Biosimilars

Despite their growing prevalence, there is still a lack of biosimilar education amongst stakeholders, said Robert Rifkin, MD, FACP, medical director, biosimilars and associate chair, hematology research, McKesson Specialty Health.

Updates from the annual ASH meeting, December 2018.

A review of thousands of FDA inspection records, recalls, warning letters, and lawsuits showed how drugs that are poorly manufactured or contaminated can reach patients; biosimilars have the potential to deliver substantial savings to the healthcare system, but only insofar as they are adopted and used in clinical practice; Maine’s new Democratic Governor, Janet Mills, ordered the state to implement Medicaid expansion with an executive order, calling for state health officials to make the necessary changes and work with the Trump administration.

The year 2018 was a banner year for biosimilars, with the number of FDA-approved biosimilar products nearly doubling, and with major policy, business, and regulatory developments that moved the biosimilars marketplace forward. Here are 5 of the top developments in biosimilars for the past year, as reported by The Center for Biosimilars®, a sister site of The American Journal of Managed Care®.

The House has passed a bill that would support state efforts to investigate pregnancy-related deaths and research how to prevent future deaths; a column in The New York Times examined 4 specific drug pricing policies and had 3 health policy experts weigh in on what the outcomes of implementing these policies could be; despite the benefits of using biosimilar filgrastim, the United States has lagged behind other countries in adopting the therapy.

https://www.pharmacytimes.org/on-demand/an-american-journal-of-managed-care-supplement-managing-costs-and-advancements-in-biosimilars

Coverage of our peer-reviewed research and news reporting in the healthcare and mainstream press.

A generic competitor to the EpiPen will not cost any less than the version that is already on the market; a new service from Amazon will use machine learning to pull key information from patient records; a new report from the European Commission has noted that generic and biosimilar products will be key to curbing wasteful spending in healthcare.

According to a review published in Cancer Management and Research, biosimilar products present a viable cost-saving tool for providers participating in value-based care programs such as the Medicare Shared Savings Program or the Oncology Care Model.

This week, the top managed care news included the Trump administration giving governors the power to overhaul section 1332 waivers under the Affordable Care Act (ACA); CMS disclosed a breach in the portal that agents and brokers use to assist consumers signing up for health coverage under the ACA; about one-third of all US healthcare payments in 2017 were tied to alternative payment models.

Coverage of our peer-reviewed research and news reporting in the healthcare and mainstream press.

AARP and other groups reacted strongly to reports that the pharmaceutical industry was using efforts to combat the opioid crisis to roll back an agreement to close the coverage gap in Medicare Part D.

It’s been more than 100 days since President Trump and HHS Secretary Alex Azar announced the “American Patients First” drug pricing blueprint. Here are 5 actions the government has taken since its release.

Since biosimilars gained a US approval pathway as part of the Affordable Care Act, these follow-on drugs have been widely seen as a key way to address the problem of high-cost biologic drugs. However, cost savings have been disappointing as only 12 biosimilar products have been approved to date, and just 4 have become commercially available. That’s a reality that led FDA Commissioner Scott Gottlieb, MD, to call the US market for biosimilars “anemic.”

FDA Commissioner Scott Gottlieb, MD, announced the release of the agency’s Biosimilar Action Plan; Philadelphia’s tax on soda and other sweetened beverages has been upheld by the Pennsylvania Supreme Court; a federal judge dismissed a lawsuit by 19 states against the Trump administration over the decision to end cost-sharing subsidies under the Affordable Care Act.

https://www.pharmacytimes.org/on-demand/biosimilars-in-treating-cancer

On June 14, 2018, the Senate Judiciary Committee voted 16 to 5 to report the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act to the Senate floor. Here are 5 key things to know about the proposed legislation.

Coverage of our peer-reviewed research and news reporting in the healthcare and mainstream press.

The National Comprehensive Cancer Network (NCCN)’s 23rd Annual Conference, held March 22-24 in Orlando, Florida, brought together stakeholders from across the oncology landscape. Here are 5 key takeaways from the meeting.

Both Managed Care Cast, from The American Journal of Managed Care®, and Not So Different, the podcast series from The Center for Biosimilars®, offer in-depth discussions of current healthcare issues.

Nine physician groups sent a letter to HHS Secretary Alex Azar Wednesday expressing concern about drug pricing proposals related to Medicare Part B and Medicare Part D that they said would hurt patient care.

This week, the top managed care stories included Cigna's deal to buy Express Scripts; Seema Verma, Alex Azar, and Scott Gottlieb, MD, made the rounds at health conferences; an analysis finds FDA's accelerated approval pathway has been a success with hematology and oncology drugs.

Does meaningful competition currently exist in the pharmaceutical industry and is there enough transparency on price? This was the crux of the discussion at the 2018 National Health Policy Conference of America’s Health Insurance Plans in Washington, DC.

Last week, the European Crohn's and Colitis Organisation held its 13th annual congress in Vienna, Austria. At the meeting, researchers presented new data on using biosimilar anti–tumor necrosis factor therapies in treating Crohn disease and ulcerative colitis, 2 manifestations of inflammatory bowel disease. Here are 5 things to know about the research presented.