News

A panel of experts details the current concerns regarding interchangeability designations for biosimilars in the United States and calls for regulators and policy makers to make changes to allow to easier access to biosimilars and greater adoption.

Selexis and Generium launched an omalizumab biosimilar on the Russian market; Remsima sales hit a record high for Celltrion Healthcare; Xbrane Biopharma shares long-term results for its ranibizumab biosimilar.

In a 50-46 vote, the Senate confirmed Robert Califf, MD, as President Biden’s FDA commissioner. The agency has been without a permanent leader for more than a year.

Iceland’s national health plan required patients to switch from Humira to the Samsung Bioepis biosimilar, Imraldi, which had a different injection device and contained citrate, a chemical buffer used to maintain the medication’s stability.

The year 2021 proved to be big for biosimilars, with 4 approvals and increased competition, signaling that FDA is shifting some of their focus from the pandemic back to the growing industry.

The study had no explanations for why patients stopped taking biosimilars or switched back to the reference product; authors said this merits further research.

Here are the top 5 biosimilar articles for the week of February 7, 2022.

Biogen and Xbrane Biopharma signed a commercialization agreement for Xcimzane, a certolizumab pegol biosimilar referencing Cimzia for the treatment of rheumatoid arthritis, psoriasis, and other rheumatologic conditions.

Health Canada approved biosimilars Brenzys and Erelzi in August 2016 and April 2017, respectively. The study tracked effects of the first phase of the British Columbia Ministry of Health’s Biosimilar Initiative, which required patients to switch to biosimilars starting in May 2019.

The year 2022 “is set to be a turning point” in the United States, as biosimilars are on their way to delivering $133 billion in aggregate savings by 2025, according to Cardinal Health's “2022 Biosimilars Report: The U.S. Journey and Path Ahead.”

The IGBA maintains dialogue with other national, regional, and international bodies to ensure patient access to high-quality, safe, and effective medicines while reducing costs in pharmaceutical care.

Julie M. Reed, the new executive director of the Biosimilars Forum, gives a timeline of her career in the biosimilars space and what led her to be one of the founders of the organization.

The province is the latest jurisdiction to adopt a program that will require patients to switch away from expensive reference biologics to select biosimilars for certain conditions.

Here are the top 5 biosimilar articles for the week of January 31, 2022.

Health Canada approves Ontruzant, the fifth Samsung Bioepis biosimilar to be approved for the Canadian market.

The non-profit organization dedicated to the advancement of biosimilars has appointed Cofounder and President Juliana (Julie) M. Reed, as the new executive director. Reed shared some of her goals for the Biosimilars Forum in an interview with The Center for Biosimilars®.

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, discusses how to ensure affordability of adalimumab biosimilars when they enter the market as AbbVie continues to raise the price of the reference product (Humira).

In a deal to sell the 50% ownership stake, Biogen would receive up to $2.3 billion.

Here are the top 5 biosimilar articles for the week of January 24, 2022.

Two new studies have investigated the adalimumab biosimilar SB5 (Imraldi; Samsung Bioepis) in inflammatory bowel disease (IBD; Crohn’s disease and ulcerative colitis) and non-anterior uveitis associated with Behcet's syndrome (BS).

US biosimilar uptake faces several barriers, including misconceptions regarding biosimilar efficacy and a misalignment of prescription incentives between payers, providers, and patients, panelists discussed.

Many governments have aligned their guidelines with those published by the World Health Organization (WHO) and the European Medicines Agency (EMA).

Sean McGowan, senior director of Biosimilars for AmerisourceBergen, forecasts potential biosimilar approvals and launches in 2022 as well as offers insights into how emerging biosimilars will impact the market and pricing in the coming years during an interview.

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, talks about what kind of educational material still needs to be created and which stakeholders are in need of education on the financial benefits of biosimilars.

Here are the top 5 biosimilar articles for the week of January 17, 2022.

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

Two biosimilars, Pfizer’s Zirabev and Amgen’s Mvasi, have been approved for indications including unresectable, locally advanced NSCLC and recurrent or metastatic nonsquamous NSCLC. BI 695502 is no longer under development by Boehringer Ingelheim.

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.