Policy

The Senate may not consider the FDA Reauthorization Act (FDARA) until early September, after the congressional recess. The delay comes after Senator John McCain (R-Arizona) returned to the capitol to vote in favor of advancing a debate over healthcare reform.

FDA Commissioner, Scott Gottlieb, MD, testified before the House Judiciary Committee this afternoon in a hearing titled “Antitrust Concerns and the FDA Approval Process.”

This week, the House of Representatives passed the Medicare Part B Improvement Act, a bipartisan bill that, among other provisions, seeks to amend title XVIII of the Social Security Act in order to address the delivery of at-home infusion therapy.

While all eyes have been on the Senate, the House has been quietly preparing to address another key issue affecting healthcare.

The American College of Rheumatology has issued a response to CMS’ 2018 Physician Fee Schedule proposed rule, which was issued earlier this month.

The Food and Drug Reauthorization Act of 2017, recently passed by the House, reauthorizes the Biosimilar User Fee Act (BsUFA). Learn about changes to the BsUFA in its new iteration, BsUFA II.

The American Society of Clinical Oncology (ASCO) has issued an official position statement addressing the affordability of cancer drugs. The position was guided, the organization says, by several key principles.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 17, 2017.

The cost of developing copy versions of complex drugs—biosimilars and follow-ons for biologics and copies of nonbiological complex drugs such as nanomedicines, including drug-carrying liposomes—can be decreased, according to a new white paper.

The 2018 Medicare Physician Fee Schedule Proposed Rule, issued by CMS on July 13, considers changing a contentious billing code policy affecting biosimilar products.

On Tuesday, the FDA held a public meeting titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.”

On Monday night, Senators Mike Lee (R-Utah) and Jerry Moran (R-Kansas) announced their opposition to the Republican healthcare reform bill, the Better Care Reconciliation Act (BCRA).

A new report shows that most US-based health plans now cover at least 1 of the 2 FDA-approved biosimilars currently available in the marketplace.

The Association of the British Pharmaceutical Industry (ABPI) announced his week that it has applied for judicial review of a new budget impact test implemented by the National Institute for Health and Care Excellence (NICE).

In its annual report, issued earlier this week, the Medicare program’s trustees said that Medicare will remain solvent until 2029, allowing the program to forestall triggering an Affordable Care Act provision to convene the Independent Payment Advisory Board.

On Wednesday, the US House of Representatives passed the FDA Reauthorization Act of 2017 (FDARA), which, among other provisions, reauthorizes user fees for biosimilar product applications. The bill, sponsored by Representative Greg Walden (R-Oregon), was passed by a voice vote.

To gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences for the content of biosimilar labels, a multi-stakeholder workshop was held in Brussels, Belgium.

Last week, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruled to invalidate AbbVie’s patent on a method of treating rheumatoid arthritis using adalimumab (Humira). The PTAB deemed the claims in question unpattentable because of their obviousness.

Treating patients with biosimilars of expensive biologic medications has the potential to reduce the costs of treatment for patients and payers, but the use of biosimilars has not translated into savings for most providers, which limits broader adoption of biosimilars, according to a recent analysis.

On June 29, the Federal Register published the FDA’s request for comments concerning its statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original 351(k) Biologics License Applications.

The UK government sought to reassure citizens this week that “Brexit,” or the United Kingdom’s withdrawal from the European Union (EU)—and therefore its withdrawal from the European Medicines Agency (EMA)—would not negatively impact patient access to pharmaceuticals.

The expectation of achieving potentially significant health-system cost savings stemming from competition among an increasing number of available biosimilars has led to widespread interest in developing modeling techniques that can accurately estimate the economic impact of biosimilar adoption.

A bipartisan bill, introduced by US Senators Chris Coons (D-Delaware), Tom Cotton (R-Arkansas) Dick Durbin (D-Illinois), and Mazie Hirono (D-Hawaii), seeks to make a number of reforms that would make it easier for innovators—including the manufacturers of reference biologics—to defend against challenges to their patents.

A survey and drug utilization analysis conducted among UK healthcare professionals found that 75% of respondents were aware that biosimilars were available on their local formularies, and 77% considered biosimilars to be either extremely or very important to save costs for the National Health Service.

As of July, 2017, 33 US states and Puetro Rico have enacted laws concerning biosimilar substitution.

The Biosimilar User Fee Act of 2012, which authorized the FDA to collect fees from biosimilar drug manufacturers to expedite their applications, is due to expire at the end of September.

The 52 comments the FDA received during the public commentary period on the agency’s January 2017 draft guidance, Considerations in Demonstrating Interchangeability With a Reference Product, included statements from physicians concerned about the proposed policy.

The United Kingdom's National Institute for Health and Care Excellence (NICE), which provides value guidance to the National Health Service, has published its final appraisal determination for baricitinib (Olumiant), a Janus kinase inhibitor, recommending use of the drug as an option for treating severe active rheumatoid arthritis.

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of June 26, 2017.