Policy

Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same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.

Alberta became the most recent Canadian provincial government to mandate a nonmedical switch to biosimilars for certain patients on taxpayer-funded drug plans.

An agreement on the United States–Mexico–Canada Agreement (USMCA), a trade deal that updates the North American Free Trade Agreement, has been reached, and proponents of biosimilars and generics have cause to celebrate after the removal of provisions that some said would hinder competition.

Trade representatives for Canada and Mexico met last week over the ratification and implementation of the United States–Mexico–Canada Agreement (USMCA), and press reports say that the Trump administration is considering acceding to Democrats’ demands to reduce patent protections for reference biologics in order to get the pact through Congress.

HR 3 proposes targeting for negotiation those drugs that consume a large share of the healthcare budget and that have limited biosimilar or generic competition. Writing in a perspective article in The New England Journal of Medicine, Peter B. Bach, MD, MAAP, a noted critic of high drug prices, proposed a different set of targets.

With debate and argument over what is to blame for high drug pricing, this report sought to examine the executives’ reasoning and attitudes behind pricing decisions.

The European Commission has released a new report that highlights the role that biosimilars and generics will have in the wellbeing of European healthcare systems in the years ahead.

Universal access to affordable essential medicines remains an unmet goal, and while the World Health Organization has been attempting to address this problem through prequalification of drugs like insulin to help ensure access for patients in low-resource areas, costs for many products remain prohibitive.

The issue of whether to switch patients currently taking biologics to biosimilars has been playing out in Canada over the past week, as mandated switching begins in British Columbia, while a reference product maker fights against a possible similar change in 2 other provinces.

How much does the price of common drugs vary across the globe? A UK digital healthcare startup collected that information to display the disparities across 50 countries for 13 often-used pharmaceuticals, including adalimumab and insulin glargine.

Based on the number of bills coming through Congress, it is clear that biosimilars have become synonymous with decreasing healthcare costs. Even with only a few biosimilars commercially available thus far, the federal push towards these drugs has been pronounced.

President Trump’s choice to lead the FDA faced some questions, but not many, about drug pricing, according to various press reports about the Senate committee hearing Thursday regarding the nomination of Stephen Hahn, MD, FASTRO, the chief medical officer of MD Anderson Cancer Center.

With more choices available in 2020 for Medicare stand-alone Part D drug plans, beneficiaries should compare choices, especially if they are not low income or on specialty drugs or drugs not on the payer’s formulary, according to a new analysis.

The AARP Public Policy Institute has released a new Rx Price Watch report showing that, last year, the retail prices of 267 brand-name drugs that are commonly used by older Americans rose by an average of 5.8%—more than twice the general rate of inflation, which was 2.4%.

A House subcommittee voted unanimously Thursday to send a bill intended to stop sham citizen petitions from clogging the FDA’s approval process for generic drugs under the section 505 pathway to the full Energy and Commerce Committee.

The Center for Biosimilars® recaps the top stories for the week of November 11, 2019.

Organizations reacted this week to news that CMS is raising Part B premiums with a variety of opinions, as CMS blamed rising drug prices for the increase.

Postmarket drug price changes alone accounted for most of the recent spending growth on biologics, and manufacturers’ rebates had little impact, according to an abstract presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, this week.

Today in the European Union, we can be proud and celebrate the fact that in 28 EU Member States, biosimilar medicines are in use, and competition in the biological medicines field has consistently brought value for patients and healthcare communities. In general, broader access (more patients treated) is an immediate consequence of biosimilar competition, and earlier access to treatment (where clinically appropriate) has been observed in a number of countries.

The high cost of healthcare is putting a strain on employers who provide health insurance coverage to their employees, and prescription drug prices are now front and center in the push to make coverage more affordable to provide to American workers.

Among all respondents, 53% of beneficiaries reported having had a serious problem paying a medical bill of any kind. Thirty percent of respondents said prescription drugs created the largest burden.

During the International Society for Pharmacoeconomics and Outcomes Research 2019 meeting being held in Copenhagen, Denmark, 3 teams of researchers presented findings that show that, despite the fact that Europe’s biosimilars market is far more mature than that of the United States, the region still sees setbacks from stakeholder perceptions of biosimilars and from policies that do not adequately incentivize biosimilar use.

The Center for Biosimilars® recaps the top stories for the week of October 28, 2019.

A bipartisan bill introduced in the Senate this week aims to address the growing issue of drug shortages.

The American Society of Clinical Oncology (ASCO) today released its third annual National Cancer Opinion Survey, results of which highlight the added stress that the financial burden of treatment places on patients with cancer.

A bipartisan bill to require patent transparency in an effort to bring down the cost of prescription drugs has been introduced in the House of Representatives; the bill is a piece of companion legislation to one introduced in the Senate in March.

Republicans in the House of Representatives this week laid out their alternative to the Affordable Care Act (ACA) in an effort to position themselves against various Democratic healthcare proposals. The document contains many ideas that have been debated previously when Republicans tried to repeal the ACA, and it draws on work from the Heritage Foundation and the Cato Institute.

While some data suggest that overall drug price increases may have moderated recently, prices for specific drugs continue to rise at rates above inflation.