Oncology

Updated Phase 3 Results for CT-P6 Demonstrate the Biosimilar's Safety and Efficacy in Adjuvant Setting

August 21st 2019

By Kelly Davio

This week, researchers reported updated results from a post hoc subgroup analysis from the adjuvant period of treatment in the biosimilar’s phase 3 trial; these results, say the authors, demonstrate that the biosimilar, used in the adjuvant setting, has comparable efficacy and safety to the reference at 1 year.

Court of Appeals for the Federal Circuit Declines to Halt Sales of Biosimilar Bevacizumab

August 19th 2019

By Kelly Davio

Article

In a one-page order filed last week, a panel of judges for the US Court of Appeals for the Federal Circuit denied Genentech’s motion for an injunction that would have blocked Amgen from selling its biosimilar bevacizumab, Mvasi, pending the outcome of an appeal.

Pair of Studies on Pelmeg Confirm Its Biosimilarity to Reference Pegfilgrastim

August 14th 2019

By Kelly Davio

Article

This week, a pair of papers detailing the clinical program for the biosimilar appeared in Pharmacology Research and Perspectives.

Oncology Specialty Pharmacy Teams Can Help Reduce Patients' Financial Toxicity

August 12th 2019

By Allison Inserro

Article

A recent article described a quality improvement project at the oncology specialty pharmacy unit within the University of Chicago Medicine.

Oncology Group Says It Has Begun Treating Patients With Biosimilar Trastuzumab and Bevacizumab

August 8th 2019

By Kelly Davio

Article

OneOncology, a national partnership of community oncology practices, says that its partner practices have begun treating patients with 2 anticancer biosimilars: Kanjinti, a trastuzumab biosimilar referencing Herceptin, and Mvasi, a bevacizumab biosimilar referencing Avastin.

To Promote Biosimilars, Cancer Care Ontario Releases Patient Education Handout

August 5th 2019

By The Center for Biosimilars Staff

Article

The fact sheet is being released as Canada awaits the launch of additional anticancer biosimilars.

Eye on Pharma: Mylan and Biocon Launch Biosimilar Trastuzumab, Ogivri, in Australia

August 3rd 2019

By The Center for Biosimilars Staff

Article

Mylan and Biocon announced this week that they have launched their biosimilar trastuzumab, Ogivri, in Australia. Ogivri, referencing Herceptin, is the first trastuzumab biosimilar to launch in the Australian marketplace and is listed on the nation’s Pharmaceutical Benefit Scheme.

JCR's Proposed Darbepoetin Alfa Biosimilar Performs in Phase 3 Program

July 25th 2019

By The Center for Biosimilars Staff

Article

JCR Pharmaceuticals, together with partner Kissei Pharmaceutical, is currently developing a darbepoetin alfa biosimilar, JR-131, referencing Aranesp. Darbepoetin alfa is used to treat anemia caused by chronic kidney disease or by chemotherapy.

Phase 3 Data for Zirabev Show Similarity of the Biosimilar and Reference Bevacizumab

July 25th 2019

By Kelly Davio

Article

Among the data that supported the biosimilar’s approval was a phase 3 study in patients with advanced nonsquamous non–small cell lung cancer. This week, researchers published detailed findings from that study.

FDA Approves Pfizer's Rituximab Biosimilar, Ruxience

July 23rd 2019

By Kelly Davio

Article

The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.