Policy

Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether the PTAB might invalidate more patents concerning dosing and frequency of biologics, as it did with claims 1 to 5 of AbbVie's '135 patent for Humira.

The FDA’s biosimilar pathway has encouraged a robust product pipeline, but the fact that few biosimilar drugs have been approved by the agency thus far means that there is still some industry uncertainty on the FDA’s approach to this class of products.

A recent survey of 588 Canadian patients revealed that many patients had serious concerns about biosimilar substitution.

The development of biosimilars is focused on the minimization of potential differences between the proposed biosimilar and reference product, as well as the establishment of a robust manufacturing process to consistently produce a high-quality biosimilar.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 31, 2017.

The Senate today passed the FDA Reauthorization Act of 2017 (FDARA) in a roll call vote.

Reimbursement remains a substantial concern in the market for biosimilar products, according to Amanda Forys, MBA, director of Xcenda’s Reimbursement Policy Insights consulting team.

A recent survey shows that some patients have greater concerns about automatic substitution of biosimilar products than they do about the high cost of biologic drugs.

An examination of national policies on biosimilars in 10 European Union member states concludes that supply-side policies targeting price can limit biosimilar penetration in the long term, while demand-side policies positively impact biosimilar uptake and are important drivers for biosimilar market penetration.

How will the 35% price discount by Merck/Samsung Bioepis on their infliximab biosimilar, compared with the reference, influence stakeholder uptake?

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.