European market-entry strategy for biopharma companies

The European pharmaceutical market offers many opportunities for U.S. biopharmaceutical companies. An early engagement as well as a visceral understanding of the heterogeneity of the European market are key to succeed. Partnering with a Swiss-based, commercial-stage pharmaceutical company offers various advantages. Because of its diversity and non-bureaucratic access to a talented workforce, Switzerland is an ideal location to kick off your international go-to-market strategy.

Often the initial development strategy of emerging U.S. biopharmaceutical companies with one or a few pipeline assets is focused on the U.S. pharmaceutical market. The U.S. represents the largest pharmaceutical market worldwide. Company executives are well familiar with their ‘home’ market and the geographical proximity helps to assess the regulatory, scientific, clinical and market access framework to develop a successful go-to-market strategy.

Diverse European market

In nowadays global pharmaceutical market an initial sole U.S. focus can be sub-optimal and may limit the ability to fully harness the potential of drugs in markets outside of the U.S. With its 28 member states, the European marketplace is not only a large developed pharmaceutical market, but also presents a variety of challenges: from numerous working languages to a complex heterogeneous regulatory, healthcare system and market access framework.

In Europe, healthcare systems regulation lies exclusively within the authority of each country. There is little or no convergence of European health policies. On the contrary, healthcare systems are nationally under constant (cost) pressure to reform to meet the increased demand for improved care as well as the challenges coming from the population ageing.

To launch a new drug and obtain appropriate market access, biopharmaceutical companies face in Europe a far more complex and costly market entry procedure than in the U.S. Each nation in the European Union (EU) applies different criteria, which include therapeutic and economic parameters. And each European country operates at its speed. A thorough understanding of these criteria (such as requested comparators, patient reported health outcomes, etc.) and their consideration in the ongoing clinical development program is crucial.

Early stakeholder engagement

An early engagement with the medical community as well as with patient support groups to understand the treatment paradigm, diagnosis and referral patterns in Europe is a further must. These learnings need to be incorporated in the late development program and considered when designing a supportive advocacy strategy.

An early engagement with EU regulatory authorities is also recommended to ensure that the development program meets the combined needs of both the U.S. and the European regions. Further, different filing routes—centralized and decentralized—and the various options need to be considered depending on the type of product and therapeutic indication. Also from an operations and quality perspective, the EU market poses challenges to new entrants. All products manufactured outside of Europe Union must undergo EU import testing according to Directive 2001/83/EC and be QP released in the EU market.

From a brand management perspective, one of the biggest practical challenges to entering the European market is the multitude of languages, resulting in a large number of associated country-specific pack formats and artworks.

Switzerland – the ideal international spring board

Switzerland is not only a key test market in Europe for ex-EU companies, but also considered to be a key location for international headquarters, particularly by biopharmaceutical companies. The U.S. department of trade’s Country Commercial Guide (CCG), for example, cites Switzerland’s highly developed, multilingual market, its location in the middle of Europe, and its well-educated and affluent population. Additionally, Switzerland offers a stable and business-friendly environment with attractive financial and fiscal frameworks. The Greater Zurich Area has made itself a name as hub for biopharmaceutical in Europe. First-class universities and research institutions have contributed to the establishment of international companies such as Biogen, Amgen, Shire, Alexion, Alnylam and Cardinal Health in the past.

In summary, launch excellence is rooted in the ability to understand and react to launch drivers in the marketplace, which in Europe likely differ from country to country. The collaboration with a strategic Swiss-based biopharmaceutical partner with proximity and good understanding of the EU market offers a number of advantages.

About the author

Lorenzo Bosisio has been Chief Executive Officer of EffRx Pharmaceuticals SA since 2016. Prior to that, he served as the company’s Chief Commercial Officer. During his tenure with EffRx, he has built the commercial infrastructure and successfully recovered and re-launched the company’s lead product. Lorenzo has driven EffRx’s transformation from a drug development company to an integrated biopharmaceutical company with an international footprint. Lorenzo has significant strategic and operational leadership experience from senior positions at Amgen, Alexion, PwC, and Tissot Medical.

EffRx Pharmaceuticals SA is a commercial-stage pharmaceutical company, which focuses on developing and commercializing prescription medications for specialty and orphan indications. EffRx actively seeks collaboration opportunities with U.S. bio-pharmaceutical companies, which are looking to commercialize their products in Europe. EffRx can act as accelerator of EU go-to-market strategies and be a spring board for an initial international set-up in Switzerland.