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Samsung Bioepis' Bevacizumab Is Cleared for Launch in Europe
Samsung Bioepis' latest approval gives it 5 biosimilar approvals in the European marketplace.
The European Commission (EC) has given marketing approval for the bevacizumab biosimilar Aybintio, by Samsung Bioepis.
The Incheon, Republic of Korea—based company said the EC has indicated the drug for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, non–small cell lung cancer, advanced or metastatic renal cell cancer, epithelial ovarian, fallopian tube and primary peritoneal cancer, and cervical cancer. These encompass all approved indications for the reference product, Avastin.
The company noted the drug was approved based on analytical, pharmacokinetic, and clinical data, as well as pharmacology and toxicology data, all of which demonstrated that Aybintio and the reference product are highly similar with no clinically meaningful differences.
“Approval of Aybintio provides another treatment option for patients with certain types of cancers, enabling wider access to those in need,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis, expressing pride in the drug authorization achievement.
Samsung Bioepis now has 5 biosimilars approved for use in Europe. These include Benepali (etanercept), Flixabi (infliximab), Ontruzant (trastuzumab), and Imraldi (adalimumab).
In June, Aybintio was recommended for approval by Europe's Committee for Medicinal Products for Human Use.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.
