC Extra  |  Politics & Policy

Generics would get a new boost from bipartisan bills

A new bipartisan package of bills introduced in the Senate mark the latest effort to boost generic and biosimilar competition.

Sen. Bill Cassidy (R-La.) and co-sponsors announced the bills Friday, which aim to increase market entry for generics by targeting legal maneuvers and stall tactics used by branded drugmakers to keep generic competitors at bay, and block insulin makers from claiming new market protections against biosimilars.

Cassidy and Sen. Dick Durbin (D-Ill.) are co-sponsoring the Reforming Ever-greening and Manipulation that Extends Drug Years (REMEDY) Act. If enacted, the legislation would reduce the risk of litigation for generic drugmakers once a substance patent and exclusivities have expired.

The Ensuring Timely Access to Generics Act, co-sponsored by Cassidy and three other senators, would empower FDA to reject Citizen's Petitions used by branded companies solely to delay competition.

The third bill, Protecting Access to Biosimilars Act, is aimed at promoting biosimilars for insulin, which will be regulated by FDA as a biologic starting in 2020. The bill, co-sponsored by Cassidy and Sen. Tina Smith (D-Minn.), would prevent companies from extending market protections for insulin under the new regulatory paradigm, announced by FDA last year in an effort to increase insulin competition (see “FDA Biosimilars Policies Will Bring Interchangeable Insulin to Market”).

Earlier this year, Democrats in the Senate introduced two versions of legislation that threaten to offer competitive licenses to generic drugmakers if branded drug companies do not negotiate with Medicare in good faith (see “Democrats Reintroduce Medicare Price Negotiation Bill”).

The Senate is also considering the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which ensures access to drug samples required for developing generic or biosimilar drugs. CREATES is also under consideration in the House, where a version moved out of committee last week (see “Bipartisan Approval for CREATES in House Committee”).

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