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.

Dr. McBride on the Potential Impact of Bevacizumab Biosimilars in Oncology

August 9th 2019

Ali McBride, PharmD, MS, BCOP, Clinical Coordinator of Hematology/Oncology, The University of Arizona Cancer Center, and President-Elect of the Association of Community Cancer Centers (ACCC), discusses the potential impact of bevacizumab (Avastin) biosimilars in oncology.

Dr. Lyman on Biosimilars Reducing Healthcare Costs in the United States

August 8th 2019

Gary H. Lyman, MD, MPH, senior lead, Health Care Quality and Policy, Hutchinson Institute for Cancer Outcomes Research, member, Cancer Prevention Program, Public Health Services Division, and member, Clinical Research Division, Fred Hutchinson Cancer Research Center, discusses the presence of biosimilars on the market and their potential to reduce healthcare costs in the United States.

FDA Approves Rituximab Biosimilar for CD20+ B-Cell Non-Hodgkin Lymphoma and CLL

July 23rd 2019

The FDA has approved PF-05280586, a biosimilar for rituximab, for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy, or for patients with CD20-positive chronic lymphocytic leukemia in combination with chemotherapy.

FDA Approves Bevacizumab Biosimilar

June 28th 2019

The FDA has approved PF-06439535, a bevacizumab biosimilar, for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent, or metastatic cervical cancer.

Biosimilars in Cancer Care: Potentially Improving Patient Access to Essential Therapies9,10

June 17th 2019

Gary Fanjiang, MD, vice president of Biosimilars Global Development, Amgen, discusses the development of biosimilars and some of the clinical considerations related to their use.

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.