Researchers report that biosimilar use was not influenced by disease type but correlated with treatment sequence, shorter ...
The FDA has approved Celltrion's Eydenzelt, a new aflibercept biosimilar, enhancing treatment options for retinal diseases in the US.
A recent study confirms the stability of XSB-001 biosimilar for retinal diseases under realistic clinical handling conditions ...
A review of the safety of biosimilar DMARDs during pregnancy reveals critical evidence gaps and the need for informed clinical guidance.
Biosimilars have delivered substantial cost savings and broadened patient access across Europe. However, stakeholders now face the growing risk of a “biosimilar void”—a scenario in which 90% of the ...
New research highlights the efficacy and high patient satisfaction of adalimumab biosimilars in treating inflammatory diseases. In response to the need for more real-world evidence on adalimumab ...
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 ...
To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the ...
The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the ...
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 ...
Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the ...
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