Tony Hagen

Henlius gains approval in China for Hanbeitai and officials discuss combination therapy options with experimental therapy serplulimab and ophthalmology treatment.

In the second setback this year for etanercept biosimilars, the US District Court for the District of New Jersey has ordered Samsung Bioepis to delay marketing Eticovo until 2029.

Specialty tiers for biosimilars and reforms that address the proliferation of poor-quality patents would help lower costs and improve access, biosimilar industry veterans said.

Authors of a new study estimated significant savings from biosimilars in Ontario based on deep price discounts and mandatory switching programs.

Progression-free survival (PFS) was improved for patients with epidermal growth factor receptor–mutated nonsquamous non–small cell lung cancer who were treated with PD-1 and antivascularization therapy.

Stakeholder education programs and robust data on clinical studies are key to building patient and provider support for biosimilars, according to a new whitepaper.

Martin Perry, MBChB, BSc, MMEd, FRCP, clinical medical director for the National Health Service in Greater Glasgow and Clyde, Scotland, explains frontline care with biosimilars during COVID-19.

Kathy Oubre, MS, a cochair of the biosimilars committee of the Community Oncology Alliance (COA), explains findings from a broad study of biosimilar use in oncology practices.

In its first quarter of independence from Pfizer, Organon saw growth in biosimilars revenue; Sandoz' biosimilar portfolio has been touted as a growth driver amid talk of a spinoff from Novartis.

Sarah Yim, MD, provided a point-by-point overview of the FDA's efforts to clarify the role of the interchangeable biosimilar designation, improve communication with manufacturers, and pay for biosimilar regulatory reviews.

Janet Woodcock, MD, acting commissioner of the FDA, said the agency is meeting with biosimilar developers for biosimilars for 46 reference products.

In its third quarter earnings report, Amgen addressed the give and take of biosimilar competition.

As House leaders sought to build support for the Build Back Better Act, the Association for Accessible Medicines (AAM) objected to drug price negotiations and proposed “rebate penalties.”

Prime Therapeutics said that by putting Semglee (insulin glargine) on formulary, along with other biosimilars, it could achieve savings of $41 million or more per year.

Kicking off Global Biosimilars Week, the International Generic and Biosimilar Medicines Association (IGBA) released a blueprint detailing hurdles and opportunities for industry progress.

Pfizer reports on biosimilar revenues and says its switching studies for Abrilada, an adalimumab biosimilar, support interchangeable status.

The second interchangeable biosimilar approval, estimates of biosimilar savings, and competition for ranibizumab biosimilars characterized the month's developments.

Payers have moved from toe-in-the-water biosimilar policies to aggressive management, contributing to much more robust savings in recent years, according to Leslie Fish, RPh, PharmD, vice president of pharmacy at IPD Analytics.

The arrival of Susvimo, an ocular implant for treatment of macular degeneration, poses a challenge for ophthalmic reference products and biosimilars.

Competitors in the field of adalimumab and insulin products may soon include “authorized biologics” in addition to biosimilars and interchangeable biosimilars, a pharmacy expert explains at the Academy of Managed Care Pharmacy Nexus 2021 meeting.

The company said growth into new biosimilar markets fueled revenue growth during the quarter just ended. It is also working to correct factory problems identified in a September FDA inspection.

Patients with and without experience with tumor necrosis factor (TNF)–blocker biologics have incomplete knowledge of biosimilars for these agents, according to findings presented at the Academy of Managed Care Pharmacy 2021 Nexus meeting.

Pharmacists need to brush up on their knowledge of the interchangeable biosimilar designation, investigators said in a survey presentation at the Academy of Managed Care Pharmacy Nexus 2021 meeting.

Hopes that insulin biosimilars can improve access and affordability will be tested by Express Scripts’ plan to give preferred formulary status to Semglee, a long-acting insulin that is interchangeable with Lantus.

Over a 10-year period, Basaglar, considered an unofficial biosimilar, achieved price drops in the insulin glargine market and took a significant market share from Lantus.

The report from CoverMyMeds, a division of McKesson, discusses payer/pharmacy benefit manager consolidation, patient adherence, white bagging, and other issues common to specialty pharma.

The interchangeable designation allows pharmacists more flexibility to dispense this potentially money-saving product and gives Boehringer Ingelheim a marketing edge.

Investigators said the RAAS study filled in missing information on the value of dose modulations and infusion interval changes for patients with ankylosing spondylitis (AS) treated with CT-P13 (Remsima, Inflectra).

An interactive tool from Biosimilars Forum, an industry group, uses data from Pacific Research Institute to calculate potential biosimilar savings based on 75% market share.

The European Commission is collecting comment on its multifaceted blueprint for broadening access to biologics and generic drugs and stimulating competition.