Regulatory

Simlandi (AVT02) is the second high-concentration, citrate-free adalimumab (Humira) biosimilar to be approved in the Canada market.

In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.

Biobetters may gain an edge on reference products, and multiple biosimilars are under development for ophthalmic disorders, the authors write.

The companies hope to gain FDA approval for a high-concentration, citrate-free version of Hadlima, an adalimumab biosimilar that was approved in a lower concentration in July 2019.

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, explains pricing issues for reference drugs and biosimilars.

Biosimilars have produced more than $20 billion of savings in Europe, but more use of these agents is needed.

With an FDA approval for a second insulin glargine biosimilar, the stage is set for stronger competition in 2022 with potential improved access and savings for patients.

The Center for Biosimilars® spoke recently with Chad Landmon, chair of the Intellectual Property and Food and Drug Administration Practice Groups at Axinn, a New York–based antitrust, intellectual property, and litigation law firm.

Wayne Winegarden, PhD, discusses his savings analysis for adalimumab and etanercept biosimilars and their potential market share.

Lannett hopes to initiate a pivotal trial of its insulin glargine biosimilar candidate, in anticipation of a launch in 2024.

From the approval of the first insulin glargine biosimilar (Semglee) to the potential for extreme biosimilar competition in the adalimumab market, 2021's regulatory stories were popular with readers.

The year 2021 brought several firsts in biosimilars and set the stage for expansion across therapeutic areas including diabetes and ophthalmology.

Coherus BioSciences said the 40 mg subcutaneous formulation of adalimumab would be launched on or after July 1, 2023, in agreement with AbbVie, maker of Humira, the reference product.

A trio of regulatory experts discuss the current standing of biosimilar policy in the United States and expectations going forward.

An economist weighs in on whether interchangeable status will help adalimumab biosimilars succeed.

Alvotech has received European Commission (EC) approval to begin marketing its adalimumab biosimliar AVT02, the company announced this week.

Etanercept and adalimumab biosimilar competition is not only necessary to drive down prices, it’s long overdue, according to Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute.

In a review, Sandoz researchers discuss lingering barriers that prevent insulin prices from falling to more affordable levels.

Henlius gains approval in China for Hanbeitai and officials discuss combination therapy options with experimental therapy serplulimab and ophthalmology treatment.

Steven Yates, MD, an oncologist and medical director at Intermountain Healthcare, discusses problems underlying the 340B Drug Pricing Program.

Researchers report findings that suggest a different reimbursement system for Medicare Part B biologics could lead to significantly more robust savings.

In the second setback this year for etanercept biosimilars, the US District Court for the District of New Jersey has ordered Samsung Bioepis to delay marketing Eticovo until 2029.

Regulators are at work clarifying biosimilar guidance and on Capitol Hill, a battle is raging over reforms that could help or hurt biosimilar advancement.

Specialty tiers for biosimilars and reforms that address the proliferation of poor-quality patents would help lower costs and improve access, biosimilar industry veterans said.

An expert on biotherapeutics recommends more science be applied to World Health Organization (WHO) biosimilar guideline revisions.

Authors of a review discuss barriers to insulin access and potential solutions as the 100-year anniversary of the drug's first use for diabetes gets closer.

Progression-free survival (PFS) was improved for patients with epidermal growth factor receptor–mutated nonsquamous non–small cell lung cancer who were treated with PD-1 and antivascularization therapy.

The utilization rates for biosimilars in community oncology have been much higher than for other disease categories and are only expected to rise, says Steven Yates, MD.

European Medicines Agency (EMA) officials said their pilot was based on wrong assumptions about the biosimilar development process.

The World Health Organization (WHO) has issued a fresh draft of its biosimilar evaluation guidelines. Medicines for Europe science and policy expert Marta Baldrighi, PhD, explains the significance.