The Top 5 Biosimilar Articles for the Week of November 6

Here are the top 5 biosimilar articles for the week of November 6, 2023.

Number 5: An international survey found that providers agree that use of biosimilars in inflammatory bowel disease (IBD) is safe and effective in both patients who are treatment-naïve and those who are already being treated with a reference agent.

Number 4: Samsung Bioepis releases data for its denosumab biosimilar candidate; the Community Oncology Alliance (COA) forms the Drug Policy and Regulation Committee; the International Generic and Biosimilar Association (IGBA) and the World Health Organization (WHO) collaborate on a new initiative.

Number 3: On this Biosimilars Roundup episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.

Number 2: The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.

Number 1: The FDA approved Wezlana (ustekinumab-auub), making it the first approval for a biosimilar referencing blockbuster drug Stelara (ustekinumab). The agency also granted Wezlana an interchangeability designation.

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