Business

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.

Improving access and getting big legislative changes for biosimilars passed are just some of the many plans that Julie M. Reed, the new executive director of the Biosimilars Forum, has for the organization.

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

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®.

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.

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.

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.

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.

As chief science policy officer for Global Healthy Living Foundation, Robert Popovian, PharmD, MS, has a bird’s-eye view of some of the central issues of biosimilar access in the United States.

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.

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

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

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.

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

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

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.

Ali Ahmed, senior vice president of biosimilars for Fresenius Kabi USA discusses FDA review of the company’s Stimufend pegfilgrastim biosimilar candidate and the marketing of this product.

Reimbursement concerns and the uncertainty of how interchangeability will impact biosimilar adoption are hot-button issues in the biosimilar space, Cate Lockhart, PharmD, PhD, MS, explains in this interview.

In this interview with The Center for Biosimilars®, Amgen biosimilars expert Jen Norton discusses regulatory and policy incentives, interchangeable biosimilars, and market share gains.