Since 2006, the European Union has approved 23 biosimilars, 16 of which are used in cancer; examples of recent approvals are CT-P10 and L01XC02, which are biosimilars of rituximab. 26 Worldwide, more ...

Patent settlements accelerate the entry of generics and biosimilars, saving the health care system $422.9 billion and ...

Opinions expressed are those of the author. Biosimilars are gaining traction as competitors aim to capture market share from branded biologics such as Humira and Neulasta. Humira now faces ...

Selarsdi, a human interleukin-12 and -23 antagonist, is currently indicated for: The FDA originally approved Selarsdi as a biosimilar for plaque psoriasis and psoriatic arthritis in April 2024 ...

The FDA approved omalizumab-igec (Omlyclo) as the first biosimilar for omalizumab (Xolair) and the first for any respiratory condition in the U.S., drugmaker Celltrion announced Monday.

The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes, the agency announced Friday. Like its reference ...

Biosimilar developers have benefited from many recent advances. Notable examples highlighted by Meyer include single-use bioreactors, which reduce the risk of cross-contamination across all scales; ...

Please provide your email address to receive an email when new articles are posted on . The expansion of safe and effective FDA-approved biosimilars for inflammatory bowel disease set to launch in ...

The US Food and Drug Administration (FDA) has approved ustekinumab-kfce (Yesintek) as a biosimilar to ustekinumab (Stelara) for the treatment of Crohn’s disease, ulcerative colitis, plaque ...

The redesign still favors high-list reference products over biosimilars. For example, a high-list-price reference product with a 55% rebate had a lower net cost than a lower-list-price biosimilar ...

Delayed biosimilar uptake in the US is driven by payer, provider, and patient barriers, but targeted interventions can help boost utilization and savings. As prices have increased for biologic ...

A biosimilar drug manufacturer is concentrating ... techniques that BioFactura has adopted to cut costs as, for example, intensified perfusion which, according to Hausfeld, uses more expensive ...