Biosimilars | Specialty

The OncLive Biosimilars condition center page is a comprehensive resource for clinical news and expert insights on currently available and investigational biosimilars for reference drugs such as trastuzumab, rituximab, bevacizumab, and more. This page features news articles, interviews in written and video format, and podcasts that focus on updates with biosimilars and ongoing research with these types of agents.


FDA Approves Fifth Trastuzumab Biosimilar

June 14th 2019

The FDA has approved ABP 980 (Kanjinti; trastuzumab-anns), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.

Dr. Schmid on Challenges Concerning Biosimilars in Oncology

May 31st 2019

Peter Schmid, MD, PhD, lead at the Centre for Experimental Cancer Medicine, Barts Cancer Institute, discusses challenges with biosimilars in oncology.

EMA Accepts Application for Trastuzumab Biosimilar

May 29th 2019

The European Medicines Agency has validated and accepted a marketing authorization application for the trastuzumab biosimilar HD201 (Tuznue), according to the developer Prestige BioPharma.

Sandoz Enters Licensing Agreement for Trastuzumab Biosimilar

April 30th 2019

Sandoz has entered into an agreement with EirGenix, Inc., to commercialize the proposed trastuzumab biosimilar EG12014 for use as a treatment of patients with HER2-positive breast and select gastric cancers.

Dr. Pegram on the Development of Trastuzumab Biosimilars

April 29th 2019

Mark D. Pegram, MD, Susy Yuan-Huey Hung Professor, co-director, Stanford's Molecular Therapeutics Program, director, Breast Cancer Oncology Program, Stanford Women's Cancer Center, discusses the development of trastuzumab biosimilars.

Sandoz Resubmits Application for Pegfilgrastim Biosimilar

April 5th 2019

A biologics license application has been resubmitted to the FDA for the pegfilgrastim biosimilar LA-EP2006 to decrease the incidence of infection from febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer therapy.

Dr. Rugo Discusses Regulatory Process Behind Biosimilars

April 3rd 2019

Hope S. Rugo, MD, director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, discusses the regulatory process behind biosimilars in oncology.

Dr. Lyman on the Epoetin Alfa Biosimilar

March 30th 2019

Gary H. Lyman, MD, MPH, medical oncologist, Fred Hutchinson Cancer Research Center, discusses the epoetin alfa biosimilar.

Dr. Lyman on the Process for Approving Biosimilars

March 22nd 2019

Gary H. Lyman, MD, MPH, medical oncologist, Fred Hutchinson Cancer Research Center, discusses the differences in approving a biosimilar and the original biologic product during the 2019 NCCN Annual Conference.

FDA Approves Fourth Trastuzumab Biosimilar

March 12th 2019

The FDA has granted an approval to PF-05280014 (Trazimera; trastuzumab-qyyp), a trastuzumab biosimilar, to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Bridging the Knowledge Gap Between Biosimilars and Biologics in Breast Cancer

March 11th 2019

Since 2006, the European Medicines Agency has granted marketing authorization for more than 40 biosimilars, and, in less than 4 years, the FDA has approved 17, yet the knowledge gap in the understanding of biosimilarity poses a unique challenge to the agents’ assimilation into clinical practice and possible impact on access and cost savings, experts say.

Dr. Janni on the Influence of Biosimilars in Oncology

February 28th 2019

Wolfgang Janni, MD, PhD, professor and chair of the Department of Obstetrics and Gynecology at the University of Ulm, Germany, discusses the influence of biosimilars in oncology.

Bevacizumab Biosimilar Approved in Europe

February 20th 2019

The European Commission has approved PF-06439535 (Zirabev), a bevacizumab (Avastin) biosimilar for the treatment of patients with metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic, or recurrent non–small cell lung cancer, advanced and/or metastatic renal cell cancer, and persistent recurrent or metastatic carcinoma of the cervix.

Dr. Pegram Discusses Challenges Once Biosimilars Hit US Market

January 19th 2019

Mark D. Pegram, MD, Susy Yuan-Huey Hung Professor, co-director, Stanford’s Molecular Therapeutics Program, director, Breast Cancer Oncology Program, Stanford Women’s Cancer Center, discusses challenges biosimilars will face once they hit the United States market.

FDA Approves Third Trastuzumab Biosimilar

January 19th 2019

The FDA has granted an approval to SB3 (Ontruzant; trastuzumab-dttb), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.

Dr. Munster on Developing Biosimilars

January 2nd 2019

Pamela N. Munster, MD, professor, department of medicine (hematology/oncology), University of California, San Francisco (UCSF), director, early phase clinical trials unit, co-leader, Center for BRCA Research, leader, Experimental Therapeutics Program, UCSF Helen Diller Family Comprehensive Cancer Center, discusses the developmental process for biosimilars in oncology.

Dr. Hurvitz on Importance of Biosimilars in HER2+ Breast Cancer

December 29th 2018

Sara A. Hurvitz, MD, director of the Breast Oncology Program, medical director of the Clinical Research Unit, University of California, Los Angeles Jonsson Comprehensive Cancer Center, discusses the importance of biosimilars in HER2-positive breast cancer.

Brufsky Anticipates Significant Cost Reductions With Biosimilars

December 20th 2018

Adam M. Brufsky, MD, PhD, discusses the impact of biosimilars in the field of oncology and outlined other strategies and steps that can be taken to mitigate cost when treating patients with breast cancer.

Biosimilar Filgrastim Would Lower Medicare Out-of-Pocket Expenses

December 19th 2018

Out-of-pocket expenditures are substantially less among Medicare beneficiaries with breast cancer undergoing chemotherapy who receive prophylaxis for febrile neutropenia with a filgrastim biosimilar as opposed to the reference product.

Dr. Brufsky on Ways to Mitigate Cost Before Biosimilars Reach US Market

December 18th 2018

Adam M. Brufsky, MD, PhD, professor of medicine, associate chief, Division of Hematology/Oncology, co-director, Comprehensive Breast Cancer Center, associate director, Clinical Investigation, University of Pittsburgh, discusses cost mitigation practices that can be implemented before more biosimilars reach the United States market.