The biosimilar market is headed for a fork in the road, and the road taken will lead to savings and access or less competition and stiffer regulation.
Kashyap B. Patel, MD, has worn many hats in the struggle to broaden biosimilar access. He is an independent oncology practitioner, a member of the Community Oncology Alliance (COA), and a representative of International Oncology Network (ION) Solutions, a large drug purchasing organization. Bringing biosimilars to a broader population of patients has involved negotiations with payers, persistence on Capitol Hill, and education, he explains in an interview.
Although the totality of the evidence is reassuring, the jury is still out on nonmedical switching to biosimilars, according to new study results.
There are several pending legislative proposals in both the House of Representatives and the Senate designed to encourage more commercialization of biosimilars, but the 2020 election may determine their timing.
Intellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).
Julie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.
Four pharmacists offer advice for clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.
The approval of Biocon Biologics and Viatris' insulin glargine product as an interchangeable biosimilar will be a test of whether such designations can make a difference in patient access, Jeff Baldetti, MBA, of Cardinal Health explains.
Intellectual property law attorneys from Axinn discuss regulatory and legal events in 2020 that will affect biosimilar markets in 2021.
Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.
Four pharmacists offer advice for clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.
In this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.
Jeff Patton, MD, CEO and board member at OneOncology, dived into the controversial role that pharmacy benefit managers (PBMs) play in formulary decision-making and how PBMs impact biosimilar utilization.
Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.
In his comeback column, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores the world of biobetters and the complicated dynamics surrounding the FDA approval of Zymfentra, the first subcutaneous infliximab.
Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.
In this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.
In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. However, biosimilars have also encountered the harsh realities of the US health care system and its market forces.
As new biosimilars are added to CVS Caremark’s standard formulary, others are removed. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.
Intellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.
The legal and common uses of “interchangeability” continue to be conflated.
The legal and common uses of “interchangeability” continue to be conflated.
Dan Danielson, RPh, MS, senior director, market access solutions, at PrecisionValue, a market access marketing firm, explains the remaining issues at play slowing down biosimilar uptake in the United States.
The Biologics Price Competition and Innovation Act (BPCIA) provides a stepwise approach for fact-finding prior to patent litigation, but companies may choose their own path, case examples show.
The biologics license application (BLA) seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, a biosimilar of Neulasta Onpro, has been resubmitted to the FDA for review.
Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores whether biosimilars should be considered a commodity and if the commodification of medications is sustainable as the market continues to expand.