May 6th 2024
Sarfaraz K. Niazi, PhD, explains FDA's new guidance on promotional labeling as well as challenges and insights into how this new guidance will impact biosimilars.
Journal Publishes Letter on Banning Animal Testing for Biosimilars
July 12th 2022A 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
July 11th 2022Ivo 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
July 5th 2022During 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.
Contributor: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA
June 27th 2022Sarfaraz 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.
After Announcing Global Biosimilar Initiative, Sandoz Sees EU Biosimilar Application Acceptance
June 20th 2022Not 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
June 19th 2022The 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.
Biosimilar Policy Roundup: May 2022
May 31st 2022May 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.
Dr Eric Tichy Calls for Government Officials to Realign Incentives in Favor of Biosimilars
May 18th 2022Altering reimbursement procedures needs to become a bigger priority for government officials to incentivize biosimilar utilization, according to Eric Tichy, PharmD, MBA, vice chair of pharmacy formulary at the Mayo Clinic Health System.
Conference Posters Highlight Real-world Trends of Biosimilars, Reclassified Biologics
May 14th 2022Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting examined the real-world patterns of biosimilar utilization and the impact of products that have been reclassified as biologics on Medicaid spending.
Health IT for Biosimilars Spotlight: Cardinal Health's Decision Pathway
May 10th 2022Amy Valley, vice president of clinical strategy and technology solutions at Cardinal Health, details the company's Decision Pathway, a health information technology (IT) tool that can assist practices with prescribing patients the lowest-cost product, including biosimilars.
Given Public Concerns, Canadian Policy Makers Should Be Cautious When Making New Biosimilar Policies
May 5th 2022A report on biosimilar uptake and existing policies signals that policy makers should proceed with caution when establishing new policies to boost biosimilar utilization and savings, as many patients and providers still have concerns on their usage.
Julie Reed: House Hearing Omitted Biosimilar Issues Despite Growing Need for Solutions
May 4th 2022The main takeaway from the House Energy and Commerce Committee hearing on HHS's 2023 budget was that biosimilars were not mentioned as much as they should have been, said Julie M. Reed of the Biosimilars Forum.
Dr Sarfaraz K. Niazi Claims Biosimilar Growth Signals Need for Greater Testing, Policy Reform
April 28th 2022Now that the United States’ acceptance of biosimilars matches that in the European Union, developers should be encouraging changes to testing regulations to increase biosimilar accessibility, according to Sarfaraz K. Niazi, PhD, in his recent perspective paper.
Opinion: Biosimilar Adoption Will Help Achieve a Bipartisan Goal
April 25th 2022Biosimilars provide significant savings and encourages competition in the biopharmaceutical marketplace but the United States needs to do more to empower uptake and address adoption barriers, according to Robert Popovian PharmD, MS.
Prioritizing Reference Products Over Biosimilars Led to Millions in Missed Savings for Part D
April 20th 2022Medicare Part D plans missed out on between $84 million and $143 million in savings by not prioritizing the use of biosimilars over reference products, according to a report from the HHS Office of Inspector General.
Dr Edward Arrowsmith Discusses Clinical Pathways, Biosimilars in Ensuring Quality of Care
April 5th 2022Edward Arrowsmith, MD, discussed his recent paper on the use of clinical pathways for specific cancer types and how biosimilar development can help ensure quality of care for patients with limited therapeutic options.
Jeffery Casberg Previews His Presentations at AMCP 2022
March 27th 2022Jeffrey Casberg, vice president of pharmacy at IPD Analytics, previews his sessions about the new and emerging pharmaceutical products coming down the pipeline at the upcoming Academy of Managed Care Pharmacy (AMCP) annual meeting.