Helping European Drug Development Companies Succeed in the US Market

The United States remains the largest and most profitable market for medicines globally, with a staggering 49 percent of the world’s pharmaceutical sales (source). As of 2024, the US pharmaceutical market was around $640 billion and growing at more than 6 percent per year [1]. However, the myriad of rules, regulations, and opportunities make the development and approval of drugs in the US both complex and daunting.

European drug companies who are looking to obtain approval in the lucrative US market benefit from experts who can help them navigate the fastest path to the broadest possible market opportunity. This article explores how MMS supports European companies in navigating these hurdles and achieving success in the US market.

The FDA also has specific requirements around study populations, such as representative patient diversity. Additionally, the FDA differs from its European counterparts in the structure of its dossiers, review processes, and norms and standards.

We expect the complexity to increase, not decrease, over time. This means that continual monitoring of the evolving drug development landscape is crucial to ensure that advice remains current. It is equally important to note that organizations often underestimate the time, cost, and expertise needed to navigate US regulatory requirements effectively.

The FDA is known as the gold standard for drug approvals, and an approval with the FDA can help secure global approvals through the right preparation.

The Role of MMS as your partner

MMS, a leading global data-focused Clinical Research Organization (CRO), offers a comprehensive suite of services tailored to support European drug development companies in their US development and approval efforts.

Here are some keyways that MMS can help:

1. Partnering to optimize your design: MMS Regulatory and Statistical experts can support you in optimizing the design of your program and its component clinical trials. There are often faster, less expensive design options, including fewer patients, different endpoints, and potentially augmenting prospective data with Real World Data (RWD). MMS can bring the statistical expertise to define these opportunities, combined with the strategic regulatory capabilities to assess their acceptability to FDA.
2. Regulatory Submissions Support: MMS provides expert guidance on regulatory submissions, from INDs to NDAs or BLAs. MMS teams are well-versed in identifying opportunities to access accelerated pathways to approval and can advise on risks and benefits associated with each possible course of action. MMS has delivered NDA and BLA submissions via all novel pathways in the US and has supported multiple first-in-class submissions, as well as those in unique and rare indications. Additionally, MMS can draft justifications for not requiring a post-approval REMS or proactively assist in REMS design. Our team of regulatory experts ensures that your drug development process is compliant with FDA requirements and strategically aligned with global health authority standards.
3. Clinical Trial Management: MMS offers clinical trial management services, including compliance and auditing, as well as full-service biometrics (Data Management, Programming, Statistics, and Data Science). Our Datacise® platform supports real-time data status and emerging trends, helping to accelerate and de-risk trials.
4. Safety and Pharmacovigilance: The US has specific requirements for safety during clinical development and through submission and beyond. Not least, the potential for REMS in certain disease settings and drug classes. In addition to comprehensive traditional pharmacovigilance, MMS can design, source and implement Independent Data Monitoring Committees (IDMCs) or Data Safety Monitoring Boards (DSMBs) on studies, including programming and reporting through Datacise. We also deliver full-service REMS solutions, including design and implementation.
5. Global Reach and 24/7 Support: With a global team of experts available around the clock, MMS ensures that your programs receive continuous support and quick mobilization. This international presence allows for seamless collaboration and scalability of solutions to meet your needs.
   
   Developing drugs and seeking marketing authorization in the US is a significant step for a European drug development company, particularly smaller biotech organizations. However, taking this step doesn’t need to be a daunting one. With the right partner, such as MMS, companies can navigate the regulatory landscape, manage clinical trials efficiently, and ensure patient safety. By leveraging MMS expertise and comprehensive solutions, European companies can successfully bring their innovative treatments to the US market and positively impact patient lives.

To discuss how we can enable your success in the US market, email info@mmsholdings.com.