News

Since the start of 2022, China’s National Medicinal Products Administration (NMPA) has made strides to increase access to biosimilar products for various rheumatic conditions, including 3 biosimilar approvals and 1 biosimilar receiving an expanded indication.

Kathy Oubre, MS, chief executive officer of Pontchartrain Cancer Center, explains the progress she has seen regarding biosimilar utilization and acceptance.

As HHS prepares to begin a study that will summarize the use and spending of biosimilars within Medicare Part B plans, the FDA updates its clinical trial guidance to expand enrollment access to senior patients.

Here are the top 5 biosimilar articles for the week of March 14, 2022.

Gillian Woollett, MA, Dphil, vice president and head of regulatory strategy and policy at Samsung Bioepis, reviews some of the presentations, including her own, from the Festival of Biologics conference.

OcyonBio signed a Good Manufacturing Practice (GMP) agreement for the manufacturing of biosimilars in Puerto Rico, while Evio Pharmacy Solutions implemented a strategy aimed at increasing biosimilar affordability.

Pfizer’s trastuzumab biosimilar (trastuzumab-qyyp; Trazimera) was stable and efficacious under conditions of extended use in patients with breast cancer, investigators concluded.

A phase 1 study testing Celltrion Healthcare’s omalizumab biosimilar in healthy subjects showed similar safety and pharmacokinetic profiles to the reference product (Xolair), as presented at the American Academy of Allergy Asthma and Immunology’s annual meeting.

Julie M. Reed, the new executive director of the Biosimilars Forum, shares how the Forum is preparing for the US market introduction of the first FDA-approved adalimumab biosimilars.

The Committee for Medicinal Products for Human Use (CHMP) recommended 2 insulin biosimilars for marketing authorization in Europe.

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

Canada’s regulatory agency approved Samsung Bioepis’ Byooviz as the first ranibizumab biosimilar for the Canadian market for the treatment of ophthalmic conditions.

At a session at the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, panelists suggested that the quest for rebates by pharmacy benefit managers (PBMs) prevents uptake on some biosimilars—and could soon bleed over into biosimilar formulary placement.

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.

Teva’s launch makes it the first competitor to Revlimid in the United States, but perhaps not the last.

Civica Rx will collaborate with companies to manufacture and distribute 3 insulin biosimilars and will offer them at an affordable price to uninsured and underinsured patients.

Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer Center, explains how biosimilars are helping to rid clinicians of their worries about the affordability of biologic drugs.

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

Here are the top 5 biosimilar articles for the week of February 28, 2022.

Releuko, a filgrastim biosimilar developed by Kashiv Biosciences and Amneal Pharmaceuticals, has received FDA approval, the first of 2022.

February kicked off with a number of regulatory updates from around the world, including the FDA acceptance of applications for interchangeable adalimumab biosimilars, Health Canada’s approval of Ontruzant, and more.

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

The FDA has accepted biologics license applications (BLAs) for interchangeability status from Alvotech and Pfizer regarding their respective adalimumab biosimilars referencing Humira.

Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer Center, previews her upcoming presentations at the Festival of Biologics conference.

Switching patients with Crohn disease from reference adalimumab to SB5, a Samsung Bioepis biosimilar, did not lead to major changes in disease activity in a real-world analysis.

Here are the top 5 biosimilar articles for the week of February 21, 2022.

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.

There remains risk in the US market due to regulatory and legal hurdles—not to mention a combative political environment, according to executives who gathered last week during the “CEOs Unplugged” session at Access! 2022, held by the Association for Accessible Medicines (AAM) in Orlando.

Tuznue, which references Roche’s Herceptin, is currently under review for marketing authorization by the EU European Medicines Agency, Canada, and South Korea.

A report from AHIP found 3 drugs that have multiple biosimilars available can be delivered more affordably through specialty pharmacies.