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Investigators said TX05 met pathologic complete response criteria for equivalence to the originator product, Herceptin. The biosimilar candidate also fell within objective response rate, immunogenicity, safety, and tolerability margins for similarity.

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, discusses some of the tactics that biosimilar companies are employing in order to level the playing field and better compete against originator companies.

According to a multiyear, retrospective study, filgrastim biosimilar Zarxio cost $20.50 more on average per administration than reference Neupogen in the hospital outpatient setting.

Alvotech gains an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; BioFactura looks to deliver ustekinumab via a robotic pill.

BCD-021 demonstrated equivalence in a phase 3 study involving Russian and Indian patients with advanced non–small cell lung cancer (NSCLC).

Here are the top 5 biosimilar articles for the week of September 13, 2021.

MIL60 bevacizumab biosimilar candidate demonstrates equivalence to the originator Avastin in a population of Chinese patients with non–small cell lung cancer (NSCLC) treated in a frontline setting.

The “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA) is meant to resolve litigation efficiently, and it does, although in practice biosimilar developers and originator companies may not completely adhere to the prescribed steps, according to Biotechnology Innovation Organization (BIO) experts.

The positive findings for the trastuzumab biosimilar Ontruzant in patients with human epidermal growth factor receptor 2 (HER2)–positive early or locally advanced breast cancer were presented at the European Society for Medical Oncology (ESMO) Congress 2021.

The Alliance for Safe Biologic Medicines (ASBM) has fought since 2010 in opposition of payer policies that promote automatic switching to cheaper biologics including biosimilars. The group's new chair is no newcomer to this battle.

Companies that gain Drug Controller General of India (DCGI) marketing authorization are likely in for much more extensive trials if they hope to commercialize their biosimilars on the global platform.

Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer what the author considers a more "rational approach."

Here are the top 5 biosimilar articles for the week of September 6, 2021.

The findings support Alvotech's bid for interchangeable status for the high-concentration, citrate-free adalimumab biosimilar candidate.

The strength of a patent wall built up around an originator biologic depends on the quality of patents that make it up and the originator company's willingness to engage in costly litigation. Part 2 of a series.

In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.

Shanghai Henlius Biotech, Innovent Biologics, and other Chinese biopharmaceutical makers are leading the wave of Asia-Pacific (APAC) biosimilar development, according to a GlobalData analyst.

Kaiser Permanente got biosimilars into circulation by building physician confidence, a strategy that a Samsung Bioepis executive says should be employed more widely.

Gary Lyman, MD, MPH, an oncologist and hematologist, explains that biosimilar substitution in the absence of interchangeability designations is widespread and not without clinical merit.

Animal toxicology studies still get included with biosimilar approval applications, although there are strong arguments that most of these studies are unnecessary. Sarfaraz K. Niazi, PhD, explains the pros and cons.

Here are the top 5 biosimilar articles for the week of August 30, 2021.

A meta-analysis of pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of Sandoz pegfilgrastim biosimilar confirms biosimilarity.

Catherine Swick, MBA, senior vice president of Provider Strategy and Marketing at McKesson, discusses efforts to get oncology biosimilars into play at US Oncology Network.

Policy developments, business milestones, and physician-led efforts to shape biosimilar absorption made August 2021 an active time for these lower-cost biologics.

Misperceptions of biosimilars contribute to low acceptance of these products. Two Cardinal Health researchers discuss barriers to understanding and the importance of biosimilar education.

Byooviz, developed by Samsung Bioepis, will be distributed by Biogen in the European Union, where it becomes the first ranibizumab biosimilar. An application is under review with the FDA.

Clinical efficacy studies are not always required for biosimilars, and it's possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a game plan.

Bio-Thera Solutions has found a partner to help with US distribution of its proposed ustekinumab biosimilar, which entered phase 3 trial development this summer.

Here are the top 5 biosimilar articles for the week of August 23, 2021.

Cipla, a medicines developer and retailer, and Kemwell Biopharma, a contract manufacturer, intend to produce biosimilars for lung disorders.