Innovation can happen anywhere – and we are seeing an increasing number of novel medical solutions originating from outside the US. Each company aims to gain traction in the United States, where there are immense opportunities for growth, investment, and access to a vast, innovative ecosystem. However, the complexities of the US biopharma landscape are defined by regulatory hurdles, stiff competition, and distinct market dynamics. For foreign companies, a strategic and informed approach to entering the US is critical for success. 

At TellMed, our experience includes supporting the US arms of two European-led big pharma companies, providing guidance for an FDA committee hearing and launch planning for the first ex-US company to gain a biosimilar approval in the US, and helping an Australian brain-computer interface company establish roots here, among other examples. Here are some considerations for companies making the leap to the US. 

• It’s not just FDA regulations to consider. When communicating on social media and engaging media and spokespeople, it’s important to understand the US regulations, both legally and ethically, including government entities and PhRMA guidelines. Recognizing the stringent rules governing the communication of scientific information, and knowing the best ways to adhere to them, is the cornerstone of all US communications. 

• Cultural differences extend beyond meetings and influence how companies engage with journalists, third parties, and on social media. In Europe, many journalists are paid by companies to attend medical meetings, so European companies initiating efforts in the US may not immediately understand the value of news organizations as independent third parties, or the importance of taking the time to engage US journalists appropriately for our culture. Another example is in patient advocacy, a critical consideration in every US communications strategy. Unlike in many other markets, U.S. patient groups often have a seat at the table on trial design, and FDA advisory committees increasingly consider patient perspectives when evaluating therapies and deciding whether or not to approve a treatment.

• It’s not just about translating the words, but communications also requires understanding the context, tone, and personal connections. In our work with companies from Scandinavian countries, developing messaging has sometimes been a challenge because they were hesitant to write about their strengths, viewing such statements as bragging. Conversely, we’ve also worked with companies from other countries that encourage bold self-promotion and downplay negative product attributes, which must be toned down to comply with US regulations and cultural US norms related to transparency and authenticity. While AI can help translate words, generate ideas and accelerate execution, successful communications programs require human insight, strategic judgement, and relationship-building.

• Competition can be fierce. The US biotech sector faces a challenging funding environment that requires companies to differentiate themselves and strategically engage investors. Creating visibility requires companies to define what makes them different within the context of the broader U.S. biotech and pharmaceutical ecosystem. Communicating those distinctions must be done in ways that resonate with key audiences, and create branding and messaging that align with the culture, the ecosystem and regulatory parameters. This includes tailoring messaging to specific stakeholder needs, simplifying scientific jargon, and emphasizing key milestones and achievements. 

Successfully navigating the communications landscape when establishing a US biotech subsidiary requires a multi-faceted approach that addresses regulatory compliance, balances scientific credibility and authentic human connection, fosters effective internal and external communication, and adapts to the unique demands of the US markets.