Skylar Jeremias

The Center for Biosimilars® spoke recently with Chad Landmon, chair of the Intellectual Property and Food and Drug Administration Practice Groups at Axinn, a New York–based antitrust, intellectual property, and litigation law firm.

Wayne Winegarden, PhD, discusses his savings analysis for adalimumab and etanercept biosimilars and their potential market share.

An economist weighs in on whether interchangeable status will help adalimumab biosimilars succeed.

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

Etanercept and adalimumab biosimilar competition is not only necessary to drive down prices, it’s long overdue, according to Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute.

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

Karen van Caulil, PhD, president and CEO at Florida Alliance for Healthcare Value, discusses the difficulty her institution has had in getting providers and employers to switch to biosimilars.

Reimbursement concerns and the uncertainty of how interchangeability will impact biosimilar adoption are hot-button issues in the biosimilar space, Cate Lockhart, PharmD, PhD, MS, explains in this interview.

Oncology biosimilars are broadly in use for good reason: They're absolutely vital for cost reduction and access, but efforts are needed to promote uptake of these agents, says Gary Lyman, MD, MPH, in this interview.

Ivo Abraham, PhD, a professor with University of Arizona Health Sciences in the Department of Pharmacy Practice, outlines the current trajectory and savings potential for granulocyte-colony stimulating factor (G-CSF) biosimilars and Neulasta Onpro (pegfilgrastim).

Sonia T. Oskouei, PharmD, BCMAS, DPLA, the vice president of Biosimilars at Cardinal Health, discussed the many ways that pharmacists and interchangeability designations can affect biosimilar utilization.

Early study results indicate that STADA Arzneimittel and Xbrane Biopharma’s ranibizumab biosimilar is as safe and effective as the reference product, suggesting regulatory approval may be on the horizon.

Biosimilar companies partnered with other companies and saw earnings increases, while reference product corporations faced sales erosion from biosimilar competition.

To overcome provider and patient preferences for brand originators, there has to be more of an incentive to use biosimilars, explains Nedzad Pojskic, PhD, MSc, Green Shield Canada.

The month of March brought intense debate and legislative action over biosimilar policies.

EirGenix, in partnership with Sandoz, announced positive safety and efficacy results for its trastuzumab biosimilar in patients with breast cancer.

A panel of physicians gave advice on how biosimilar educational materials should instill confidence in these medications and which policies may be more harmful than beneficial.

Regulatory and launch news on rheumatology biosimilars for adalimumab and infliximab was plentiful in February 2021.

Findings from biosimilar studies of Kanjinti (trastuzumab) and Mvasi and Zirabev (bevacizumab) rounded out our oncology biosimilar coverage in January.

To spur more biosimilar development and reduce anticompetitive practices, the company argued the FDA could improve its interpretation of the term “strength” in the Biologics Price Competition and Innovation Act (BPCIA).

The FDA clarified a number of concerns surrounding the appropriate procedures for industry to apply for interchangeability status.

In November, the Supreme Court heard arguments on the Affordable Care Act, Europe fired up its efforts to create a more biosimilar-friendly environment, and Genentech fought to protect its bevacizumab franchise.

Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.

In Europe, the pandemic has revealed problems within health care systems and the need to increase access to biosimilars and reform health care policies.

Revance’s fight to compete in the onabotulinumtoxinA (Botox) market hit a snag when its drug candidate failed to meet the efficacy primary end point in a study.

Alvotech and Cipla have joined forces to bring biosimilars to treat oncology and autoimmune diseases to South Africa.

Prestige Biopharma and Teva Israel join forces to bring a trastuzumab biosimilar to the Israeli market.

Formycon and Bioeq say resubmission of the biologics license application for their ranibizumab candidate will not affect launch timing in US or European markets.

Alberta, Canada’s deadline for switching patients to biosimilars is months away, but the province has already seen some success with the new program.

Companies continued to prove in October that rare regulatory approvals and a pandemic have not stopped them from moving forward with plans to further products and search for ways to save money.