Here are the top 5 biosimilar articles for the week of April 17, 2023.
Hi, I’m Justina Petrullo 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 April 17th, 2023.
Number 5: The Committee for Medicinal Products for Human Use gave a thumbs up for an eculizumab biosimilar, and a biologic license application for a bevacizumab biosimilar was accepted in Brazil.
Number 4: A retrospective real-world study assessing patient outcomes related to switching from reference rituximab (Rituxan) to a biosimilar version (Truxima) found that transitioning between the products was safe for patients and did not result in a change in adverse events.
Number 3: Celltrion Healthcare shared data from a phase 3 clinical trial confirming that its omalizumab biosimilar had comparable safety and efficacy to the reference product (Xolair).
Number 2: In a complete response letter (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further delaying the approval for the ninth adalimumab biosimilar until potentially June 2023.
Number 1: The misconceptions about disposable bioreactors' lifecycle are gone; the era of hard-piped, giant, stainless-steel tanks for biosimilar development is history now, according to Sarfaraz K. Niazi, PhD, in his latest column.
To read all of these articles and more, visit centerforbiosimilars.com.