Oncology

Mylan Confirms That It Has Launched Fulphila in the United States

July 30th 2018

By The Center for Biosimilars Staff

Drug maker Mylan, which in June received FDA approval for its biosimilar pegfilgrastim, Fulphila, confirmed in an email to The Center for Biosimilars® that it has launched the biosimilar in the United States marketplace. Fulphila is the fourth biosimilar—and the first pegfilgrastim biosimilar—to become available to US patients.

FDA Approves Second Neupogen Biosimilar, Nivestym

July 20th 2018

By Kelly Davio

The FDA has approved Pfizer's filgrastim-aafi, a filgrastim biosimilar to Amgen's Neupogen. The product, the second filgrastim biosimilar approved in the United States, will be sold under the brand name Nivestym.

Mylan to Launch Fulphila at 33% Discount to Neulasta

July 17th 2018

By Kelly Davio

In an email to The Center for Biosimilars®, Mylan confirmed that it will launch its biosimilar pegfilgrastim at a wholesale acquisition cost (WAC) of $4175 per syringe, a price that reflects a 33% discount to the WAC of Amgen’s reference product, Neulasta.

Consequences of Switching to Anticancer Biosimilars Are "Unknown," Concludes Appraisal

July 16th 2018

By Kelly Davio

Biosimilars of anticancer monoclonal antibodies are emerging in the therapeutic landscape, and while the body of evidence concerning switching to supportive care biosimilars—epoetin and filgrastim biosimilars—is robust, there are fewer data available concerning a switch to biosimilars of products such as rituximab, trastuzumab, and bevacizumab.

Intratumoral Injections of Bevacizumab Could Help Prevent AEs Associated With Systemic Therapy

July 3rd 2018

By The Center for Biosimilars Staff

Intravenous administration of the anti–vascular endothelial growth factor treatment bevacizumab at high doses can result in serious, systemic adverse events (AEs). Additionally, tumors can become resistant to therapy and adopt a more invasive growth pattern. Thus, delivering bevacizumab for the treatment of cancer at a lower dose in a manner that avoids systemic AEs is necessary.

Trastuzumab Usage in China Remains Low Compared With United States, Europe

July 2nd 2018

By Samantha DiGrande

The presence or absence of insurance coverage for trastuzumab treatment was the strongest predictor of trastuzumab therapy use in Chinese patients.

Report Details Novel Methods to Improve Clinical Use of CAR T-Cell Immunotherapies

June 25th 2018

By Jackie Syrop

Researchers have reported the development of CubiCAR architecture, which has the potential to improve the safety of chimeric antigen receptor (CAR) T-cell immunotherapies for a broad range of patients with cancer.

5 Biosimilars Takeaways From ASCO 2018

June 10th 2018

By The Center for Biosimilars Staff

The American Society of Clinical Oncology’s (ASCO) annual meeting, held June 1-5, 2018, in Chicago, Illinois, featured results of numerous studies on biosimilars in anticancer and supportive care. Here are 5 key takeaways from the meeting.

The Top 5 Biosimilars Articles for the Week of June 4

June 8th 2018

The Center for Biosimilars® recaps the top 5 articles for the week of June 4, 2018.

New Directions in Oncology Biosimilars

June 8th 2018

By Jaime Rosenberg

During a session at the 2018 American Society of Clinical Oncology Annual Meeting, held June 1-5 in Chicago, Illinois, researchers gave a glimpse into new directions in oncology biosimilars through providing results on several studies testing the safety, efficacy, and usage of different biosimilars.