Skylar Jeremias

During the month of March, rheumatology biosimilars have received a lot of praise in a regulatory, business, and legal sense, especially regarding the landmark settlement between Alvotech and AbbVie over an adalimumab biosimilar.

Gillian Woollett, MA, Dphil, vice president and head of regulatory strategy and policy at Samsung Bioepis, explains why there's no easy to solution to getting the US biosimilar market to the same level as Europe.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, previews his sessions about the new and emerging pharmaceutical products coming down the pipeline at the upcoming Academy of Managed Care Pharmacy (AMCP) annual meeting.

Alvotech and Fuji Pharma signed a deal for a biosimilar in Japan; Signet partnered with Juno Pharmaceuticals to grow equity investment; and Sandoz expanded its ability to produce generic respiratory drugs by acquiring Coalesce.

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

Three biosimilars used for blood clot prevention secure public reimbursement status in British Columbia, one of several Canadian provinces that has a biosimilar switching program.

An international phase 3 study of patients with erb-B2 receptor tyrosine kinase 2-positive (ERBB2+) breast cancer showed that Tuznue, a trastuzumab biosimilar, had comparable safety and efficacy to the reference product (Herceptin).

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.

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.

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.

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.