The Center for Biosimilars Staff

June 19, 2018

During the fourth congress of the European Academy of Neurology, held in Lisbon, Portugal, from June 16 to 19, researchers reported on CinnaGen’s biosimilar interferon beta 1A drug, CinnoVex, in treating multiple sclerosis (MS).

June 12, 2018

If European League Against Rheumatism guidelines are followed, when a patient with rheumatoid arthritis (RA) does not reach remission or a state of low disease activity after 6 months of treatment, then the patient’s treatment should be modified regardless of the drug therapy being used (biologic or small molecule).

June 10, 2018

The American Society of Clinical Oncology’s (ASCO) annual meeting, held June 1-5, 2018, in Chicago, Illinois, featured results of numerous studies on biosimilars in anticancer and supportive care. Here are 5 key takeaways from the meeting.

June 06, 2018

Republic of Korea-based biosimilar developer Celltrion, maker of Inflectra, has announced that it will launch a contract development and manufacturing business to develop novel agents alongside its biosimilar pipeline.

May 30, 2018

Biosimilar developer Celltrion has resubmitted its Biologics License Application (BLA) for a proposed rituximab biosimilar, CT-P10, to the FDA for regulatory consideration. The company received a Complete Response Letter for the drug in April 2018, after having received an earlier warning letter from the agency that raised concerns about the company’s manufacturing processes.

May 29, 2018

While it is already known that obesity may contribute to an increased risk developing some immune-mediated inflammatory diseases, as well as more severe disease activity and a higher burden of hospitalization, a new review found that obesity is also a predictor of inferior response to anti–tumor necrosis factor (anti-TNF) agents.

May 28, 2018

The authors of a recent study report that the addition of a disease-modifying anti-rheumatic drug (DMARD) or a switch to ustekinumab showed greater efficacy than changing anti–tumor necrosis factor (anti-TNF) treatments in patients with inflammatory bowel disease (IBD) who develop paradoxical arthritis.

May 27, 2018

At the International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR) 23rd Annual International Meeting in Baltimore, Maryland, researchers and speakers highlighted emerging trends in biosimilars. Here are 7 key takeaways from the conference.

May 13, 2018

In treating ankylosing spondylitis, anti–tumor necrosis factor (anti-TNF) drugs produce a response in approximately 60% of patients. For the 40% of patients who do not respond to treatment, previous studies have suggested that patient characteristics, including sex, may play a role.

May 10, 2018

Today, Australian drug developer NeuClone announced positive preclinical results of its proposed ustekinumab biosimilar referencing Stelara. Ustekinumab is a monoclonal antibody that targets interleukin-12 and -23, and the reference product is approved to treat plaque psoriasis, psoriatic arthritis, and Crohn disease.