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 Approvals in GBM, Biosimilar in Breast Cancer and Gastric/GEJ Cancer, and Biomarker Assay

December 8th 2017

FDA Approves Trastuzumab Biosimilar

December 1st 2017

The FDA has approved the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst), which now has has approved indications for HER2-positive patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma.

Bevacizumab Biosimilar Nears European Approval

November 11th 2017

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of the bevacizumab biosimilar ABP 215 for the treatment of patients across several tumor types.

Follicular Lymphoma: Audience Q&A

October 21st 2017

Follicular Lymphoma: Complexities in Combinations

October 21st 2017

Follicular Lymphoma: Considering All Novel Agents

October 21st 2017

FL: The Impact of Data from Clinical Trials

October 21st 2017

Follicular Lymphoma: Challenges in Moving Forward

October 21st 2017

Follicular Lymphoma: Optimizing Copanlisib

October 21st 2017

Follicular Lymphoma: Defining Copanlisib

October 21st 2017

Follicular Lymphoma: Overview of Treatment Options

October 21st 2017

Follicular Lymphoma: Outcomes with Immunotherapy

October 21st 2017

Priority Review Designation in NSCLC, Fast Track Designation in AML, CRL Issued for a Biosimilar, and More

October 13th 2017

FDA Issues Complete Response Letter for Pegfilgrastim Biosimilar

October 10th 2017

Biocon has announced that the FDA has issued a complete response letter for Mylan’s biologics License Application for MYL-1401H, a proposed biosimilar for Amgen’s pegfilgrastim (Neulasta).

FDA Approves First Biosimilar for Cancer Treatment

September 14th 2017

The FDA approved the first biosimilar for the treatment of cancer. ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin), is indicated for the treatment of colorectal, lung, brain, kidney, and cervical cancers in adult patients.

FDA Accepts Application for Rituximab Biosimilar

September 12th 2017

The FDA has accepted a biologics license application for the rituximab biosimilar Rixathon, according to Sandoz, the company developing the treatment.

FDA Delays Decision on Trastuzumab Biosimilar MYL-1401O

August 30th 2017

The FDA has extended its decision deadline by 3 months on a biologics license application for MYL-1401O, a trastuzumab biosimilar co-developed by Mylan and Biocon. A final decision is expected on or before December 3, 2017.

ODAC Votes to Recommend Approval for Trastuzumab Biosimilar MYL-1401O

July 14th 2017

The FDA’s Oncologic Drugs Advisory Committee voted 16-0 to recommend approval to MYL-1401O, the trastuzumab (Herceptin) biosimilar manufactured by Mylan Pharmaceuticals.

ODAC Unanimously Supports Bevacizumab Biosimilar ABP-215

July 13th 2017

The FDA’s Oncologic Drugs Advisory Committee voted 17-0 to recommend approval for ABP-215, a biosimilar for bevacizumab (Avastin) to treat a range of solid tumors.

FDA Issues Complete Response Letter for Epoetin Alfa Biosimilar

June 23rd 2017

The FDA has rejected Hospira's a biologics license application for the epoetin alfa biosimilar, epoetin hospira, citing manufacturing concerns at the company's fill-finish facility in McPherson, Kansas.