News

A real-world study using data from the French National Health Data System, found no significant differences in treatment persistence or safety between anti-tumor necrosis factor (TNF)-α biosimilars and reference products in all indications of these biologics.

Here are the top 5 biosimilar articles for the week of June 17, 2024.

The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.

The broader adoption of biosimilar drugs has the potential to significantly reduce cancer care costs and improve patient access to more affordable treatments, benefiting both patients and payers. However, a recent review highlights that biosimilar uptake has been hindered by various economic, practical, attitudinal, and psychological factors.

Part 2 of this series dives into the health care system, revealing financial hurdles that limit biosimilar access and ultimately hinder health equity.

British Columbia's 2019 Biosimilars Initiative, which transitioned over 40,000 patients from costly reference biologics to biosimilars, saved around $732 million in 5 years, maintained comparable health outcomes, and reinvested the savings to improve the province's public payer program.

Sarfaraz K. Niazi, PhD, makes suggestions for what arguments will help convince the FDA to waive clinical efficacy testing requirements for biosimilar approvals.

In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.

Here are the top 5 biosimilar articles for the week of June 10, 2024.

Switching patients with non-infectious uveitis from originator adalimumab to biosimilar adalimumab-atto was safe and effective, but some patients experienced the nocebo effect, where negative adverse events are caused by patients’ poor perception of the drug rather than the medication itself.

A real-world study of children and young adults with inflammatory bowel disease (IBD) switched from the infliximab reference product to a biosimilar concluded effectiveness was maintained over 12 months based on stable remission rates and biochemical markers.

Posters from the American Society of Clinical Oncology annual meeting showcased safety and efficacy data for a trastuzumab biosimilar and an ado-trastuzumab biosimilar in HER2-positive (HER2+) cancers.

Authors of an integrated literature review identified 7 themes that help stakeholders define the value of biosimilar portfolios beyond cost savings, which could provide stakeholders better clarity as to the value of a biosimilar portfolio vs a single biosimilar within a portfolio.

Cencora's Lakesha Farmer, PharmD, MBA, discusses efforts that health care organizations can take to better educate patients and providers on biosimilars to improve biosimilar acceptance and achieve cost savings associated with these products.

Researchers reviewed real-world evidence on the safety and effectiveness of switching from tumor necrosis factor-α inhibitor originators to biosimilars in inflammatory bowel disease (IBD), prompted by mandatory switching policies in most Canadian provinces.

Here are the top 5 biosimilar articles for the week of June 3, 2024.

American and European regulatory agencies have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.

Posters from the American Society of Clinical Oncology (ASCO) 2024 annual meeting demonstrate positive safety and efficacy data for denosumab and pegfilgrastim biosimilars.

In a position paper from the Biosimilars Council, the organization points to evidence showing that clinical efficacy trials are a major barrier to biosimilar access in the US, calling for the FDA to change its policies to remove them in favor of other comparators.

Sarfaraz K. Niazi, PhD, analyzes updates to the FDA's Biosimilars Action Plan, as well as the agency's increased efforts to boost biosimilar adoption and education.

On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.

Posters from Digestive Disease Week 2024 look at how super-responders and pregnant patients with inflammatory bowel disease (IBD) react to treatment with subcutaneous infliximab and an infliximab biosimilar, respectively.

Here are the top 5 biosimilar articles for the week of May 27, 2024.

May proved to be a big month for biosimilar research, particularly in the gastroenterology space, where new data on infliximab and adalimumab products from conferences and journals alike demonstrated positive clinical results showcasing the safety of these products as well as switching to them.

The FDA approved Bkemv (eculizumab-aeeb) as the first biosimilar to Soliris (eculizumab) for 2 rare diseases. It was also approved with interchangeability.

A literature review revealed new data demonstrating that biosimilar-to-biosimilar switching is safe and effective.

Alvotech and Teva have launched Simlandi in the US; Xbrane Biopharma and STADA Arzneimitel partner with Valorum Biologics to bring a ranibizumab biosimilar to the US; Boehringer Ingelheim and Celltrion take steps to expand access to their respective adalimumab biosimilars.

Lakesha Farmer, PharmD, MBA, from Cencora discusses innovative pricing and reimbursement models incentivizing biosimilar adoption and competitiveness, including dual pricing strategies and the Mark Cuban Cost Plus Program, while highlighting potential impacts on patient assistance programs.

A real-world study of the use of adalimumab biosimilars in pediatric inflammatory bowel disease (IBD) in Sicily found “high rates” of clinical remission and treatment persistence, and no unexpected safety concerns.

Here are the top 5 biosimilar articles for the week of May 20, 2024.