Rheumatology

CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.

An analysis of subcutaneous biosimilar and originator tumor necrosis factor (TNF) inhibitors for rheumatic diseases found no significant differences in survival or discontinuation rates due to inefficacy or adverse events, with biosimilars showing lower overall discontinuation rates and higher retention rates.

Manitoba’s new policy means that all 10 Canadian provinces now have an initiative to boost biosimilar adoption and savings by transitioning patients on reference agents to biosimilar options.

Products in line to face biosimilar competition are projected to increase their list prices in advance, according to Vizient’s Pharmacy Market Outlook Report for Summer 2024.

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.

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.

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

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

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

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.

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.

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.

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.

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.

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.

Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.

At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.

A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.

The FDA approved a high-concentration, citrate-free version of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), making it the second high-concentration adalimumab biosimilar to have an interchangeability designation.

The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.

A review article summarized the totality of evidence supporting the approval of the adalimumab biosimilar GP2017 (Hyrimoz; Sandoz) in the United States and Europe.

In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.

Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.

Tyenne (tocilizumab-aazg) was the second tocilizumab biosimilar to be FDA approved, but it is the first to launch in the US.

Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.

A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.

After poor sales for its adalimumab biosimilar, Boehringer Ingelheim (BI) announces layoffs; Teva Pharmaceuticals and mAbxience partner on an oncology biosimilar; Samsung Bioepis begins a phase 3 trial for a biosimilar referencing Keytruda (pembrolizumab).