Posters presented by Alvotech at 2023 American Academy of Dermatology (AAD) annual meeting showcased proven bioequivalence and therapeutic equivalence candidate biosimilar AVT04 and reference ustekinumab (Stelara).

Representatives from Magellan Rx Management provided a detailed overview of current treatment options in ophthalmology and the impact that biosimilars could have during a session at AMCP 2023.

A review of real-world studies assessing patient-reported outcome measures of patients with rheumatoid arthritis (RA) found that although clinical outcomes were similar, patients taking a biosimilar were found to have higher discontinuation rates, possibly as a result of the nocebo effect.

In the wake of adalimumab biosimilars hitting the US market, Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health, hyped up the current biosimilar market trends and the other products coming down the pipeline during her talk at the Festival of Biologics.

At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on biosimilar-to-biosimilar switching, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.

Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).

At the Festival of Biologics, Juliana (Julie) Reed, executive director of the Biosimilars Forum, warned that without changes to encourage biosimilar uptake, companies will begin to ask the big question: Are biosimilars worth investing in?

At the American Academy of Dermatology annual meeting, Samsung Bioepis shared positive results from a phase 1 study comparing its ustekinumab biosimilars (SB17) with the reference product (Stelara).

On this episode of Not So Different, Mark Guyot, senior director of unity provider engagement at McKesson, gives an overview of McKesson’s real-world analysis of community oncology practices and their use of biosimilars and offers advice on overcoming adoption barriers and expanding education efforts.

More and more women are becoming pregnant while on anti–tumor necrosis factor (TNF) biosimilars used to treat inflammatory disorders. However, there is “little data” on the safety and effectiveness of biosimilars in pregnancy, according to authors of a recent retrospective study.

In an article published in Frontiers in Pharmacology, researchers made recommendations to improve the biosimilar regulatory system and refine biosimilar guidelines in China.

In a report from CVS Health, interchangeability will not be a primary factor in driving the adoption of adalimumab biosimilars referencing Humira, contradicting predictions from other sources that believe the designation will impact prescribing habits.

The FDA's new artificial intelligence (AI)-based modeling on characterizing protein aggregation could directly impact the safety assurance of biosimilars and other therapeutic proteins.

Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.

Increasing the use of biosimilars in Belgium will require realigning financial incentives and providing more information to medical professionals, according to authors of a study that proposed policy recommendations.

Comparable safety and efficacy were found between biosimilar FYB201 compared with reference ranibizumab (Lucentis) for neovascular age-related macular degeneration (nAMD).

A new resource from the National Alliance of Healthcare Purchaser Coalitions aims to help plan sponsors adopt biosimilars into their pharmacy benefit plans.

The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.

A white paper touting biosimilar successes in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars.

In part 2 of this 2-part series, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, continued to examine guidelines from the World Health Organization (WHO) and how they view interchangeability and animal study requirements.

The FDA approved the prefilled autoinjector version of Coherus Biosciences’ pegfilgrastim biosimilar (Udenyca), which will allow for patients at risk of febrile neutropenia to administer a full dose of pegfilgrastim at home.

At the European Crohn’s and Colitis Organisation congress, Celltrion Healthcare shared positive safety and efficacy data on maintenance therapy including its infliximab biobetter allowing for subcutaneous administration, Remsima SC.

On this episode of Not So Different, we chronicle the latest gastroenterology news from February, including several updates on adalimumab and infliximab biosimilars and industry analyses on the utilization of these drugs and patient confidence in gastroenterologists’ recommendations.

Authors of a review of safety results across indications and study designs on the epoetin alfa biosimilar HX575 concluded that HX575 “has repeatedly demonstrated long-term safety” in all approved indications in both clinical trials and real-world studies.

Phase 3 study findings support a proposed natalizumab biosimilar (PB006) as the first biosimilar alternative to reference natalizumab (Tysabri) for treatment of relapsing-remitting multiple sclerosis (MS).