News

Health literacy was categorized as problematic in 36.2% of patients and insufficient in 15.1%.

The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.

Economic evaluations of biosimilar disease-modifying antirheumatic drugs (DMARDs) suggest cost-effectiveness for patients with rheumatoid arthritis (RA) who did not respond well to methotrexate, potentially improving patient outcomes and health care affordability.

Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.

Jeffrey Casberg, MS, RPh, senior vice president of pharmacy at IPD Analytics, highlights new FDA approvals, the launch of the first tocilizumab biosimilar, and how pharmacy and therapeutics committees approach new pipeline drugs.

A long-awaited report from the Federal Trade Commission (FTC) finds that vertical integration and consolidation have worked against consumers and independent pharmacies.

Here are the top 5 biosimilar articles for the week of July 8, 2024.

Patients with HER2-positive breast cancer treated with the biosimilar trastuzumab-dkst experienced similar adverse events and well-being as those treated with the originator drug (Herceptin), according to a study using a smartphone app to track symptoms.

The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.

A Brazilian real-world study found trastuzumab-dkst to be an effective and safe adjuvant therapy for HER2-positive (HER2+) breast cancer, with clinical outcomes comparable to reference trastuzumab.

The author, who is CEO of Pontchartrain Cancer Center, discusses how biosimilars can be part of a strategy for delivering high-quality care while achieving savings.

On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.

A phase 1 study demonstrated pharmacokinetic (PK) bioequivalence of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the EU- and US-sourced reference products.

Here are the top 5 biosimilar articles for the week of July 1, 2024.

As Celltrion publishes phase 3 data on its tocilizumab biosimilar, other companies finalize partnerships, and Formycon begins development for a pembrolizumab biosimilar.

As the weather heats up for the US and Europe, so too did the biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.

The FDA has approved Ahzantive (aflibercept-mrbb) as the third biosimilar referencing Eylea (aflibercept) for the treatment of eye conditions, including age-related macular degeneration.

Pyzchiva (ustekinumab-ttwe) is the third ustekinumab biosimilar to receive approval for the American market. It was also approved with interchangeability.

Sarfaraz K. Niazi, PhD, champions the FDA's updated guidance to remove switching study data for companies seeking to obtain an interchangeability designation for their biosimilars.

In an interview with Jeffrey Casberg, MS, RPh, he discusses 3 promising specialty drugs coming through the pipeline. Casberg explains these drugs offer new treatment options for major diseases and stakeholders should watch for their potential impact on the market.

Two phase 3 trials in patients with inflammatory bowel disease (IBD) found higher clinical remission rates in those treated with the subcutaneous formulation of infliximab biosimilar CT-P13 compared with placebo as maintenance therapy following an induction phase of intravenous CT-P13.

Here are the top 5 biosimilar articles for the week of June 24, 2024.

Two posters presented at the European Hematology Association’s annual meeting (EHA 2024) evaluated how rituximab biosimilars impact quality of life and infusion-related reactions in patients with lymphatic cancers.

Lack of knowledge and confidence in biosimilars continues despite growing education efforts, impacting provider willingness to prescribe biosimilar medicines and patient perceptions about their treatment and switching to a biosimilar.

Authors of a commentary piece propose solutions to sustainability issues for biosimilar markets and shed light on common sustainability challenges global markets face.

Two posters from the American Society of Clinical Oncology (ASCO) annual meeting look at Medicare reimbursement trends for originator and biosimilar biologics, as well as a combination therapy utilizing a pegfilgrastim biosimilar in patients with advanced hepatocellular carcinoma.

Jeffrey Casberg, RPh, MS, from IPD Analytics, explains why he believes policy changes and market forces are impacting the cost of drugs, including the Inflation Reduction Act (IRA) and pharmacy benefit manager (PBM) legislation.

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.