Policy

Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York, discusses recent regulatory actions to promote biosimilars.

Amid the coronavirus disease 2019 (COVID-19) pandemic, the FDA issued guidance stressing the importance that manufacturers notify it of discontinuations and manufacturing interruptions so that the agency can implement contingency measures.

Two doctors call for interchangeability requirements for biologics to be waived for insulin products under the new regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA) of 2009.

Life under the new biologics pathway will be easier for some drugs than others, notes Stacie L. Ropka, PhD, JD, a patent attorney with Axinn, Veltrop & Harkrider LLP, in Hartford, Connecticut.

“We're always under the tyranny of the 10-year budgetary window that the CBO [Congressional Budget Office] models under,” said Rep. Michael C. Burgess, MD, R-Texas, in a discussion of the limitations of the US system for bringing biosimilars to the market.

Legal and industry experts ponder whether expanded access to biosimilars is a way around patent thickets that slow the launch of approved biosimilars.

Two new bills aimed at increasing access to biosimilars and saving billions of dollars in out-of-pocket costs have been introduced in Congress. Both have been referred to committees for further review.

Sheila Frame, the vice president of marketing, market access, and patient services at Sandoz, discusses US biosimilar policies in development and the impact they will have on the market at the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California.

The Center for Biosimilars® recaps the top stories for the week of March 9, 2020.

As regulators work to increase competition and lower costs in the insulin market, CMS has released a new Medicare model intended to lower co-pays for insulin products to a maximum of $35.

Two regulatory experts said in an editorial that suffixes for biosimilars can support adverse event reporting and build provider and patient confidence in biosimilars.

There are several pending legislative proposals in both the House of Representatives and the Senate designed to encourage more commercialization of biosimilars, but the 2020 election may determine their timing.

Although biosimilar insulins are available in Europe, there are none in the United States currently, although that is slated to change.

The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.

Katie Verb, director of policy and research for the biopharmaceutical industry group PhRMA, discusses recent policy changes that have increased biosimilar uptake and additional measures that could lead to greater use of biosimilars and savings for CMS and patients.

The US biosimilars market is showing healthy vital signs, said Leah Christl, Amgen’s executive director for global regulatory and research and development policy, in a talk kicking off the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California, while also reassuring the audience that her former FDA colleagues are still champions of their work.

The Center for Biosimilars® recaps the top stories for the week of February 24, 2020.

The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLAs before a certain date.

The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.

In an effort to speed more generic drug approvals, the FDA said it is changing how it assigns priority review status to abbreviated new drug applications.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.