Policy

CMS Payment Policy Plays Role in Biosimilar Uptake

January 30th 2020

By Tony Hagen

How does CMS payment policy for Medicare, Medicaid, and 340B hospitals affect biosimilar uptake? A speaker at the recent at the 2020 Specialty Therapies and Biosimilars Congress explained.

Sputtering Cost Reforms May Gain Momentum in 2020, but Patients Will Still Carry Higher Burden

January 23rd 2020

By Tony Hagen

Article

In a wide-ranging state-of-the-industry talk, the clinical operations manager for Blue Cross Blue Shield of Michigan discussed pending legislation, electronic prior authorization (ePA), and biosimilar uptake, among other prominent issues Wednesday at the 2020 Specialty Therapies and Biosimilars Congress in Miami, Florida.

Achieving Cost Savings With Biosimilars Will Require New Strategies, Authors Say

January 20th 2020

By Deana Ferreri, PhD

Article

Increasing trust in generics and biosimilars, and assuring their timely entry into the market, will yield greater benefit from these lower-cost options, according to a recent review.

Faster Drug Approvals, Weaker Data? Study Raises Concerns About FDA Process

January 14th 2020

By Deana Ferreri, PhD

Article

An accompanying editorial describes the current regulatory process as “a thicket of special programs, flexible review criteria, and generous incentives,” and suggests starting points for reforms, including improving access to biosimilars.

Lobbying Group Appeals Decision Allowing California Pay-for-Delay Law to Take Effect

January 9th 2020

By The Center for Biosimilars Staff

Article

The law made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company.

Time for Plans to Shoulder More Risk in Medicare Part D?

December 24th 2019

By Kelly Davio

Article

Among the features of the Part D structure is a federal reinsurance program in which, when a beneficiary reaches the catastrophic threshold in a given year, the government subsidizes 80% of remaining spending for the year. Part D plans pay 15%, and patients pay 5% in this scenario.

Federal Appeals Court Strikes Down ACA Individual Mandate, Sends Law Back to Lower Court

December 19th 2019

By Allison Inserro

Article

A federal appeals court Wednesday struck down the individual mandate—the heart of the Affordable Care Act (ACA) that requires everyone to have health coverage—and sent the case back to the federal district court in Texas to determine whether other parts of the law are constitutional and can exist without the mandate.

Do Biosimilars Have a Role in US Plan to Allow Imports?

December 18th 2019

By Allison Inserro

Article

Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the US versions. Under this pathway, drug makers would use a new National Drug Code (NDC) and sell the products in the United States at a cheaper price—but different NDCs will not be available for use by biosimilar manufacturers.

FDA Analysis Find More Evidence Linking Generic Competition to Lower Prices

December 16th 2019

By Allison Inserro

Article

Looking at products that entered the marketplace between 2015 and 2017, an FDA report finds that greater competition among generic drug makers is associated with lower prices.

Hahn Confirmed by Senate to Lead FDA, but Where Does He Stand on Biosimilars?

December 13th 2019

By Kelly Davio

Article

On Thursday, the Senate voted to confirm Stephen Hahn, MD, FASTRO, chief medical executive at the University of Texas MD Anderson Cancer Center, as the 24th commissioner of the FDA.