BiosanaPharma B.V. is a private, Netherlands-based, clinical-stage biologics company developing a phase III-ready Xolair® (omalizumab) biosimilar, AVT23 (also called BP001) on a highly disruptive, proprietary cGMP continuous “3C” manufacturing platform.

Xolair® is an anti-allergy monoclonal antibody and the current standard of care for the treatment of severe allergic asthma and chronic spontaneous urticaria. Annual global sales of Xolair® were approx. USD3.3Bn in 2020.

BiosanaPharma’s BP001 is one of the most advanced Xolair® biosimilar projects and is expected to start its Phase III in collaboration with Alvotech in 2023.

BiosanaPharma is the first company to have performed a Phase I study with a product made on a fully integrated (USP, DSP), continuous monoclonal antibody manufacturing platform. The “3C” continuous platform is able to deliver monoclonal antibodies at significantly higher yields, at a fraction of the current market production costs (up to 90% cheaper), representing a unique opportunity for biosimilar manufacturing and beyond.

Headquartered in Iceland, Alvotech is a leading pure play biosimilar platform focused on the global development and manufacture of high-quality biosimilars.

Alvotech’s pipeline contains eight biosimilar candidates covering autoimmune disorders, eye disorders, osteoporosis, and cancer with estimated cumulated peak originator sales of more than $80bn.

In December 2021, Alvotech announced that it had entered into a combination agreement with a SPAC sponsored by Oaktree Capital Management for a future listing on Nasdaq. The transaction will deliver $450m proceeds to Alvotech to accelerate its growth, valuing the company at $2.25bn