Oncology

NICE: Pertuzumab Not Cost-Effective, Even When Used With Biosimilar Trastuzumab

August 20th 2018

By The Center for Biosimilars Staff

The National Institute for Health and Care Excellence (NICE) evidence reviewers considered a biosimilar discount of 70% to 90% off the reference trastuzumab’s price at a 90% to a 100% market share, and the Cancer Drugs Fund provided the committee with confidential information on the weighted average price and market share for available biosimilar trastuzumab products.

Patient-Administered Biosimilar and Follow-On Filgrastim Pose Opportunity for Savings

August 13th 2018

By Kelly Davio

Article

Studies have demonstrated that using follow-on and biosimilar granulocyte colony-stimulating factor (G-CSF) agents can produce cost savings and expand patient access to prophylaxis of febrile neutropenia. Now, a newly published budget impact analysis finds that even greater savings may be possible if patients self-administer these agents at home rather than visiting a provider to receive an injection.

Tbo-Filgrastim Gains a New Pediatric Indication and Vial Presentation

August 9th 2018

By The Center for Biosimilars Staff

Article

Teva announced this week that the FDA has approved its tbo-filgrastim (Granix), a follow-on product referencing Neupogen, to reduce the duration of severe neutropenia in patients as young as 1 month old who have nonmyeloid malignancies and are receiving myelosuppressive chemotherapy.

Pfizer's Trastuzumab Biosimilar, Trazimera, Authorized by European Commission

July 31st 2018

By Kelly Davio

Article

Pfizer announced today that the European Commission (EC) has approved its trastuzumab biosimilar, Trazimera, referencing Herceptin, for marketing. The approval makes Trazimera the fourth trastuzumab biosimilar (following Kanjinti, Ontruzant, and Herzuma) to be approved by the EC, and the first approval of an anticancer biosimilar for Pfizer.

Mylan Confirms That It Has Launched Fulphila in the United States

July 30th 2018

By The Center for Biosimilars Staff

Article

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

Article

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

Article

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

Article

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

Article

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

Article

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