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…
In the Journals

Switching from Remicade to biosimilar Inflectra safe, effective through 1 year in IBD

December 7, 2017
Patients with inflammatory bowel disease who switched from Remicade to Inflectra showed no differences in drug levels or disease activity through 1…
FDA News

FDA approves Ogivri, first biosimilar for certain breast, stomach cancers

December 1, 2017
The FDA today approved trastuzumab-dkst, the first biosimilar to treat patients with breast cancer or gastric or gastroesophageal junction…
Meeting News

Remicade biosimilar Inflectra shows safety, efficacy through 1 year in IBD

November 3, 2017
Patients with inflammatory bowel disease who switched from Remicade to its biosimilar Inflectra — marketed as Remsima in the U.K. — or…

Biosimilars may reduce US health care spending by $54 billion

October 23, 2017
A study recently published by the RAND Corporation showed biosimilars may lead to a reduction in health care spending in the United States on…