News

In his comeback column, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores the world of biobetters and the complicated dynamics surrounding the FDA approval of Zymfentra, the first subcutaneous infliximab.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, reflects on data concerning the potential for adalimumab biosimilars to gain significant market share.

A poster from AMCP Nexus quantifies trends in biosimilar coverage within Tufts Medical Center, finding that payer coverage of these products has increased but individual preferences among payers still vary.

Here are the top 5 biosimilar articles for the week of October 23, 2023.

Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.

As Celltrion releases new data on its subcutaneous infliximab product in gastroenterology conditions, Samsung Bioepis secures an interchangeability designation for Byooviz, making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.

Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.

The FDA approved Celltrion’s Zymfentra (infliximab-dyyb), a novel drug that allows for subcutaneous administration of inflximab.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, discusses why providers need to be wary when deciding whether patients with Crohn disease should switch from Humira (reference adalimumab) to an adalimumab biosimilar.

Here are the top 5 biosimilar articles for the week of October 16, 2023.

Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).

Continuous innovation is required in various technological aspects to effectively manage the challenges of vast clinical data.

Researchers of a literature review found similar safety profiles between biosimilar pegfilgrastim and its reference product (Neulasta) across several phase 1 and phase 3 clinical trials.

Sarfaraz K. Niazi, PhD, chronicles how drug master files (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, shares why his study comparing the safety and efficacy of Cyltezo, an adalimumab biosimilar, with the originator (Humira) matters for patients with gastroenertology conditions.

Prince Edward Island became the eleventh jurisdiction in Canada to implement a biosimilar transition policy, in which patients who are currently taking select reference agents will transition to biosimilar versions.

Here are the top 5 biosimilar articles for the week of October 9, 2023.

An international comparative analysis found that the level of biosimilar market sustainability differs between countries, largely due to variances in biosimilar policies and years of experience managing a biosimilar market.

No safety or immunogenicity differences were found in patients who switched to a biosimilar and those who continued on a reference biologic or biosimilar.

Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.

At EURETINA 2023, Samsung Bioepis shared positive comparative efficacy data on its aflibercept biosimilar candidate, demonstrating that the product is as safe and effective as the originator (Eylea).

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, explained the initial experience gastroenterologists have had with anti–tumor necrosis factor biosimilars and how new adalimumab biosimilars will impact the space.

A collaborative exercise with 16 health care organizations nets millions in savings.

Here are the top 5 biosimilar articles for the week of October 2, 2023.

Pfizer’s Abrilada (adalimumab-afzb) became the second biosimilar referencing Humira (adalimumab) to receive an interchangeable designation. The new label is intended to expand patient access to biosimilars.

A recent webinar featured an in-depth discussion on the impacts that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.

Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.

September was graced with several regulatory updates from around the world, including some European and Japanese approvals, as well as the FDA’s 2-day workshop on the current science behind clinical efficacy testing for biosimilars and streamlining biosimilar development.

On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

Nuances in classification for insulin biosimilars can lead to frequent areas of confusion, according to 2 pharmacists.