Development

In Brazil, Government and Industry Partner to Develop Biosimilars

September 21st 2018

By The Center for Biosimilars Staff

Brazil benefits from a program, known as the Partnership for Productive Development, that brings together government and the private sector to develop strategic products of interest to the Brazilian health system—including biosimilars of high-cost biologics that account for approximately half of annual drug spending.

Researchers Report Positive Early Data for Cetuximab Biosimilar

September 18th 2018

By The Center for Biosimilars Staff

Cetuximab (Erbitux), an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody used in the treatment of head and neck and colorectal cancer, so far faces no biosimilar challengers. However, Chinese researchers are reporting positive preclinical results for a proposed biosimilar, APZ001.

Sandoz's Carlos Sattler, MD, Shares His Perspective on Biosimilar Development

August 27th 2018

By Kelly Davio

Sandoz, with its filgrastim biosimilar (Zarxio) having been the first biosimilar to gain FDA approval and to launch in the US market, has had extensive experience in the biosimilars space. Carlos Sattler, MD, head of clinical development and medical affairs at Sandoz, recently spoke with The Center for Biosimilars® about both the biosimilar development process and the regulatory landscape that lies ahead.

Phase 3 Trials May Be Unnecessary for Biosimilars, Paper Argues

August 21st 2018

By Kelly Davio

“It is now time to reassess whether the current clinical development paradigm really makes sense from a scientific and economic perspective while millions of patients still have limited or, more often, no access to life-changing/life-saving [monoclonal antibodies],” writes Francois-Xavier Frapaise, MD, PhD.

Two Trials of Low-Dose Rituximab Have Implications for Biosimilarity Testing

August 1st 2018

By Kelly Davio

The researchers hypothesized that currently used doses of rituximab, of 375 mg/m2 or greater, significantly exceed the half-maximal effective dose of rituximab, at which differences between a biosimilar and the reference would be most likely to be found.

AAPS White Paper Provides Guidance on Analytical Similarity Evaluations of Biosimilars

May 17th 2018

By Kelly Davio

The American Association of Pharmaceutical Scientists (AAPS), a professional organization of 9000 scientists, has published a new white paper in The AAPS Journal that discusses the scientific and methodological considerations of the process of attribute and test method selection, criticality assessment, and assignment of analytical measures to the FDA’s 3 tiers of analytical similarity assessment for biosimilars.

Is the White House Budget at Odds With NIH's Contributions to New Drugs?

February 13th 2018

By Samantha DiGrande

Yesterday, President Trump released his budget proposal for the 2019 fiscal year. On the same day, the Proceedings of the National Academy of Sciences of the United States of America released a paper summarizing the NIH’s contribution of funding to new drugs approved from 2010 to 2016.

Robert Cerwinski: Reference Product Sponsors and Biosimilar Development

November 29th 2017

Robert Cerwinski, JD, partner at Goodwin, discusses the challenges that reference product sponsors encounter when they also seek to develop biosimilars.

European Union Launches Consultation on Patent Extension

October 19th 2017

By The Center for Biosimilars Staff

SPCs are an intellectual property right that grants an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical. The goal of the SPC is to offset the loss of patent protection that occurs during the development and clinical trials of a generic or biosimilar.

Paper Argues That Bridging Studies Are Redundant, Unnecessary

August 18th 2017

By Kelly Davio

A recent paper, published in BioDrugs, argues that, in biosimilar development, bridging studies between locally licensed and internationally licensed reference biologics may be unnecessary.