Oncology

TOT Biopharm's Proposed Bevacizumab Biosimilar Shows PK Similarity to Avastin

September 5th 2019

By Kelly Davio

China-based drug maker TOT Biopharm is developing TAB008 as a biosimilar of the reference bevacizumab, Avastin. TOT has recently indicated that it is in the midst of a phase 3 clinical trial of the biosimilar, and last month, results of a phase 1 study of the biosimilar were published in Frontiers in Pharmacology.

Henlius Investigating Proposed Biosimilar Bevacizumab in Combination With Novel Antibody Targeting PD-1

August 29th 2019

By The Center for Biosimilars Staff

Article

Drug maker Henlius Biotech is recruiting patients for a single-center, open-label, dose-escalation phase 1 clinical trial that will evaluate the safety and tolerability of combination therapy with a biosimilar bevacizumab and an anti–programmed cell death protein 1 (PD-1) antibody in patients with advanced solid tumors.

Data From 11 Head-to-Head Trials Underscore Safety, Efficacy of Biosimilar Rituximab Products

August 28th 2019

By Kelly Davio

Article

A new paper published this month may help to allay some concerns that US providers may have about using FDA-approved biosimilar rituximab.

Reducing Adjuvant Chemotherapy Dose Too Early May Impact Breast Cancer Survival

August 26th 2019

By Allison Inserro

Article

Early dose reductions in the adjuvant chemotherapy combination of 5-fluorouracil, epirubicin, cyclophosphamide, and docetaxel negatively impacted survival rates for patients with intermediate- or high-risk breast cancer.

Given On-Body Injector Failure With Pegfilgrastim, Biosimilar Filgrastim Offers Greatest Cost Efficiency

August 26th 2019

By Kelly Davio

Article

Administering the brand-name pegfilgrastim (Neulasta) via an on-body injection device (sold as Onpro) carries some risk of device failure, resulting in a missed or partial dose of pegfilgrastim. A recent cost simulation found that, when taking this failure into account, assured prophylaxis with biosimilar filgrastim offers the greatest cost efficiency.

Ibrutinib, Rituximab for Patients With CLL Superior to Standard Chemoimmunotherapy

August 23rd 2019

By Allison Inserro

Article

“These results will fully usher the treatment of chronic lymphocytic leukemia [CLL] into a new era,” said Tait Shanafelt, MD, professor of medicine at Stanford. “It seems likely that, in the future, these patients will be able to forego chemotherapy altogether.”

Amgen and Allergan's Proposed Biosimilar Rituximab Shows Clinical Equivalence to Rituxan in NHL

August 23rd 2019

By Kelly Davio

Article

The study in patients with non-Hodgkin lymphoma (NHL) is the second of a pair of studies intended to facilitate regulatory submissions for the proposed biosimilar.

In Extension Study, Patients Exposed to ADCC-Shifted Lots of Reference Trastuzumab Had Lower EFS Rate

August 22nd 2019

By Kelly Davio

Article

When Samsung Bioepis’ trastuzumab biosimilar, SB3 (Ontruzant), gained regulatory approval in multiple highly regulated markets, it did so on the strength of a data package including evidence from a phase 3 study in patients with HER2-positive early breast cancer. Later, it became apparent that some of the patients who received the reference product in the phase 3 study had been exposed to lots of Herceptin with a marked shift in relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

Study Looks Favorably at Adding Rituximab to Primary Central Nervous System Lymphoma Treatment

August 22nd 2019

By The Center for Biosimilars Staff

Article

A recent study suggests that adding rituximab to a high‐dose methotrexate‐based combination chemotherapy could prolong overall survival as well as progression-free survival for patients with primary central nervous system lymphoma, a rare and aggressive form of lymphoma.

Patients With DLBCL See No Additional Gains With Maintenance Rituximab After CHOP

August 21st 2019

By The Center for Biosimilars Staff

Article

A recent study found that rituximab maintenance therapy provides no additional benefit for patients with diffuse large B‐cell lymphoma (DLBCL) who are in complete remission after receiving rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy.