Biosimilar developers achieve key European approvals for denosumab and golimumab, enhancing patient access while facing US ...

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading ...

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and ...

Explore the cost-effectiveness of ranibizumab biosimilars versus aflibercept in treating AMD and DME, revealing significant ...

Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption ...

While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more ...

The FDA has approved Ahzantive (aflibercept-mrbb) as the third biosimilar referencing Eylea (aflibercept) for the treatment of eye conditions, including age-related macular degeneration. Formycon and ...

Reforming patent litigation to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry. The biosimilar market could be accelerated through patent litigation ...

Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential ...

Part 1 of this 3-part series for Global Biosimilars Week focuses on legal barriers to biosimilar access in the US, including the patent system, and discusses ongoing legislative efforts to address ...

In the IQVIA Use of Medicines in the US 2024 report, biosimilars were found to be large contributors to lower drug costs and drivers of market growth; however, these products account for about 23% of ...

November 2025 highlights FDA approvals for denosumab and pertuzumab biosimilars, enhancing competition and access in oncology and bone health markets.