Sandoz obtains positive CHMP opinion for Remicade biosimilar

March 23, 2018
Sandoz received a positive opinion the European Medicines Agency’s Committee for Medicinal Products for Human Use for its proposed infliximab…
In the Journals

Switching from Humira to biosimilar Cyltezo safe, effective in RA

March 16, 2018
Patients with rheumatoid arthritis who switched from adalimumab to the biosimilar adalimumab-adbm experienced no significant differences in efficacy…
In the Journals

Biologic use before, during pregnancy not linked to preterm birth

March 15, 2018
The use of biologic medications for autoimmune diseases prior to or during pregnancy is not associated with an increased risk for preterm delivery or…

ACR, physician groups warn HHS against new pricing proposals for biologics

March 14, 2018
The American College of Rheumatology has joined eight other national physician groups in calling on HHS to reconsider a series of new drug pricing…
FDA News

Gottlieb denounces 'rigged' rebate system restricting biosimilar access

March 8, 2018
FDA Commissioner Scott Gottlieb, MD, on Wednesday took aim at the current rebate contracting system for being “rigged against”…
In the JournalsPerspective

Biosimilar competition in U.S. limited by accumulative regulatory failures

March 8, 2018
Despite the expedited pathway for biosimilars enacted by the Biologics Price Competition and Innovation Act of 2009, the development of competition…


Meeting News

Real-world Crohn’s study shows genetic link to immunogenicity, biosimilar equivalence

February 21, 2018
Patients with Crohn’s disease who carried an HLA-DQA1*05 haplotype showed an increased risk for developing immunogenicity to anti-tumor…

Biosimilar PF-05280586 equivalent to rituximab for follicular lymphoma

January 24, 2018
PF-05280586, a potential biosimilar to rituximab, met its primary endpoint of overall response rate in a clinical trial of patients with…

FDA resources can help prescribers better understand biosimilars

January 19, 2018
by Leah Christl, PhD The Biologics Price Competition and Innovation Act, included within the Affordable Care Act, established an abbreviated…