Kelly Davio

September 08, 2017

The FDA has issued new draft guidance on how biologic product sponsors should address postapproval changes in chemistry, manufacturing, and controls.

September 07, 2017

This week, the FDA released a Form 483 noting observations made when inspecting Celltrion’s manufacturing facility in May and June 2017. The heavily redacted form notes 12 observations.

September 06, 2017

The FDA’s Adverse Event Reporting System, which allows healthcare professionals, patients, and others to submit reports on adverse events, contains over 8.5 million entries, a massive number complicated by the fact that any drug may be listed under an average of 16 different names.

September 06, 2017

Seth D. Ginsberg, co-founder of Global Healthy Living Foundation, told The Center for Biosimilars®, “Currently the benefit of rebating and pricing of all infused drugs goes to the payers, health systems, hospitals and physicians, not the patients. Until patients participate in such savings, infused drug pricing has nothing to do with them.”

September 04, 2017

USV, a Mumbai-based pharmaceutical company, announced on Thursday that it had successfully completed phase 1 and phase 3 studies on a proposed pegfilgrastim biosimilar referenced on Neulasta. The company expects to submit data for its marketing authorization application to the European Medicines Agency before the end of 2017.

September 01, 2017

The FDA has granted tentative approval of Sanofi’s follow-on insulin lispro injection, Admelog. Referenced on the originator product, Humalog, Sanofi’s insulin lispro is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes.

September 01, 2017

This week, FDA commissioner Scott Gottlieb, MD, announced that the agency’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) are implementing a new agreement to integrate drug review programs with facility evaluations and inspections.

August 31, 2017

A recent paper published in the World Journal of Gastroenterology examines the complexities posed by biologics and biosimilars in the transition care of adolescent patients who have inflammatory bowel disease (IBD).

August 30, 2017

Biocon announced today in a letter to the National Stock Exchange of India that the FDA has extended its target action date for a regulatory decision on the drug maker’s trastuzumab biosimilar.

August 29, 2017

A recently published study found that the auto-injector device used to deliver a biosimilar etanercept was preferable to the auto-injector device used to deliver reference etanercept (Enbrel) among patients with rheumatoid arthritis and healthcare providers who treat patients with RA.