Jackie Syrop


Research Documents Real-World Experience With Biosimilar Infliximab, Etanercept

November 09, 2017

Three presentations at the 2017 American College of Rheumatology’s Annual Meeting in San Diego, California, covered research on the real-world treatment of rheumatology patients with originator infliximab therapy and biosimilar infliximab (CT-P13; Inflectra and Remsima) and etanercept (Benepali) therapy.

Research Presented on 4 Proposed Etanercept Biosimilars

November 09, 2017

Four presentations on Monday at the 2017 American College of Rheumatology’s (ACR) Annual Meeting in San Diego, California, covered research comparing reference etanercept to 4 proposed biosimilars: SB4, LBEC0101, CHS-0214, and GP2015.

Research Focuses on Proposed Adalimumab Biosimilars

November 06, 2017

Three presentations at this week’s 2017 American College of Rheumatology Annual Meeting in San Diego, CA, cover research on pharmacokinetic equivalence, safety, and switching of 2 proposed adalimumab biosimilars, GP2017 and CHS-1420.

CMS Reverses Its Policy on Biosimilar Reimbursement, Will Issue Unique J-Codes

November 03, 2017

CMS has announced a change to its present policy on biosimilar reimbursement, stating that it will begin issuing unique Healthcare Common Procedure Coding System (HCPCS) codes to each individual biosimilar product.

FDA Agrees to Review sBLA for Reference Bevacizumab

November 02, 2017

The FDA has accepted Genentech’s supplemental Biologics License Application (sBLA) for its innovator bevacizumab (Avastin) in combination with carboplatin and paclitaxel chemotherapy, followed by Avastin alone, for the front-line treatment of women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Momenta and Mylan's Proposed Orencia Biosimilar Fails to Meet Phase 1 Primary PK Endpoints

November 01, 2017

Momenta Pharmaceuticals and Mylan N.V. announced today that M834, the companies’ proposed biosimilar of Bristol-Myers Squibb’s Orencia (abatacept), did not meet its primary pharmacokinetic (PK) endpoints in a phase 1 study comparing the PK, safety, and immunogenicity of M834 compared with US- and EU-sourced Orencia.