The Center for Biosimilars Staff

January 24, 2019

Despite the challenges inherent in biosimilars, they have a fairly high probability of success, said Edric Engert, managing director of Abraxeolus Consulting, in a presentation at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.

January 23, 2019

Drug maker Alvotech announced this week that it has raised $300 million, through a private bond offering, that it will used to continue its growth, refinance debt, and further develop its biosimilar pipeline.

January 22, 2019

Sandoz’s biosimilar etanercept, Erelzi, referencing the brand-name Enbrel, has been granted an indication for the treatment of psoriatic arthritis by Health Canada.

January 20, 2019

The European Union has announced that The Committee of the Permanent Representatives of the Governments of the Member States to the European Union (Coreper) agreed this week on the European Council’s draft regulation that grants an exception to Supplementary Protection Certificates (SPCs).

January 19, 2019

In a recent comparability analysis, a proposed biosimilar to etanercept (that the developers hope to sell as Altebrel) underwent direct comparison to the reference and was found to have a high similarity in terms of glycosylation, primary structure, and in-vitro functionality.

January 18, 2019

The Institute for Clinical and Economic Review (ICER), an independent, nonprofit organization that seeks to improve healthcare value by providing comprehensive clinical and cost-effectiveness analyses of treatments, tests, and procedures, has announced that it is undertaking a new annual analysis—an Unsupported Price Increase report—that will review significant prescription drug prices increases and determine whether those increases are supported by new clinical evidence.

January 13, 2019

During this year’s investment symposium, held in San Francisco, California, from January 7-10, biosimilars featured prominently in drug makers’ and regulators’ visions for 2019 and beyond. Here are 7 key takeaways from the conference’s biosimilars presentations.

January 13, 2019

Republic of Korea-based biosimilar developer Alteogen has reported that it has been granted a process patent for its method of producing an aflibercept biosimilar, ALT-L9, referencing Regeneron’s innovator drug Eylea.

January 10, 2019

Following promises of halts to increases in drug prices in 2018, pharmaceutical makers began January by raising the prices of more than 250 drugs. Now, HHS Secretary Alex Azar is calling on companies to bring their list prices back down.

January 07, 2019

Biosimilar developer Samsung Bioepis, a partnership between Samsung BioLogics and Biogen, has announced that it will partner with Chinese biopharmaceutical company 3SBio to develop and commercialize multiple biosimilars in mainland China.