Policy

Despite earlier White House statements indicating that the Trump administration would ask the FDA to generate 100% of its program funding through user fee programs, on August 18, the President signed the FDA Reauthorization Act of 2017 (FDARA) into law.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 14, 2017.

While the FDA appears to be taking a more active role in leveraging its position to influence drug prices, the majority of efforts to bring down pharmaceutical costs are taking place at the state level.

Although the use biosimilar infliximab in rheumatoid diseases and inflammatory bowel disease has the potential to reduce the treatment costs, a variety of factors may influence the adoption of biosimilar treatments and their potential impacts on healthcare budgets.

The European Medicines Agency announced this month that it has initiated a business continuity plan to cope with the political uncertainty and the workload implications of the United Kingdom’s impending withdrawal from the European Union.

Ireland’s Minister for Health has published a consultation paper on overhauling the nation’s approach to biosimilar medicines. The paper indicates that the Irish government is developing a National Biosimilar Medicines Policy “to promote the rational use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.”

In 2014, Germany had the highest use of biosimilars in Europe, with around 50% volume uptake. Yet data found that German patients have shown some reluctance to accept biosimilars.

Roche has withdrawn its Special Leave Petition (SLP) filed in India’s Supreme Court against a March 3 High Court decision to allow Biocon and Mylan to use the Swiss drug maker’s product data for their trastuzumab biosimilar.

Insurers operating in the Affordable Care Act marketplace face fresh uncertainties as they plan for 2018: whether Congress will continue in its efforts to repeal or replace the ACA, whether the Trump administration will enforce the individual mandate, or even whether the federal government will continue to pay insurers for cost-sharing reductions are all unanswered questions.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 7, 2017.

The US Court of Appeals for the Federal Circuit today dismissed Amgen’s appeal of a previous district court ruling that denied its motion to compel discovery from Hospira in a Biologics Price Competition and Innovation Act (BPCIA) litigation.

FDA Commissioner, Scott Gottlieb, MD, has created a new FDA working group of senior agency staff who will investigate ways to increase generic drug competition.

The US Supreme Court’s recent ruling in the case of Sandoz v Amgen led to industry speculation that biosimilar applicants could lack incentive to participate in the information exchange process with reference product sponsors, or the so-called “patent dance,” provided for under the Biologics Price Competition and Innovation Act (BPCIA).

Kyle F. Skiermont, PharmD, COO of Fairview Pharmacy Services, spoke with The Center for Biosimilars® about his experience with payers and providers as they prepare for the impact of biosimilar drugs and possible non-medical switching.

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.