Biosimilars

In the second part of a 2-part preview interview in advance of this year’s virtual 2020 Community Oncology Conference, The American Journal of Managed Care® speaks with Cheryl Larson, president and chief executive officer of the Midwest Business Group on Health, about how she is helping employer organizations navigate their pharmacy benefits managers and manage employee expectations.

AHIP wants the FDA and FTC to streamline product approvals, clarify the regulations governing biosimilars, put a stop to attempts to discourage people from using biosimilars, and start educating providers and patients about the safety and efficacy of these products.

Private and public institutions are trying to secure supplies of drugs and pharmaceuticals amid travel restrictions and border controls imposed by coronavirus disease 2019 (COVID-19).

The Community Oncology Alliance (COA) said it is worried that the safety of patients with cancer will be compromised if home infusion regulatory changes, brought about by the coronavirus disease 2019 (COVID-19) pandemic, expand; other groups support the changes, which affect Medicare patients using Part B drugs.

Payers view the National Comprehensive Cancer Network (NCCN) guidelines as a gold standard for making reimbursement decisions, according to a panel of experts who spoke recently about biosimilar uptake.

The analysis looked at 13 of America’s largest employers, including energy, hospitality, retail, transportation, and finance companies.

The introduction of biosimilars in the US market brings along specific challenges to health system pharmacists, including formulary assessment, implementation, and education of patients and various health system stakeholders, according to a review published in Drugs In Context.

China’s biosimilar development engine is supercharged and running on octane, a recent report said.

Clinical trials for biosimilars and other agents are likely to slow down, if not stall, as coronavirus disease 2019 (COVID-19) wends its course, according to a UT Health expert.

This week, the top managed care news includes a $2 trillion package to address economic damage from coronavirus heads to President Trump, a regulatory change could change the fortunes for biosimilars, and the world’s biggest cardiology meeting goes virtual.

An expert panel discussed the systemic and policy barriers to the uptake of biosimilars.

The speed and extent of biosimilar penetration differ across provider types. Provider awareness and incentives are significantly associated with biosimilar uptake.

The FDA called it “a historic day” as insulin and certain other biologic drugs transitioned to a different regulatory pathway.

The FDA Tuesday cleared a new dose of Samsung Bioepis’ trastuzumab biosimilar Ontruzant, which is yet to be launched in the United States. The approval is for a 420-mg multidose vial of Ontruzant. The biosimilar was first approved as a 150-mg single-dose vial by the FDA in January 2019 across all indications for the reference product, Herceptin.

Giving statins to women before they undergo treatment for breast cancer may help prevent the heart damage caused by some well-known therapies, including trastuzumab.

https://www.pharmacytimes.org/on-demand/managed-care-considerations-for-navigating-biosimilar-and-her2-directed-therapies-for-the-treatment-of-her2-positive-breast-cancer

The Patent Trial and Appeals Board delivered a setback to Gilead Sciences, rejecting its attempt to invalidate a pair of Truvada patents owned by the CDC; Merck is spinning off some businesses in order to focus on its oncology drug pembrolizumab, including its biosimilars operations; Republican and Democratic governors are worried that a proposed CMS fiscal accountability rule for Medicaid will reduce access to healthcare.

Results for Truxima, recently launched in the United States, and complement inhibitors were presented at the 61st American Society of Hematology Annual Meeting and Exposition.

As part of our anniversary celebration, today we launch “Paper of the Week,” which will look back at some of the most influential research articles and commentary that have appeared in The American Journal of Managed Care® over the past 25 years, and why they are important today.

The biosimilar candidate treats paroxysmal nocturnal hemoglobinuria, a rare blood condition that features destruction of red blood cells, thrombosis, and impaired bone marrow function.

The availability of biosimilars introduces competition based on price, offering a lower-cost alternative in the short term and helping to restrict—or even reverse—longer-term price growth.

More than 7 months after Scott Gottlieb, MD, resigned from his position as FDA commissioner, the Senate confirmed Stephen Hahn, MD, FASTRO, to be the next head of the agency.

Lee Schwartzberg, MD, FACP, executive director, West Cancer Center, discusses the importance of working with physicians to make sure they're comfortable prescribing biosimilars.