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Recent articles about biosimilars hold readers’ interest
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While no biosimilars indicated for rheumatic diseases in the U.S. have been approved by the FDA, reader interest in the topic has been high as results from clinical trials and other clinical data are revealed.
Recently, the FDA issued draft guidance regarding the nonproprietary naming system it intends to use for new biologic agents in the future, and the agency also announced new names for several existing products. No dates have been announced in respect to hearings about biosimilar applications that have been submitted to the FDA. Some have been approved in Canada, Europe and elsewhere, and readers at Healio.com/Rheumatology have expressed an interest in the topic by visiting the following pages.
Immunogenicity to Remicade, biosimilar similar in patients with RA, AS
Patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) responded with a similar immunogenicity profile to Remicade and the Remicade biosimilar, Remsima, but other differences were observed between the two patient groups, according to recently presented research. Read more.
Safety profile of Remsima biosimilar appears to be similar to Remicade in patients with RA, AS
A safety profile consistent with that of the historical safety data of Remicade was observed among patients with RA and AS treated with the Remicade biosimilar, Remsima, according to analysis results. Read more.
Samsung Bioepis’ Humira biosimilar meets primary endpoints in phase 3 RA trial
Samsung Bioepis has announced that its biosimilar to Humira has met its primary endpoint in a phase 3 trial by demonstrating equivalence to the original in the treatment of moderate-to-severe RA, according to a company press release. Read more.
Biosimilars Forum praises representatives for action on proposed Medicare rules for biosimilars
The Biosimilars Forum announced its support for a letter from Congress members to Andrew Slavitt, acting administrator for CMS, regarding proposed provisions for the assignment of billing codes to biosimilars. The letter was cosigned by House Energy and Commerce Committee members Reps. Joe Barton (R-Tex.) and Anna Eshoo (D-Calif.) and a delegation of 33 House members. Read more.
Biosimilar to Rituxan, PF-05280586, comparable to US, EU versions of drug in trial of patients with RA
In a phase 1 and following extension trial, PF-05280586, a biosimilar to Rituxan, demonstrated comparable pharmacokinetic activity to Rituxan as marketed in the U.S. and Europe for patients with rheumatoid arthritis, according to researchers from Pfizer. Read more.