Latest Conference Articles

Cinfa Biotech's B12019 Similar to Neulasta in Terms of PD, Immunogenicity

Samantha DiGrande

December 7 2017

A recent study found that Cinfa Biotech’s proposed pegfilgrastim biosimilar, B12019, has similar pharmacodynamics (PD) and immunogenicity to the reference Neulasta.

Rapid Infusion of Biosimilar Rituximab Safe, Well Tolerated

Samantha DiGrande

December 6 2017

Patients can be switched from reference rituximab (MabThera) to biosimilar rituximab (Truxima) without reverting to slower infusion rates, according to a new study.

Study Shows Low Incidence of Immunogenicity With Tbo-Filgrastim

The Center for Biosimilars Staff

December 6 2017

A new study, conducted by Linglong Zou, PhD, and colleagues, evaluates the immunogenicity of tbo-filgrastim in patients receiving chemotherapy for solid and hematologic malignancies.

Savings From Biosimilar Filgrastim Can Expand Access to High-Cost Drugs

Samantha DiGrande

December 5 2017

At the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Sanjeeev Balu, PhD, will present results of a study that examines expanded access to the drug obinutuzumab (Gazyva) made possible on a budget-neutral basis through savings obtained from using biosimilar filgrastim-sndz (Zarxio).

Argentine-Approved Biosimilar Rituximab Has Similar Safety Profile to Its Reference

Samantha DiGrande

December 5 2017

Since Novex’s commercial launch, the first national pharmacovigilance plan for a biosimilar monoclonal antibody has been implemented, and data from this post-marketing surveillance show that, in terms of tolerability, this biosimilar has a similar safety profile to that of the reference product.

New Data Support the Use of Tbo-Filgrastim in Pediatric Patients

Kelly Davio

December 5 2017

On Sunday, December 10, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Noah Federman, MD, will present research from a phase 2 study on the use of subcutaneous tbo-filgrastim (Granix) in pediatric patients with solid tumors who are undergoing chemotherapy.

Financial Incentives May Lead to Overuse of Rituximab Maintenance

Kelly Davio

December 4 2017

On Saturday, December 9, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Scott Huntington, MD, MPH, will present his research team’s findings that the receipt of lymphoma care in the community-based setting is associated with guideline-discordant use of rituximab.

An Industry Perspective on Biosimilar Interchangeability

Kelly Davio

November 17 2017

In a Thursday session of the SMi Biosimilars North America 2017 conference, Cindy Cao, PhD, executive director and head of United States regulatory affairs at Sandoz, looked ahead to the advent of interchangeable biosimilars.

Originator Biologics Manufacturers "Bi-Vest" in Biosimilars

Kelly Davio

November 16 2017

Mkaya Mwamburi, MD, PhD, MA, president and CEO of the biotechnology consulting firm profecyINTEL, said in a presentation at the 2017 SMi Biosimilar North America conference that manufacturers of originator biologics are taking the lead on biosimilar development.

Biosimilar Uptake Hinges on Prescriber, Patient, and Payer

Kelly Davio

November 16 2017

In a Wednesday session of the SMi Biosimilars North America 2017 conference, Gary Cupit, PharmD, senior advisor to the investment bank Frontcourt Group, gave biosimilar manufacturers his perspective on the market access challenges facing biosimilar developers.