Biosimilars

Attendees at an AMCP Nexus 2023 session received an overview of FDA approvals granted in 2023 as well as a preview of nononcology drugs to be released over the next 5 years.

During a session at AMCP Nexus 2023, presenters discussed the delicate balance between cost and innovation as it relates to forthcoming oncology treatments.

Ustekinumab-auub is approved for use in both adult and pediatric populations.

Newly approved by the FDA, Celltrion’s infliximab-dyyb (Zymfentra) offers patients with inflammatory bowel disease a more innovative administrative approach to infliximab treatment.

Lower costs, increased availability, and assistance programs are “game changers” for patients.

Boehringer Ingelheim’s unbranded adalimumab-adbm biosimilar will be available at an 81% discount to adalimumab (Humira).

Matthew Lee, vice president of sales and marketing at MedOne, led a discussion about trends in care management from a PBM and health perspective.

The clinical pharmacist will play an important role as a medication expert, filling in for the role that pharmaceutical manufacturers once did in supporting patients and prescribers.

Sandoz's injection treatment natalizumab-sztn (Tyruko) is the first biosimilar approved by the health agency for the treatment of multiple sclerosis.

Researchers at the 2023 American Academy of Dermatology Association Annual Meeting discussed the effects of product complexity on preclinical testing, among other topics.

The news comes almost 2 weeks after Cyltezo’s entrance into the US biosimilars market as the first commercially available and FDA-approved interchangeable adalimumab biosimilar.

The company will also add Sandoz’s unbranded version of adalimumab to its National Preferred Formulary.

The Humira biosimilar is a tumor necrosis factor (TNF) blocker and was approved by the FDA in 2021.

These medications join adalimumab-atto, which launched on January 31.

Boehringer Ingelheim’s Cyltezo is the first and only FDA-approved interchangeable biosimilar to adalimumab.

Although biosimilars have been introduced with the aim of competing with expensive biologic therapies, their adoption has been more gradual than expected.

A study found that pharmacists possessed moderate to low knowledge scores when it came to statements tackling biosimilars.

The Act4Biosimilars Action Plan aims to highlight key challenges preventing patient access to biosimilars and outline steps to help overcome them.

Hesitation from patients and providers to switch to an infliximab biosimilar may not be necessary, new study finds.

At least 6 adalimumab biosimilars are set to launch in July 2023.

Yusimry (adalimumab-aqvh) is 1 of 9 FDA-approved adalimumab biosimilars and is a low-concentration, citrate-free product.

Years of steady price increases have made access to the essential medicine more difficult for millions of Americans with diabetes.

Juliana Reed, executive director of the Biosimilars Forum, discussed the impact of market dynamics and changing pricing structures during a presentation at the 2023 Asembia Specialty Pharmacy Summit.

88% of surveyed payers said interchangeability will have the biggest impact on adoption.

The Inflation Reduction Act boosted the Medicare payment for biosimilars from the standard average sales price plus 6% to 8%.

As more adalimumab biosimilars are poised to enter the market, manufacturers, payers, and patient advocates are preparing to navigate potentially turbulent waters.

The drug, manufactured by Sandoz, will treat conditions including osteoporosis in postmenopausal women

The new report reviewed the potential impact of biosimilars across multiple specialties.

The launch of Amgen's adalimumab biosimilar Amjevita was just the start of a wave of biosimilars to treat autoimmune diseases.

The Biologics License Application of a proposed biosimilar of denosumab, a drug that could treat several bone diseases and issues, has been accepted by the FDA.