Samantha DiGrande


Biosimilar Trastuzumab CT-P6 Launches in Japan, But Not For Breast Cancer

August 21, 2018

The product did not earn approval for all indications of the reference Herceptin; it has been approved only for the treatment of HER2-positive gastric cancers, and not for the treatment of HER2-positive breast cancer.

European Study: All Biologics Improve Quality of Life in RA, But Rituximab Is Cost-Effective

August 20, 2018

The researchers concluded that rituximab should be considered as a preferred biologic treatment for rheumatoid arthritis (RA) therapy, though treatment of RA with any biologic medication improved quality of life significantly.

Eye on Pharma: JHL Biotech to Begin Phase 3 Trial of Biosimilar Trastuzumab

August 18, 2018

This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted the company positive scientific advice to begin a phase 3 clinical trial of its proposed trastuzumab biosimilar, JHL1188.

Rheumatology and Oncology Providers Voice Concern Over CMS Step Therapy Plan

August 17, 2018

Although the policy change was intended to cut out-of-pocket drug costs for patients, a number of organizations, including the American College of Rheumatology (ACR), have argued that step therapy can be harmful to patients with chronic conditions. On Wednesday, ACR met with HHS Secretary Alex Azar to discuss their concerns.

Eye on Pharma: Bracing for Biosimilars, Genentech Will Lay Off 223 Employees

August 16, 2018

As biosimilar competition nears for Roche and its subsidiary, Genentech, a new WARN notice in the state of California disclosed that Genentech is set to lay off 223 employees from a local plant beginning August 31, 2018.

Irish HTA Official Calls for All New Patients to Start With Biosimilars

August 15, 2018

Clinical director of the Irish health technology assessment (HTA) body National Centre for Pharmacoeconomics (NCP), Michael Barry, MB, FRCPI, PhD, recently said in an interview with Irish media that the lack of uptake of biosimilars in Ireland is “an issue that should be tackled,” and he proposed approaches to do just that.

As Adalimumab Biosimilar Competition Heats Up, AbbVie Sues Sandoz

August 13, 2018

This month, AbbVie filed suit against biosimilar developer Sandoz over its proposed adalimumab (Humira) biosimilar. The suit was filed in the District of New Jersey and alleges infringement under the Biologics Price Competition and Innovation Act.