Latest Conference Articles

Real-World Data Show Mixed Results for CT-P13 Worldwide

Kelly Davio

October 15 2018

During the American College of Rheumatology 2018 annual meeting, which will be held from October 19-24 in Chicago, Illinois, a variety of researchers will present on real-world data concerning biosimilar infliximab CT-P13.

In Europe, as in the US, Biosimilar Launch Prices Tell Only Part of the Story

Kelly Davio

September 28 2018

In the United States, biosimilar launches have been met with disappointment over what many view as too-shallow discounts to reference products’ list prices. However, as Aurelio Arias, a consultant at IQVIA, explained during the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, the substantial savings that the European market has realized with biosimilars are not necessarily reflected in list prices, either.

Fresenius Kabi Exec Weighs in on the Need for Clinical Trials of Biosimilars

Kelly Davio

September 28 2018

Recent weeks have seen heightened debate over the need for phase 3 confirmatory trials for biosimilars, with some stakeholders calling these trials unnecessary and others going so far as to call them unethical. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Uwe Gudat, MD, who serves as head of clinical safety and pharmacovigilance at Fresenius Kabi, weighed in. “The subject I raise is rather provocative,” he acknowledged.

WHO Reference Standards Will Serve as Biosimilar Benchmarks, Expert Says

Kelly Davio

September 27 2018

While every biologics manufacturer has its own standards against which it measures a product’s consistency over time, there is an increasing need for harmonization of these in-house standards with a public standard that can serve as a benchmark for the reference product and all biosimilars. This, explained Meenu Wadhwa, PhD, is where World Health Organization (WHO) international standards come in.

With Payers Under Pressure, Biosimilars Must Demonstrate Their Value

Kelly Davio

September 27 2018

In recent years, payers in Europe have been increasing their scrutiny of new therapies as increasingly high-cost drugs come to the market. And while the United States does not have the same cost constraints as the single-payer health systems, it too faces heightened pressures to lower costs in order to afford innovative therapies.

Switching to Biosimilars in the NHS Provides Savings, Presents Unique Challenges

Kelly Davio

September 26 2018

Fraser Cummings, MBChB, DPhil, led one of the first clinical teams to switch patients receiving the reference infliximab (Remicade) to CT-P13 (Remsima) in UK clinical practice. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Cummings explained his experience with this switch in his gastroenterology clinic, and looked ahead to the arrival of adalimumab biosimilars in the National Health Service (NHS).

Lessons From European Biosimilars: Where Have We Been, and Where Are We Going?

Kelly Davio

September 26 2018

In the early days of the market, explained Michael Muenzberg, MD, biosimilar developers had to decide between 2 business models, which he termed a “follow-on model” and a “biogeneric model.” The former involves investing in device design, safety data, and sales and marketing to compete on aspects other than price alone. The latter model, which has not emerged as a dominant option in Europe, is simply to make a product as cheap as possible.

Experts See Progress, Not Perfection, in the Biosimilar Reimbursement Landscape

Samantha DiGrande,Kelly Davio

September 9 2018

At a panel at the GRx+Biosims 2018, Molly Burich, MS, director of public policy for biosimilars and reimbursement at Boehringer Ingelheim, and Melissa Andel, MPP, vice president of health policy at Applied Policy, discussed the impact that US policy developments are having and will continue to have on the biosimilars market.

A Holistic Approach is Crucial for Biosimilar Uptake

Samantha DiGrande

September 8 2018

Alex Brill, CEO of Matrix Global Advisors, gave a presentation during the GRx+Biosims 2018 conference in Baltimore, Maryland that discussed the barriers to increased uptake of biosimilars in the United States, and how to address those issues.

FDA Has a Duty to Instill Confidence in Biosimilars, Experts Say

Samantha DiGrande,Kelly Davio

September 7 2018

In a session held at the GRx+Biosims 2018 conference in Baltimore, Maryland, Gillian Woollett, MD, DPhil, senior vice president of Avalere Health, and Michelle Lee-Bourner, head of regulatory affairs for biologics and respiratory products at Mylan, discussed experience with and expectations for biosimilar regulation.