Oncology

Administering Nivestym at Home Is Effective and Well-Received by Patients

October 18th 2018

By Kelly Davio

A recent study provides insight into the feasibility of at-home administration of biosimilar filgrastim—Pfizer’s recently approved Nivestym—an option that has the potential to reduce patient burden associated with hospital administration.

ODAC Unanimously Recommends Celltrion's Biosimilar Rituximab for FDA Approval

October 10th 2018

By Samantha DiGrande

Article

In a vote on whether the totality of the evidence supported the licensure of CT-P10 as a biosimilar to Rituxan, all 16 Oncologic Drug Advisory Committee (ODAC) members voted yes, for reasons some enumerated as “overwhelming biosimilarity and clinical trial evidence” that “really sealed the deal.”

Association of European Cancer Leagues Calls for Faster Biosimilar Uptake

October 10th 2018

By The Center for Biosimilars Staff

Article

The Association of European Cancer Leagues, a nonprofit, pan-European organization of national and regional cancer societies, has issued a new white paper that calls for greater biosimilar use as a means to reduce costs and increase patient access to cancer treatment.

Ahead of ODAC Meeting, FDA Documents Say CT-P10 is Highly Similar to Rituxan

October 8th 2018

By Samantha DiGrande

Article

The FDA's Oncologic Drugs Advisory Committee (ODAC) briefing documents state that the totality of the evidence suggests that the proposed biosimilar is highly similar to its US-licensed reference, despite minor differences in clinically inactive compounds.

Pfizer Launches Biosimilar Filgrastim, Nivestym, at a Substantial Discount

October 3rd 2018

By Kelly Davio

Article

Pfizer indicated that Nivestym will be priced at a wholesale acquisition cost (WAC) of $350.40 per 480-mcg prefilled syringe, a WAC that is 30.3% lower than that of the reference Neupogen.

Health Canada Approves Trastuzumab for Subcutaneous Administration

October 1st 2018

By Kelly Davio

Article

Health Canada has approved a formulation of Roche’s originator trastuzumab, Herceptin, that is intended for subcutaneous administration. The drug, indicated to treat HER2-positive cancers, can be administered in 2 to 5 minutes (versus an average of 90 minutes for intravenous administration).

European Commission Authorizes Coherus' Pegfilgrastim Biosimilar, Udenyca

September 25th 2018

By The Center for Biosimilars Staff

Article

The product is the first pegfilgrastim biosimilar to be authorized by the European Commission and the first Coherus product to be cleared by a regulatory authority.

BEVZ92 Highly Similar to Reference Bevacizumab in PK, Efficacy, Immunogenicity, and Safety

September 25th 2018

By Kelly Davio

Article

Notably, the study was conducted in patients with cancer, rather than in a healthy population, to generate evidence of pharmacokinetic (PK) equivalence in a scenario that reflects how the biosimilar would be used in clinical practice.

Iranian Biosimilar Rituximab Noninferior to Its Reference in Treating CLL

September 24th 2018

By The Center for Biosimilars Staff

Article

A recently published study between the biosimilar and the reference rituximab, MabThera, demonstrated that the biosimilar was noninferior to the reference in terms of both efficacy and safety in treating chronic lymphocytic leukemia (CLL).

Sandoz, Cinfa, Mylan All Receive CHMP Recommendations for Pegfilgrastim Biosimilars

September 21st 2018

By Kelly Davio

Article

Today, Sandoz, Cinfa Biotech, and Mylan all revealed that they have received positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for proposed pegfilgrastim biosimilars referencing Neulasta.