Biosimilar switching: new evidence against interchangeability

Biosimilar Switching Not Suitable For All Patients 100% of patients?who developed antibodies to?innovator anti-TNF-? exhibited antibody reactivity against the biosimilar. ?Study results cast?doubt on interchangeability. 8 June 2016 According to a report from European League Against Rheumatism Annual Congress (EULAR) 2016, patients with antibodies to biological infliximab are less likely to benefit from infliximab biosimilar[…]

Biosimilar nomenclature: Deadline August 2 for comments on FDA’s OMB information request

Meaningful suffix may be in for U.S. biologics, biosimilars     FDA Pushes Back Comment Period for Biosimilar Labeling Just released: new deadline August?2 for information collection request it submitted to the White House Office of Management and Budget (OMB)     Additional Reading FDA approves Inflectra, a biosimilar to Remicade A Rocky Start for[…]

Pipeline biosimilar for asthma meets primary endpoint in P2/3 study

In Brief Biosimilar News reports that Sorrento’s experimental anti-IgE biosimilar, STI-004, met it’s primary endpoint in a 32-week, Phase 2/3 study conducted in China. ?Patients who received?STI-004 experienced?asthma exacerbation at a lower rate than those who received placebo: ?21% vs?55%. According to the Sorrento press release, the patient population included both?adult and adolescents suffering from[…]