The Top 5 Biosimilar Articles for the Week of March 17

Number 5: Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.

Number 4: Biocon’s ustekinumab biosimilar matched reference ustekinumab in efficacy and safety, while an adalimumab biosimilar proved interchangeable with reference adalimumab, according to posters at the American Academy of Dermatology (AAD) annual meeting.

Number 3: The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.

Number 2: With 4 already on the market, 2 more ustekinumab competitors are joining the fray, expanding access to lower-cost alternatives to blockbuster originator biologic, Janssen’s Stelara.

Number 1: Sarfaraz Niazi, PhD, urges the FDA to let the US Pharmacopeia (USP) create product release specifications for biosimilars to cut costs, speed development, and enhance accessibility.

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