Biosimilars and Biobetters

Sandoz to Build New Biologics Production Facility in Slovenia

March 17, 2023

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

Eli Lilly to Cap Out-Of-Pocket Insulin Costs at $35

March 02, 2023

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

FDA Accepts Biologics License Application for Proposed Biosimilar Denosumab

February 13, 2023

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

European Commission Approves Bevacizumab Biosimilar from Celltrion Healthcare

August 23, 2022

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

Developing Methods for Analyzing Biosimilars

July 06, 2022

Biosimilar data analysis must demonstrate a correlation between structure and function.

Biocon Biologics to Acquire Biosimilars Assets from Viatris in $3.3 Billion Deal

March 02, 2022

Biocon Biologics will acquire Viatris’ global biosimilars business, including the company’s portfolio of in-licensed biosimilar assets, in a transaction valued at over $3.3 billion.

Samsung Biologics to Acquire Full Ownership of Samsung Bioepis in $2.3 Billion Deal

January 28, 2022

Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.

Biosimilars Gain Traction with Regulators and Manufacturers

September 27, 2021

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

FDA Approves Biosimilar for Treatment of Eye Disease

September 21, 2021

The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

Biosimilars Move to Center Stage

September 02, 2021

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?