Regulatory

In the third quarter, ending December 31, 2021, biosimilars revenues were up 28% year over year for Biocon Biologics Ltd.

Bret Jackson, president of the Economic Alliance for Michigan, notes that Ford Motor is a biosimilar success story, having saved a significant amount of money on just a handful of drugs.

Records show the biosimilar for bevacizumab was used to treat both new patients and those already receiving care with the reference product.

Insulin costs have increased dramatically in recent years, and the study authors note that high costs for many patients result in nonadherence or insulin rationing, leading to diabetic complications and even death.

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, shared his thoughts on which coverage type he expects will have the most robust biosimilar savings: Medicare, commercial, or military.

The International Generic and Biosimilar Medicines Association has appointed a veteran member, Vivian Frittelli, MBA, ACIS, to take over as chair.

Amgen Chairman and CEO Robert Bradway touted the potential of 11 biosimilars anticipated to be driving revenues for the company by 2030.

In a recent paper, Sarfaraz K. Niazi, PhD summarizes some of his central ideas on the relevance of FDA biosimilar testing standards.

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In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.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