News

Chelsee Jensen, PharmD, and Eric Tichy, PharmD, MBA, who coauthored a paper on the Mayo Clinic's success with implementing biosimilars, discuss their study and how their practice is expected to evolve to improve its approach.

The executive director of the Biosimilars Forum calls for policies to support adoption of lower-cost biologics.

During a session at the Academy of Managed Care Pharmacy annual meeting, Yuqian Liu, PharmD, of Magellan Rx Management, highlighted strategies to encourage biosimilar utilization in the oncology space and the cost savings as a result.

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

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.

An article reviewed the totality of evidence leading to the approval of Amgen’s infliximab biosimilar ABP 710 (Avsola), which is currently approved in the US and Canada for all the indications of the originator (Remicade).

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.

A series of initiatives to improve uptake of the biosimilars for 7 originator biologics resulted in significant savings for Providence St. Joseph Health.

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).

A patient with ankylosing spondylitis (AS) and ulcerative colitis (UC) was diagnosed with polychondritis after taking an infliximab biosimilar, suggesting that patients with similar circumstances should be carefully monitored.

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.