News

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.

CVS Caremark has reordered its list of preferred therapeutics, adjusting the emphasis on biosimilars, and demonstrating that preferential status can change at any time.

The International Psoriasis Council (IPC) reaches consensus on switching, patient agreement, and biosimilar safety and efficacy qualification. The IPC guidance is conservative when it comes to substitution of these products.

How many switches between a biosimilar and reference product will be sufficient to demonstrate that the risk of transitioning is minimal? A virtual study verifies the strength of FDA guidance.

A multicenter study of recombinant human growth hormone (rhGH) in children with Turner syndrome demonstrated safety and efficacy comparable to the reference product.

Gary Lyman, MD, MPH, an oncologist and hematologist, discusses how biosimilar placement on formularies affects physicians' willingness to prescribe these agents.

Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggests that using the 351(a) pathway for standalone drugs and copy products may be faster and better. This is part 3 of a series.

A group of 16 advocacy groups are urging HHS to make zero co-pays for biologics a part of its prescription drug price reform program.

Here are the top 5 biosimilar articles for the week of August 16, 2021.

UnitedHealthcare (UHC) backs away from its biosimilar inclusion policy after the American Academy of Ophthalmology (AAO) raises concerns about safety and lack of clinical evidence.

Centus Biotherapeutics reports positive findings from AVANA for its bevacizumab biosimilar candidate.

Chad Pettit, MBA, executive director of Marketing and the Global Biosimilars commercial lead for Amgen, discussed the company’s 2021 Biosimilar Trends Report and his projections for the future of the biosimilars market.

After the loss of a manufacturing plant in China and a knock-down-drag-out battle with Johnson & Johnson, is Pfizer cooling on biosimilars?

A retrospective study of rituximab biosimilars Truxima and Riximyo demonstrated comparable response and survival for patients with diffuse large B-cell lymphoma (DLBCL).

Gary Lyman, MD, MPH, an oncologist and hematologist, discusses some of the issues holding physicians back from prescribing biosimilars and some ways to ensure provider confidence in biosimilars.