Development

AbbVie settles outstanding lawsuits, including its case related to the International Trade Commission (ITC), with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval.

Shanghai Henlius Biotech announced a commercialization agreement with Getz Pharma Limited for an adalimumab biosimilar for various African and Asian countries.

Under a new agreement, Biocon Biologics will take over Viatris’ biosimilar business, according to statements made by the companies.

A report from the National Alliance of Healthcare Purchaser Coalitions detailed the common concerns employers have regarding implementing biosimilars within their health care plans and outlined how they could take charge and make a difference.

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.

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.

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.

Xolair, the only currently approved product containing omalizumab, was first approved in 2003. AVT23 is an investigational compound and has not received regulatory approval in any country. Current sales of Xolair are estimated at $3.3 billion.

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®.

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).

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

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.

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

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.

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.

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, discusses his predictions for etanercept and adalimumab biosimilar pricing and why he hopes manufacturers will offer them at large discounts to reference biologics.

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.

A comparative study of PanGen Biotech’s epoetin alfa biosimilar candidate PDA10 and the reference product, Retacrit, demonstrated comparable efficacy and safety.

Patients with stage IV nonsquamous non–small cell lung cancer (NSCLC) demonstrated equivalent outcomes when treated with MYL-1402O or Avastin.

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

The top legal stories in biosimilars over the past year concerned etanercept and adalimumab biosimilars and access to insulin.

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.

With fewer of the risks associated with novel drug development, biosimilar candidates allow manufacturers to plan far into the future for marketing needs.

Business stories about Celltrion, the potential for mRNA biosimilar vaccines, and Amgen's biosimilars overview topped the rankings for reader popularity in 2021.

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

After an unsuccessful attempt to get an Illinois court to block the distribution of Alvotech's adalimumab candidate, AbbVie has tried again in a new forum.