Alvotech

Tomaz Vaupotic is Head of Clinical and Medical Quality at Alvotech. With expertise in biomedical sciences, he leads quality oversight across clinical, medical, and pharmacovigilance functions, ensuring global regulatory compliance, inspection readiness, and evidence integrity for biologic therapies. Through this article, Vaupotic highlights a proactive, digitally driven approach to quality that balances regulatory compliance with innovation in biosimilar development.

My approach has always been proactive in preventing non-compliance and simplifying the design of all regulated activities, documents, processes, and systems to ensure their future state of compliance in a “natural” way of working with long-term impact. My team also endeavours to establish and nurture a quality culture among everyone in our clinical and medical teams by developing capabilities and competencies and radically broadening inspectional intelligence.

Navigating the Complexities of Global Harmonisation

Harmonising, or better said, integrating, the global regulatory requirements in clinical development, medical quality assurance and biosimilar innovation into internal procedures is a rather complex endeavour. It involves aligning diverse regulatory frameworks and scientific guidelines across countries and regions. The vast variety of inspectional expectations, which can vary from one inspector to another, also burdens developers due to over-proceduralizing just to pass inspections.

Balancing Innovation and Compliance in Biosimilar Development

In essence, medical innovation has always been based on balancing risks. We can see some well-accepted recent risk-proportionate advances in the thinking of major regulators, too, such as replacing redundant clinical trials with smarter science, like waiving confirmatory efficacy trials when robust data from pharmacokinetic and immunogenicity studies suffice, and shifting the safety net to post-approval pharmacovigilance. Of course, all of this is still underpinned by rigorous operational compliance requirements.

The vast variety of inspectional expectations, which can vary from one inspector to another, also burdens developers due to over-proceduralizing just to pass inspections.

Driving Clinical Quality through Digital and Data-Driven Oversight

Digital tools and data-driven strategies have always been at the heart of our key clinical quality decisions, including supporting proactive quality interventions. I am very fortunate that Alvotech has a well-evolved digital acumen. My team is also very much in favour of all digital initiatives and data analytics, and we all look forward to seeing how AI-driven analytics will eventually drive data and process quality or proactively detect suspected serious noncompliance at the source of clinical and medical evidence generation.

The Future of Biosimilar Quality Leadership

I count on better harmonisation of all major competent authorities’ study design expectations for biosimilarity, reliance on and mutual acceptance of GCP, PV or BIMO inspectional results, data interoperability, harmonising various reporting timelines, and defragmentation of global pharmacovigilance systems. This would significantly contribute to sustainable growth in biosimilars' clinical and medical evidence generation.

Quality leaders should not be shy about undertaking more unconventional approaches in quality management and quality decisions. Overthinking or over-interpreting of regulatory requirements and over-imposing guidelines as ultimate rules can lead to duplicative efforts, delayed approvals, and increased trial costs while not necessarily contributing to better scientific validity of clinical and medical evidence, nor better safety of trial participants or patients. The key is to infuse quality-wise thinking and behaviours in a way that does not even feel like the “boring” quality, but instead empowers all individuals in the organisation to make risk-balanced, educated, and compliant decisions. For example, have you ever thought about why in so many organisations mass emails get sent to all of those who have late quality deviations or actions, but you would rarely see organisations sending mass appreciation to those who had completed their quality deviations and actions promptly, and could be a role model for others?

Organisations should involve quality leaders early in development to shape trial design, excellence, and risk mitigation strategies. We all co-create access to medicines! Likewise, the quality leaders should refrain from insisting on the so called “quality image from the ‘90s”, but instead break silos by integrating with clinical and medical teams. Replacing rigid procedures with adaptive frameworks that evolve with science and regulation, using predictive quality intelligence, and upskilling teams in data science instead of over-reliance on reactive quality methodologies will be essential for driving smarter and faster quality decisions. We can only stay at the forefront of our competitors if we are better, leaner and faster in our decision-making! Because we all need to eventually pass regulatory inspections for approvals, which are prerequisites for enabling better access to medicines, especially in underserved patient populations.