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As the United States lags behind Europe and other highly regulated areas in terms of biosimilar approval and uptake, research presented during the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting in Baltimore, Maryland, points to slow market entry and small price discounts of approved biosimilar products as key factors that are holding up cost savings in the US market.

At the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting, in Baltimore, Maryland, members of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) discussed the ways in which their organization, a not-for-profit entity that conducts postmarketing observational research to monitor biosimilars and novel biologics for efficacy and safety, is working to provide real-world evidence on these products to stakeholders.

On Tuesday and Wednesday, during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Maryland, researchers from Europe addressed the fact that, while biosimilars have a longer history in the European marketplace than they have in the United States, challenges to uptake still linger.

In a Monday workshop held at the International Society for Pharmacoeconomics and Outcomes Research’s 23rd Annual International Meeting, in Baltimore, Maryland, Mike Blum, MD, MPH, deputy director in the Office of Pharmacovigilance and Epidemiology at FDA, addressed the role of postmarketing surveillance in the US biosimilars market and the potential role of real-world evidence in interchangeable designations for biosimilars.

Today, at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting, held in Baltimore, Maryland, researchers addressed the complexities of using anti–tumor necrosis factor (anti-TNF) therapy in patients with rheumatoid arthritis (RA).

In a panel during the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, rheumatologist Madelaine Feldman, MD; Wayne Winegarden, PhD, of the Pacific Research Institute; and rheumatologist Angus Worthing, MD, chair of the American College of Rheumatology’s Government Affairs Committee, discussed trends in healthcare payment models.

At the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, Earl “Buddy” Carter, Republican Congressman for Georgia’s first legislative district, highlighted his work to control the price of drugs for patients.

A panel of health experts discussed the pathway and speed of biosimilar development, as well as the barriers to major uptake of these drugs, during a discussion at the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17.

Over time, the United States will see a dramatic increase in the number of biosimilar approvals based on the quantity of applications that the FDA is currently receiving, said Leah Christl, PhD, associate director for therapeutic biologics at the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, at the National Policy and Advocacy Summit on Biologics and Biosimilars held in Washington, DC, on April 17.

During a panel session at the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, panelists discussed key barriers to accessing biologics and other innovative treatments, as well as how patient advocacy can be leveraged to chip away at those barriers.

A recent study found that Cinfa Biotech’s proposed pegfilgrastim biosimilar, B12019, has similar pharmacodynamics (PD) and immunogenicity to the reference Neulasta.

Patients can be switched from reference rituximab (MabThera) to biosimilar rituximab (Truxima) without reverting to slower infusion rates, according to a new study.

A new study, conducted by Linglong Zou, PhD, and colleagues, evaluates the immunogenicity of tbo-filgrastim in patients receiving chemotherapy for solid and hematologic malignancies.

At the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Sanjeeev Balu, PhD, will present results of a study that examines expanded access to the drug obinutuzumab (Gazyva) made possible on a budget-neutral basis through savings obtained from using biosimilar filgrastim-sndz (Zarxio).

Since Novex’s commercial launch, the first national pharmacovigilance plan for a biosimilar monoclonal antibody has been implemented, and data from this post-marketing surveillance show that, in terms of tolerability, this biosimilar has a similar safety profile to that of the reference product.

On Sunday, December 10, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Noah Federman, MD, will present research from a phase 2 study on the use of subcutaneous tbo-filgrastim (Granix) in pediatric patients with solid tumors who are undergoing chemotherapy.

On Saturday, December 9, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Scott Huntington, MD, MPH, will present his research team’s findings that the receipt of lymphoma care in the community-based setting is associated with guideline-discordant use of rituximab.

In a Thursday session of the SMi Biosimilars North America 2017 conference, Cindy Cao, PhD, executive director and head of United States regulatory affairs at Sandoz, looked ahead to the advent of interchangeable biosimilars.

Mkaya Mwamburi, MD, PhD, MA, president and CEO of the biotechnology consulting firm profecyINTEL, said in a presentation at the 2017 SMi Biosimilar North America conference that manufacturers of originator biologics are taking the lead on biosimilar development.

In a Wednesday session of the SMi Biosimilars North America 2017 conference, Gary Cupit, PharmD, senior advisor to the investment bank Frontcourt Group, gave biosimilar manufacturers his perspective on the market access challenges facing biosimilar developers.

Steinar Madsen, MD, medical director of the Norwegian Medicines Agency, shared lessons learned from the Norwegian experience with biosimilars in a Wednesday talk at the SMi Biosimilars North America conference.

At a Wednesday session of the SMi Biosimilars North America conference, Chrys Kokino, MBA, head of Mylan’s global biologics commercial division, said that biosimilars can be part of improving access to and affordability of biologic therapies for patients worldwide, but also highlighted the hurdles that biosimilar developers will have to overcome as they seek to gain a foothold in the US marketplace.

Three presentations at the 2017 American College of Rheumatology’s Annual Meeting in San Diego, California, covered research on the real-world treatment of rheumatology patients with originator infliximab therapy and biosimilar infliximab (CT-P13; Inflectra and Remsima) and etanercept (Benepali) therapy.

“If the patient doesn’t have better access, you don’t need a biosimilar," argues Roy Fleischmann, MD.

Chinese researchers employed a new online consultation tool to improve disease management for patients with rheumatic diseases who travel long distances for a consultation with their rheumatologist and noted significant savings for the patients.

Four presentations on Monday at the 2017 American College of Rheumatology’s (ACR) Annual Meeting in San Diego, California, covered research comparing reference etanercept to 4 proposed biosimilars: SB4, LBEC0101, CHS-0214, and GP2015.

At this week’s American College of Rheumatology 2017 Annual Meeting, Boehringer Ingelheim (BI) announced 1-year data from the VOLTAIRE-RA trial, which showed that BI’s newly approved adalimumab biosimilar (Cyltezo) showed no clinically meaningful differences in safety, efficacy, or immunogenicity from the reference adalimumab (Humira) in patients who had moderate to severe rheumatoid arthritis (RA).

On Tuesday, 2 research groups presented findings from studies conducted in patients with rheumatoid arthritis (RA) who were switched from reference rituximab to a biosimilar therapy.

Research presented at the 2017 American College of Rheumatology Annual Meeting found that patients with rheumatoid arthritis and higher body mass index were less likely to achieve remission and more likely to face higher rates of disability.

Today, 4 presentations at the 2017 American College of Rheumatology’s (ACR) Annual Meeting in San Diego, California, covered research on switching studies concerning etanercept and infliximab biosimilars.