Lessons Learned from Successful Biopharma Launches in Europe
Never underestimate it - successfully launching a new medicine into major European markets is a complex and highly fragmented process that requires deep strategic planning and flawless execution.
Success hinges on early engagement with regulators, clinical stakeholders, and market access bodies to ensure that the chain of stakeholders is unlocked sequentially using the right data and arguments.
A few weeks ago, we asked senior members of the LUCENT team about their key recommendations for achieving this in Europe. We wanted this to be based on experience and data, but just as importantly driven by their instincts born out of the dozens of new medicine launches undertaken by the team over the past decade.
1) “Include EU-Relevant Clinical and Payor Endpoints to Phase 3 Study Protocol Design”
European regulators and HTA bodies prioritise specific clinical endpoints when evaluating new medicines. These are more-often-than-not different than those for the US.
Even if there is no strategic commitment to launching in Europe, early alignment with EU regulatory and reimbursement requirements ensures that pivotal studies capture relevant outcomes, reducing the risk of approval delays or negative reimbursement decisions.
Engaging with EU clinical experts, the European Medicines Agency (EMA), as well as national agencies such as the National Institute for Health and Care Excellence (NICE) in the UK helps to define endpoints. This reflects both clinical and real-world effectiveness in Europe and could save having to add to your Phase 3 burden in the future.
This consideration extends to study design considerations such as standard-of-care and inclusion/exclusion criteria.
2) “Ensure EU Clinical Study Sites Are Included in the Phase 3 Plans – Even If Just One Per Country”
Adding a handful of European clinical sites into Phase 3 trials and following the EMA’s clinical trials guidelines provides multiple advantages:
Firstly, it facilitates familiarity with the medicine among European investigators, who can later serve as subject-matter experts to support regulatory submissions and market access engagements.
Secondly, it allows for the collection of region-specific clinical data, which will be critically valuable for both regulators and payers.
Lastly, conducting trials within the EU strengthens engagement with local healthcare professionals, ensuring early buy-in and smoother post-approval adoption.
A softer, but no less important consideration is that this gives the company a compelling reason for making an early physical entry to the key EU countries.
3) “Place At Least One MSL into Each Major EU Market Around the Time You Start Phase 3 Recruitment”
Establishing a physical presence in key EU markets during Phase 3 fosters early engagement with healthcare professionals, patient groups, reimbursement authorities and regulatory bodies.
The best first-hire here is a single medical science liaison (MSL) for each EU country, co-ordinated by a central MSL manager or player-manager.
The list of benefits of even a single MSL in a country is endless, but includes:
Clinical trial site set-up support and trouble-shooting
Company representation at trial sites (assuming the study is being operationalised by a CRO)
Scientific support and education to investigators and trial sites
Awareness of the new medicine's clinical potential to clinicians and prescribers
Provide reactive Medical Information resource across the country that they are based-in
Act as the eyes-and-ears on the ground in their country
Start launch planning and the transition to promotion as the regulatory approval approaches
Early engagement with Regulators and Payors (see number 4 below)
Having dedicated MSLs in markets such as Germany, France, the UK, Italy, and Spain enables companies to address local scientific queries and build relationships that will be crucial for launch success and inflect the uptake of the new medicine for years to come.
4) “Use (2) and (3) Above as Your Platform to Engage Early with Clinicians, Regulators and Reimbursement Bodies in Each of the Major EU Markets”
The data from EU-based clinical sites and the presence of MSLs serve as critical assets in discussions with clinicians/prescribers, regulators and payers.
MSLs can provide medical and scientific insights that support discussions on value demonstration, while European clinical site data strengthens the case for reimbursement. By proactively engaging these stakeholders, companies can optimise their clinical, regulatory and market access strategy.
5) “Limit Risk to the Business by Hiring (ad-interim) a Specialised EU Launch MSL Team Until Phase 3 Data Is Available and the EU/UK Regulatory Dossier Is Submitted”
Given the uncertainties surrounding Phase 3 data, regulatory approvals and country-level market access decisions, a stage-gated hiring strategy, based around milestones and risk inflection points is key.
Employing a specialist EU MSL team mitigates this risk whilst accessing the key benefits to the company discussed above.
Once Phase 3 data is available and the regulatory submission is in progress, the MSL team can transition to permanent roles. At this stage, it is appropriate to establish a formal EU presence by hiring a country General Manager and Medical Director in each key market to lead launch preparation efforts.
Watch-out though… This specialist EU MSL team is not the same thing as a contract field-force (that is not specifically experienced in the needs of pre-launch planning and the transition from Phase 3 into filing and then launch prep).
Choose this team with care and ensure that:
They are proven experts in delivering on this very specific need.
You have great flexibility in the engagement – allowing withdrawal from the commitment based on precipitation of risk in any/all of the EU markets. Typically a three-month get-out is desirable here.
Key Takeaways
A successful European launch requires meticulous planning and early stakeholder engagement. Aligning clinical trial design with EU regulatory and payer expectations, strategically placing MSLs in key markets, and maintaining flexibility in the initial resource deployment all contribute to a smooth and effective market entry, at minimal risk.
By following these recommendations, companies can optimise their EU launch trajectory, ensure regulatory success and rapid adoption of their new medicine across Europe, all-the-while giving themselves a high degree of control and strategic flexibility in their commitment to the region.
We recommend partnering with biopharma experts that are well-versed in navigating European regulatory and reimbursement landscapes. At LUCENT, we have well-established relationships with key stakeholders across the EU, UK and US, built over decades of working in the industry. Our proven ability to align R&D efforts with marketing requirements is invaluable to any business looking to launch a new treatment into the EU marketplace.
Whether you’re a smaller biotech looking to gain a foothold in the region, or a well-established pharmaceutical organisation looking for some expert guidance to augment your team’s skillset, don’t hesitate to get in touch with our specialists today for a no-obligation chat about your requirements.
Get in touch
Related Articles
