December 4th 2023
Sarfaraz K. Niazi, PhD, comments on a poll he conducted revealing that many are still hesitant to remove clinical efficacy study requirements for biosimilars in his latest column.
December 2nd 2023
A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.
November 28th 2023
Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
November 23rd 2023
The legal and common uses of “interchangeability” continue to be conflated.
November 20th 2023
Sarfaraz K. Niazi, PhD, offers hope for the end of interchangeability labels in the United States in his latest column.
Biosimilars Policy Roundup: October 2022
October ushered in a number of policy updates, including the implementation of a biosimilars switching policy, the European Union declaration of biosimilars as interchangeable, and the reauthorization of the Biosimilars User Fee Act.
Dr Ryan Haumschild: What Health Systems Can Learn From Emory Healthcare's Biosimilar Strategy
Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, offers advice to health systems on how they can incorporate some of Emory Healthcare's strategies to promote biosimilar uptake.
Saskatchewan Becomes Sixth Canadian Province to Implement a Biosimilar Switching Policy
Saskatchewan joined 5 provinces and 1 territory in implementing a biosimilar switching policy, allowing for reference products to be switched out for biosimilars and lowering drug costs for the province’s public health plan.
Biden Authorizes Update to the Biosimilar User Fee Act Through 2027
After months of pressure and calls for action, President Biden reauthorized the Biosimilar User Fee Act, which will allow the FDA to assess and collect fees for biosimilars for the next 5 years.
Amgen Report: Biosimilars Have Saved $21 Billion in 6 Years
Amgen’s ninth edition of its Biosimilar Trends Report explores the evolution of the US biosimilar industry, including current trends, predictions for the next few years, advice for stakeholders going forward, and insight into how reimbursement and other policies could develop.
Advocacy Organization Calls for Ontario to Switch Patients to Biosimilars
Biosimilars Canada, a national association representing the Canadian biosimilar industry, held a press conference calling on Ontario, the province containing the nation’s capital, to institute a biosimilars switching policy.
Dr Ryan Haumschild Compares Viewpoints on Biosimilar Value Between Stakeholders
Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, explains how stakeholders may view the economic value of biosimilars differently based on their goals and his predictions for how biosimilar utilization will develop in the future.
Biosimilar Medicare Part B Payment Boost Begins
Under the Inflation Reduction Act, there is a 5-year temporary increase in the add-on payment for qualifying biosimilars whose average sales price (ASP) is not more than the price of the reference product.
BioRationality: a Dr Sarfaraz Niazi Column—The EMA Declares Biosimilars Interchangeable
Sarfaraz K. Niazi, PhD, explains the significance of the European Medicines Agency (EMA) declaring that biosimilars are interchangeable with their reference products and calls for the United States to do the same in the first installment of his new monthly column.
Part 4: How Payers Can Prepare for Adalimumab Biosimilars
The final part of this 4-part series assesses what payers should know about the US introduction of adalimumab biosimilars coming in 2023 as well as policy consideration they can implement to reap the benefits of biosimilar savings.
How Health Policy Can Impact Adoption for Adalimumab Biosimilars
In this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, discussed current policy initiatives that could help biosimilar adoption and how the Inflation Reduction Act is expected to influence the adalimumab market.
Contributor: Interchangeability Is a Dispensing Issue, Not a Prescribing One
As more biosimilars are granted interchangeability status, 2 representatives from Samsung Bioepis stop misinformation in its tracks by clarifying that the designation will primarily impact pharmacy dispensing instead of prescription habits.
Getting Rid of Clinical Efficacy Testing for Biosimilars Is Needed, Ethical
In a recent paper, Sarfaraz K. Niazi, PhD, argues that getting rid of clinical efficacy testing for biosimilars could realign testing ethics with current guidelines, save companies money on development, and improve data sensitivity.
Upcoming WHO Guideline Changes May Reduce Data Requirements for Biosimilar Development
In advance of the World Health Organization (WHO) updating its guidelines for biosimilar development, a review article concluded that comparative clinical efficacy and safety studies may not be helpful for the evaluation of biosimilars.
Dr Ivo Abraham Column: It's What We Do With the Savings—Economics and Equity
Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, describes the pharmacoeconomics of biosimilars and the savings potential for practices and payers if they prioritize greater biosimilar adoption.
Opinion: The Inflation Reduction Act is a Step Backward for Biosimilar Competition
In response to another opinion piece, Craig Burton, from the Association for Accessible Medicines, argued that the Inflation Reduction Act of 2022 could prevent biosimilar competition, and lower drug prices as a result.
Opinion: Impact of Inflation Reduction Act 2022—Addressing Critics
Sarfaraz K. Niazi, PhD, a professor, entrepreneur, and biosimilar advocate, took aim at criticisms of the Inflation Reduction Act to 2022 that was passed in the Senate and critiques the argument that the bill should be considered a “price control” measure.
Review: Biosimilar-to-Biosimilar Switching Is Safe, Effective
A systematic review found that patients who were switched from one biosimilar to another did not experience a change in clinical outcomes or an increase in adverse events.
$35 Insulin Cap for Private Sector Blocked From Budget Reconciliation Bill
While efforts to cap monthly insulin costs for Medicare patients at $35 survived a budget reconciliation bill in the Senate, Republicans blocked the measure from extending to the private sector.
Journal Publishes Letter on Banning Animal Testing for Biosimilars
A letter penned by Sarfaraz K. Niazi, PhD, advocating for the banning of animal testing requirements for biosimilar development was published in Science, suggesting the journal has softened to the idea that animal testing may not be as useful as originally thought.
Contributor: Good Bait and Fair Switch—Biosimilar Interchangeability, Substitution, and Choice
Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explains the difference between biosimilar interchangeability and substitution and weighs in on whether switching studies are necessary.
Medicines for Europe Recommends Off-Patent Drugs to Strengthen European Health Systems
During its annual conference in Sitges, Spain, Medicines for Europe recommended policy reforms for strengthening European health systems, including the use of off-patent medications like biosimilar and generic drugs.
Consulting With Clinical Pharmacists May Help Boost Biosimilar Adoption
Having patients meet with a clinical pharmacist before a rheumatologist could help improve biosimilar adoption rates and mitigate the nocebo effect in patients with chronic diseases, according to a recent study.
Contributor: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA
Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicles the current efforts to remove animal testing from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.
CHMP Gives Thumbs Up for Celltrion, Formycon Biosimilars
The European Committee for Medicinal Products for Human Use (CHMP) recommended 2 biosimilars for approval: Celltrion Healthcare’s bevacizumab candidate and Formycon’s prospective ranibizumab product.
After Announcing Global Biosimilar Initiative, Sandoz Sees EU Biosimilar Application Acceptance
Not long after the company announced its new global initiative to promote access and increase adoption of biosimilars, Sandoz’ biologics license application for its high-concentration adalimumab biosimilar was accepted by the European Union’s regulatory agency for review.
Julie Reed: Biosimilar Policies Legislators Should Be Prioritizing
The Biden administration must follow through on its promises, and Congressional leaders must do more to push through bipartisan biosimilar policies to encourage better adoption and lower drug costs, according to Julie M. Reed, the executive director of the Biosimilars Forum.
FTC Inquiry Into PBMs to Include a Look at Specialty Drug Lists
The Federal Trade Commission (FTC) will require the 6 largest pharmacy benefit managers (PBMs) to submit records and answer questions regarding their business practices.
Biosimilar Policy Roundup: May 2022
May brought a number of biosimilar policy updates of all types, including updates on British Columbia's switching program, a new bill that could revamp biosimilar user fee programs, and insight into how companies are shaping their environmental policies around biosimilars.
Health Services Utilization Following Mandatory Switching to Infliximab Biosimilar in British Columbia
A study assessing the impact of mandatory switching policies in British Columbia on patients with rheumatic conditions receiving infliximab therapy found that switching to a biosimilar did not result in increased health service use.
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