Policy

The Center for Biosimilars® recaps the top news for the week of May 27, 2019.

The Biosimilars Forum said this week that if Congress enacted certain changes, the federal government and beneficiaries could save billions of dollars in Medicare Part B.

The House of Representatives has passed HR 965, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES Act), as well as 2 other bills dealing with drug prices: HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, and HR 938, the Bringing Low-cost Options and Competition While Keeping Incentives for New Generics (BLOCKING) Act of 2019.

A new Federal Trade Commission (FTC) staff report has found that, despite an increase in patent settlements concerning generic drugs, fewer settlements included the kinds of “pay-for-delay” provisions that are likely to be anticompetitive in nature.

Officials in British Columbia announced on Monday that patients currently taking reference biologics for rheumatological diseases and diabetes will be switched to biosimilar products within 6 months.

Another piece of bipartisan legislation was introduced last week that seeks to promote biosimilars.

This week, Colorado Governor Jared Polis, D, signed the nation’s first bill that will cap insulin co-pays at $100 per month for people with health insurance.

Yesterday, the Senate Committee on Health, Education, Labor, and Pensions released bipartisan draft legislation aimed at lowering the cost of healthcare in the United States.

The Center for Biosimilars® recaps the top news for the week of May 20, 2019.

Europe has several lessons for the US biosimilar market, according to a pharmaceutical executive who spoke during ISPOR 2019.

During the ISPOR 2019 annual meeting, teams of investigators presented data estimating just how much healthcare systems could save by adopting biosimilar adalimumab for all indications of its reference in adult patients. The results highlighted both the scale of potential savings and the variability among European nations.

Last week, CMS issued a final rule that makes changes to Medicare Advantage and Medicare Parts D and B.

With the expanded use of step therapy on the horizon in 2020, an advocacy initiative of rheumatology, arthritis, and gastroenterology and other associations recently released a report “grading” payers and pharmacy benefit managers (PBMs) for the extent of their prescription coverage of medications for patients with autoimmune disorders.

The bill codifies definitions of product hopping and patent thicketing within the Federal Trade Commission (FTC) statute, allowing the FTC to challenge these practices as anticompetitive and to enable the FTC to bring antitrust suits against drug companies.

During the Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, a specialist pharmacist for a large National Health Service healthcare trust explained how the transition to biosimilars worked at a practical level in the UK home care system, and shared lessons learned from the experience.

During the Biosimilars Commercialisation Summit 2019, held May 14-15 in Amsterdam, the Netherlands, among the key topics of discussion was the sustainability of the world’s healthcare systems and the need to create savings in order to continue to advance the treatment of cancer and chronic diseases.

Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.

Cost-effectiveness models for the treatment of rheumatoid arthritis (RA) first emerged in the early 2000s when highly effective but also high-cost biologic therapies began to reach patients. However, these health technology assessment (HTA) models need improvement, a recent paper says.

In 2018, The Generic Biosimilar Medicines Association (GBMA) was awarded the Biosimilar Education Grant by the Australian government to develop an educational program for Australian stakeholders with the aim of increasing confidence in biosimilars that are listed on the nation’s public drug benefit plan. Now, the GBMA has launched an educational hub.

The bill seeks to prohibit brand-name drug makers from delaying the entry of generics or biosimilars by compensating competitors to keep their products off the market for a period of time in so-called pay-for-delay arrangements.

The Center for Biosimilars® recaps the top news for the week of May 6, 2019.

The House of Representatives has passed a pair of bills that make changes to the FDA’s Orange Book and Purple Book, which provide information on generic drugs and biosimilars, respectively.

In an effort to improve price transparency, the Trump administration on Wednesday announced a final rule requiring drug manufacturers to disclose their list prices for pharmaceutical products or biologics in television ads for drugs covered by Medicare or Medicaid if the wholesale acquisition cost is $35 or more for a month’s supply. Affected drugs include adalimumab (Humira), with its wholesale acquisition cost (WAC) of $5174 per month, and etanercept (Enbrel), with its WAC of $5174 per month.

This March, the FDA released updated guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. In the document, the FDA indicated that it no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, but it will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. In addition, FDA does not intend to add suffixes to the names of transition products. This week, the comment period on the updated guidance closed, and the FDA heard from a variety of stakeholders who asked the agency to change its direction.

The idea of giving the Federal Trade Commission (FTC) more authority to cut through patent thickets blocking biosimilar competition was raised Tuesday during a hearing of the Senate Judiciary Committee about intellectual property, patent law, and the impact on drug prices.

With additional biosimilars expected to reach the market later this year and beyond, Canada has made another move to foster biosimilar adoption with 2 recent developments.

The Congressional Budget Office this week released a report that examines the different components of what putting together a single-payer system could involve, as well as the implications. Here we highlight 2 sections of the report that are likely of interest to those following biosimilars, drug pricing and healthcare cost containment.

European elections will take place later this month, allowing EU citizens to select their representatives in the European Parliament. The elections, being held for the first time in 5 years, are particularly significant to the healthcare sector as European stakeholders seek to reduce disparities in access to care, guard against drug shortages, and ensure a sustainable market for pharmaceuticals.

“The path forward requires a sustainable, fair payment system in which drug prices reflect the value provided and reward innovations that improve outcomes,” wrote Robert M. Califf, MD, and Andy Slavitt.

The Center for Biosimilars® recaps the top news for the week of April 22, 2019.