© 2021 MJH Life Sciences and Center for Biosimilars®. All rights reserved.
© 2021 MJH Life Sciences™ and Center for Biosimilars®. All rights reserved.
September 25, 2021
Biosimilar User Fee Act reviews have been slowed by the pandemic and the FDA has opened a public comment period as it plots the course through 2027.
September 24, 2021
September 23, 2021
September 22, 2021
September 15th 2021
By Tony Hagen
The “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA) is meant to resolve litigation efficiently, and it does, although in practice biosimilar developers and originator companies may not completely adhere to the prescribed steps, according to Biotechnology Innovation Organization (BIO) experts.
September 14th 2021
The positive findings for the trastuzumab biosimilar Ontruzant in patients with human epidermal growth factor receptor 2 (HER2)–positive early or locally advanced breast cancer were presented at the European Society for Medical Oncology (ESMO) Congress 2021.
The Alliance for Safe Biologic Medicines (ASBM) has fought since 2010 in opposition of payer policies that promote automatic switching to cheaper biologics including biosimilars. The group's new chair is no newcomer to this battle.
September 13th 2021
Companies that gain Drug Controller General of India (DCGI) marketing authorization are likely in for much more extensive trials if they hope to commercialize their biosimilars on the global platform.
September 11th 2021
By Sarfaraz K. Niazi, PhD
Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer what the author considers a more "rational approach."
September 10th 2021
Here are the top 5 biosimilar articles for the week of September 6, 2021.
September 9th 2021
The findings support Alvotech's bid for interchangeable status for the high-concentration, citrate-free adalimumab biosimilar candidate.
The strength of a patent wall built up around an originator biologic depends on the quality of patents that make it up and the originator company's willingness to engage in costly litigation. Part 2 of a series.
September 8th 2021
In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.
September 7th 2021
Shanghai Henlius Biotech, Innovent Biologics, and other Chinese biopharmaceutical makers are leading the wave of Asia-Pacific (APAC) biosimilar development, according to a GlobalData analyst.