The Top 5 Biosimilar Articles for the Week of September 13

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of September 13, 2021.

Number 5: 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.

Number 4: Recent weeks have seen 2 India-based companies announce biosimilar approvals by the Drug Controller General of India (DCGI), with much fanfare.

Number 3: In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contended that originator patents are not the formidable obstacles to biosimilars they are made out to be.

Number 2: Alvotech reported positive top-line results of a study of patients who switched between the company’s proposed high-concentration (100 mg/mL), citrate-free adalimumab biosimilar (AVT02) and the originator product (Humira).

Number 1: Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer a more "rational approach,” according to Sarfaraz K. Niazi, PhD.

To read all of these articles and more, visit centerforbiosimilars.com.