Alvotech (NASDAQ: ALVO) and STADA Forge Strategic Alliance to Expand Access to Biosimilars

Alvotech (NASDAQ: ALVO) and STADA, two prominent players in the pharmaceutical industry, have announced the extension of their strategic alliance, aiming to bolster access to high-quality and cost-effective biosimilars. The latest development sees the partnership encompass AVT03, a clinical-stage biosimilar candidate referencing the acclaimed Prolia®/Xgeva® (denosumab) medications, known for their efficacy in addressing osteoporosis and cancer-related bone loss.

The terms of the agreement outline Alvotech's pivotal role in the development and manufacturing of AVT03 at its cutting-edge facility in Reykjavik, Iceland. Upon approval, STADA will assume the mantle of marketing authorization holder and will wield semi-exclusive commercial rights across Europe, including Switzerland and the UK, along with exclusive commercial rights in selected countries in Central Asia and the Middle East.

This expansion of their collaboration is not confined to AVT03 alone; it extends to include STADA's commercial rights to biosimilars for Humira® (adalimumab) and Stelara® (ustekinumab) in the Commonwealth of Independent States (CIS) countries in Central Asia. Additionally, Alvotech will regain commercial rights to AVT06, a proposed biosimilar to Eylea® (aflibercept), underscoring the dynamic nature of their partnership.

Bryan Kim, STADA's Global Specialty Head, expressed optimism about the alliance, stating, "STADA sees a major opportunity to offer patients and clinicians a further treatment with denosumab." He highlighted STADA's commitment to enhancing patient care and leveraging its expertise in the pharmaceutical domain to address unmet medical needs effectively.

Anil Okay, Chief Commercial Officer of Alvotech, echoed Kim's sentiments, emphasizing their shared goal of improving patient access to affordable biologics. He underscored the significance of the expanded alliance in driving innovation and advancing biosimilar development, leveraging Alvotech's robust capabilities and expertise in the field.

Denosumab, the focal point of their collaboration, holds immense promise in addressing bone-related disorders. As a human monoclonal IgG2 antibody targeting the protein RANKL, denosumab plays a crucial role in mitigating osteoclast activity, thereby preventing bone resorption and combating cancer-induced bone destruction. The potential impact of biosimilars like AVT03 in expanding treatment options and reducing healthcare costs cannot be overstated, particularly in light of the significant burden posed by osteoporosis in Europe.

According to estimates, approximately 32 million Europeans aged 50 years and older grapple with osteoporosis, with women constituting a majority of sufferers. The economic toll of osteoporotic fractures underscores the urgency of expanding access to effective treatments, with the total direct cost in 2019 amounting to a staggering €56.9 billion (USD 61.9 billion) across select European countries.

As Alvotech and STADA forge ahead with their strategic alliance, their concerted efforts to democratize access to biosimilars hold the promise of transforming healthcare delivery. By combining innovation with a patient-centric approach, they are poised to make significant strides in addressing the unmet needs of millions grappling with debilitating bone-related conditions, ushering in a new era of affordability, accessibility, and efficacy in biologic therapies.