Development

The BPCIA and the Naming of Biosimilars

October 10th 2018

Comparison of Biologics to Biosimilars Versus Generics

October 10th 2018

Fresenius Kabi's Biosimilar Pegfilgrastim Meets Primary Endpoints in 2 Studies

October 9th 2018

By Kelly Davio

Fresenius Kabi announced today that its MSB11455, a proposed pegfilgrastim biosimilar referencing Neulasta, met its primary endpoints in 2 clinical studies that are intended to facilitate regulatory applications for the product in the United States and the European Union.

Fresenius Kabi Exec Weighs in on the Need for Clinical Trials of Biosimilars

September 28th 2018

By Kelly Davio

Recent weeks have seen heightened debate over the need for phase 3 confirmatory trials for biosimilars, with some stakeholders calling these trials unnecessary and others going so far as to call them unethical. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Uwe Gudat, MD, who serves as head of clinical safety and pharmacovigilance at Fresenius Kabi, weighed in. “The subject I raise is rather provocative,” he acknowledged.

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.