IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars and Generics

Experts from IQVIA and the broader pharmaceutical industry gathered to discuss critical aspects of the regulatory landscape for lower-cost products during a recent webinar titled “Expanding Horizons: Regulatory Strategies for Biosimilars and Generics for Global Success.”

The Hatch-Waxman Act of 1984, which established a legal framework for generics in the US, emphasizing the importance of bioequivalence for generic approval. In 2010, the Biologics Price Competition and Innovation Act was passed and paved the way for a regulatory approval pathway for biosimilars. | Image credit: Inna Dodor - stock.adobe.com

Keith McDonald, senior director of regulatory affairs, clinical operations at IQVIA, kicked off the discussion with an exploration of global development strategies for generics and biosimilars, offering insights from both the US and European perspectives. McDonald discussed the Hatch-Waxman Act of 1984, which established a legal framework for generics in the US, emphasizing the importance of bioequivalence for generic approval. He outlined key components required in regulatory dossiers, particularly focusing on the chemistry, manufacturing, and control (CMC) data essential for the approval process.

Transitioning to biosimilars, McDonald provided an in-depth look at their regulatory pathways in both the US and European Union (EU), referencing the Biologics Price Competition and Innovation Act of 2010. He addressed the skepticism that biosimilars initially faced and the ongoing efforts to build confidence in their use. The challenges surrounding biosimilar development were also highlighted, alongside the importance of clinical studies in demonstrating their safety and efficacy.

McDonald also discussed UK-specific regulatory considerations in the wake of Brexit, the colloquial name to describe the UK leaving the EU. As the UK develops its post-EU regulatory identity, he highlighted the country’s approach to biosimilars, emphasizing analytical characterization and pharmacokinetic and pharmacodynamic data to support approval rather than data from comparative efficacy studies. The possibility of parallel or advance approvals in the UK was raised as a way to streamline biosimilar entry into the market.

Ankit Tyagi, associate director of regulatory affairs at IQVIA, took the stage next, focusing on the operational aspects of expanding into emerging markets. Tyagi highlighted the vast opportunities these markets present, while also stressing the importance of having a thorough understanding of local market dynamics and regulatory requirements.

Tyagi walked through the different approval pathways available in emerging markets, such as mutual recognition and expedited review pathways. He emphasized the critical need for local manufacturing and compliance with country-specific CMC and Good Manufacturing Practice (GMP) requirements. His key takeaway was the necessity of a robust regulatory strategy to successfully navigate the complexities of expanding into these regions.

"A regulatory strategy is not only about selecting the right pathway like [biologics license application or new drug application] for drug approval, it is more towards a comprehensive understanding of the drug development process for state adoption, to the dynamic regulatory environment, knowledge about the local market and availability to leverage regulatory requirements in a way that it can provide a competitive advantage,” he explained.

In addition to approval strategies, Tyagi emphasized the importance of post-approval maintenance. This includes managing change control assessments, planning for renewals, and considering withdrawal strategies. He discussed how local regulatory authorities play a crucial role in ensuring long-term supply chain continuity and compliance in these markets.

Amar Tandon, associate director of regulatory affairs at IQVIA, followed with a discussion on submission strategies and the critical role technology plays in this process. Tandon highlighted the importance of regulatory intelligence for understanding and anticipating local requirements, which can lead to greater efficiency in submissions. He underscored the need for a strong regulatory information management database to support these efforts and ensure that each country’s unique regulatory needs are met.

Chikkam Rama Mohan Rao, senior director of regulatory affairs at IQVIA, provided insights into how digital tools can improve submission efficiency. He highlighted the importance of automation, document management systems, and data integration to ensure the quality and timeliness of approval submissions. Rao emphasized the benefits of electronic submissions and how regulatory intelligence systems can help streamline the process and improve outcomes.

Praveen Reddy, PhD, DVM, DABT, deputy general manager at Lupin Biotech, closed the panel with a discussion on the variations in regulatory requirements across different regions, which can present challenges in dossier submissions. He highlighted the importance of having internal knowledge and strong technological systems to classify and manage these variations effectively. Pillay stressed the need for clear communication and collaboration between sponsors and regulatory agencies to ensure smooth submissions.

The webinar wrapped up with McDonald discussing future trends in the regulatory landscape. He pointed to increasing global alignment among regulatory authorities and the growing importance of international collaboration. McDonald also touched on the role that innovative clinical trial designs and new technologies will play in the future, predicting faster approval processes as a result of these advancements.

McDonald emphasized, “I think there has been, and there continues to be, more global alignment across regulatory authorities…. We can look at the challenging and clinical development of new products, we can think about the increased personalization of new medicines so those new treatments will challenge our expectations on data requirements to demonstrate safety and efficacy. New technologies coming forward will present challenges for regulatory authorities, where the regulatory frameworks have perhaps not considered that type of product previously, and that is where international collaboration can help to drive those standards.”

Reference

Expanding horizons: regulatory strategies for biosimilars and generics for global success. IQVIA. September 16, 2024. Accessed October 9, 2024.https://www.iqvia.com/events/2024/08/expanding-horizons-regulatory-strategies-for-biosimilars-and-generics-for-global-success