The Center for Biosimilars Staff

October 28, 2019

Drug maker Formycon announced today that it has begun a phase 1 clinical trial of its proposed ustekinumab biosimilar, FYB202, referencing Stelara. Ustekinumab is the first available therapy to target the interleukin-12 and -23 pathway.

October 26, 2019

As biosimilars for innovator biologics advance, drug makers are seeking new indications for products in their portfolios as a means to protect their sales against oncoming—or existing—competition. This month saw 3 notable label developments for drugs made by Janssen, Alexion, and AbbVie.

October 24, 2019

During the United European Gastroenterology Week 2019, held October 29-23 in Barcelona, Spain, researchers from Celltrion presented pooled data from 3 postmarketing studies of CT-P13 in patients with inflammatory bowel disease (IBD) that underscore the safety of the biosimilar.

October 23, 2019

The World Health Organization (WHO) and the International Generic and Biosimilar Medicines Association (IGBA), an umbrella organization with members including the Association for Accessible Medicines, Medicines for Europe, and a number of other national and regional generic and biosimilar organizations, have signed a memorandum of understanding.

October 19, 2019

Drug maker Pfenex announced this week that it has completed its comparative use human factors study for its follow-on teriparatide product, PF708, referencing the osteoporosis drug Forteo.

October 17, 2019

NeuClone said Thursday that it has begun dosing participants with its proposed ustekinumab biosimilar, referencing Stelara, in a phase 1 trial.

October 17, 2019

The Belgian Competition Authority, which contributes to implementing Belgium’s competition policy by addressing anticompetitive practices, announced that it is conducting inspections of some drug makers suspected of having implemented “restrictive practices aimed at limiting, delaying or even preventing the entry into the market or the expansion of biosimilar medicines competing with existing medicines."

October 15, 2019

The Japanese Adverse Drug Event Report (JADER) database, a large, published database managed by the Pharmaceuticals and Medical Devices Agency for pharmacovigilance, collects spontaneous reports as a means to detect adverse events (AEs) related to drugs, and a newly published study used the JADER data to assess AEs related to the reference infliximab and to the biosimilar, CT-P13.

October 14, 2019

While eculizumab is being targeted by multiple biosimilar developers who are in phase 3 clinical trials with their competitive products, spending on eculizumab is reaching concerning levels; as such, it is increasingly important to clarify eculizumab’s place in the treatment paradigm for myasthenia gravis (MG).

October 12, 2019

While biosimilar stakeholders’ eyes have been on the recent launch of new products and on policy proposals that stand to impact these therapies, several new proposed biosimilar agents are making their way into clinical trials.