News

Celltrion’s infliximab biosimilar CT-P13 demonstrates similar effectiveness and safety to the originator in biologic-naive patients with Crohn disease in a retrospective, real-world study in Japan.

Here are the top 5 biosimilar articles for the week of July 22, 2024.

Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.

A biosimilar dulaglutide showed similar pharmacokinetic and safety profiles compared with the reference product Trulicity in healthy Chinese participants, according to a phase 1 analysis.

Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.

About half of the patients in a European study who transitioned from reference adalimumab to a biosimilar version stayed on the biosimilar at the 1-year mark. However, researchers warned about a possible nocebo effect resulting in some patients switching back to the originator.

The FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh), marking the second US approval for a biosimilar referencing Soliris (eculizumab).

Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.

Although biosimilars reduce drug purchasing costs for hospitals, it’s unclear whether those savings might be offset by increased health resource utilization following a non-medical switching initiative.

Here are the top 5 biosimilar articles for the week of July 15, 2024.

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.