FDA approves Xbrane’s Lucentis biosimilar

The US Food and Drug Administration (FDA) has approved a new manufacturing process for SIMLANDI, Alvotech’s biosimilar to Humira, that more than doubles drug substance output per batch at the company’s facility in Reykjavik.

Alvotech and its partner Advanz Pharma have submitted a European regulatory application for AVT29, a proposed biosimilar to the high-dose retinal disease drug Eylea 8 mg. According to the companies, it is the first known submission of its kind worldwide.

Health Canada has approved Camurus’s Oczyesa XR, a once-monthly subcutaneous octreotide depot, for maintenance treatment of adults with acromegaly who have responded to and tolerated treatment with somatostatin analogs.

Finnish clinical-stage biotech Desentum has closed an oversubscribed EUR 28 million equity round to advance its allergy vaccines.

Icelandic biosimilar developer Alvotech has signed a long-term manufacturing agreement with LOTTE Biologics for US-based production. A day earlier, the FDA approved a second production suite in Reykjavik for its Humira biosimilar SIMLANDI.

Beactica Therapeutics has selected BEA-28 as a preclinical candidate in its TEAD program, which aims to develop new therapies for aggressive, hard-to-treat solid tumors, including cancers that have become resistant to existing treatments.

Hansa Biopharma has signed a collaboration with Amsterdam-based Cradle. Hansa will use Cradle's AI-driven protein design and engineering platform across its research and development work to develop new immunomodulatory treatments for severe autoimmune diseases.