The Top 5 Biosimilar Articles for the Week of September 22

Number 5: The FDA has approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), the sixth pair of denosumab biosimilars to receive the green light from the agency. The approvals, granted to Biocon Biologics, will provide more affordable treatment options for people with osteoporosis and cancer-related bone conditions.

Number 4: Doctors in China are seeing encouraging results with HLX02, a trastuzumab biosimilar that may help expand access to treatment for people with HER2-positive metastatic breast cancer, as a new real-world study from Fudan University Shanghai Cancer Center found it worked as well and was just as safe as the originator, even for patients who switched mid-treatment.

Number 3: Patients with inflammatory bowel disease (IBD) who transitioned from reference adalimumab (Humira) to the biosimilar Amgevita (adalimumab-atto) maintained stable disease control and generated substantial drug cost savings, according to a single-center prospective cohort study from Galway University Hospitals in Ireland.

Number 2: A new biosimilar, SYSA1902, shows comparable efficacy and safety to ustekinumab for treating moderate-to-severe plaque psoriasis, expanding patient options.

Number 1: Sarfaraz K. Niazi, PhD, highlights the FDA’s move to waive costly clinical efficacy studies for biosimilars as a turning point that will lower development costs, drive big pharma out, and open the market to smaller companies, making biosimilars more affordable and accessible like generics.