News

No statistically significant risk in terms of lack of effectiveness or safety was found for patients who switched therapies versus those who remained on their first therapy in either the reference group or the biosimilar group.
China-based drug maker Henlius has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for a trastuzumab biosimilar, HLX02, referencing Herceptin.
Drug maker Alexion, developer of the rare disease drug eculizumab (Soliris), announced Friday that the FDA has accepted for priority review its long-acting C5 complement inhibitor, ravulizumab (Ultomiris), which offers less frequent administration than eculizumab. 
Slow uptake of biosimilars, among other factors, will help propel drug spending over the next 7 years, according to a report released this week by PwC’s Health Research Institute (HRI).
 
The attributes for the N-glycan profile, FcγRIIIa binding activity, and relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity for the reference trastuzumab resulted in reduced ADCC and FcγRIIIa binding activities.  
The Center for Biosimilars® recaps the top stories for the week of June 17, 2019.
During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, researchers presented their interim safety results from the REFLECT study, a prospective, noninterventional, observational, multicenter, open-label study of the biosimilar rituximab Rixathon as a curative therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with previously untreated CD20-positive diffuse large B-cell lymphoma.
Legislators on Capitol Hill are moving forward this month with bills that address patent issues pertaining to biosimilars.
 
According to the authors of a new study, while biologics are often believed to be more time consuming to develop than small-molecule drugs, development times are, in fact, similar between these 2 drug types.
A worldwide survey conducted by an international type 1 diabetes (T1D) advocacy non-profit found that rationing of insulin and related supplies was the greatest in the Unites States.
 

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