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.

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).

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.

September 25, 2018

Notably, the study was conducted in patients with cancer, rather than in a healthy population, to generate evidence of pharmacokinetic (PK) equivalence in a scenario that reflects how the biosimilar would be used in clinical practice.

September 25, 2018

The latest review seeking to reassure clinicians about the safety of switching their patients to biosimilars focuses on rheumatology indications.

September 24, 2018

A United Kingdom court has ruled in favor of the National Health Service, allowing the health system to provide intravitreal injections of the anti–vascular endothelial growth factor agent bevacizumab to patients with age-related macular degeneration (AMD).

September 21, 2018

Today, Sandoz, Cinfa Biotech, and Mylan all revealed that they have received positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for proposed pegfilgrastim biosimilars referencing Neulasta.

September 20, 2018

Treating ankylosing spondylitis (AS) is costly, even in high-income nations. In lower-income countries, patients may face serious challenges in accessing high-cost drugs, like anti–tumor necrosis factor agents, even when biosimilars are available.

September 20, 2018

The partnership says that it will launch the drug in the European Union on or after October 16, 2018.

September 19, 2018

During the 20th Asia Pacific League of Associations for Rheumatology (APLAR) Congress, held September 6 to 9 in Kaohsiung, Taiwan, researchers presented on real-world experience with switching to biosimilars in treating rheumatic diseases.