One of Greece’s leading domestic pharmaceutical companies, RAFARM has had a stellar recent history, including a momentous entry into the US market. Now looking to establish itself as one of Europe’s major players in ophthalmics and complex injectables, VP Aris Mitsopoulos highlights the key learnings from this US experience and his ambitious growth plan for the firm.
Mitsopoulos – an 18-year RAFARM veteran – lays out the company’s historic last half-decade thusly. “Over the last five years, driven by innovation and growing dynamically, RAFARM has continually invested in expanding both its expertise and international footprint. Our exports, which have doubled since 2017, today represent over 75 percent of our production.”
Despite the lingering challenges of both the financial crisis years as well as the COVID-19 pandemic, RAFARM secured a massive 63 percent increase in its consolidated turnover between 2017-2021, a 15 percent growth in turnover and 40 percent growth in exports from 2020 to 2021, doubled its headcount, and reinforced its position in the European market. “We own more than 1,200 approved licenses worldwide and export to more than 60 countries across five continents,” adds Mitsopoulos.
Our exports, which have doubled since 2017, today represent over 75 percent of our production
Aris Mitsopoulos, RAFARM
The most significant achievement though was entry into the US market, the holy grail for most European pharma companies, but a major challenge in terms of scale and strategy. “The major milestone of recent years was RAFARM’s entrance into the US market, which required a great deal of effort and investment,” notes Mitsopoulos. “This has been a great success, with our production site having been FDA-approved since 2018 and the company already having six high-performing products in the US market. Moreover, we have ongoing development and registrations for a further 15 new ANDA filings.”
However, this US market entry was not all plain sailing. “At the beginning, it was challenging,” admits Mitsopoulos. “RAFARM has traditionally operated as a European company, primarily exporting to other countries within Europe, where we are used to the fragmentation of the markets, the demands of both customers and local authorities, the stock-keeping units (SKUs), and the intellectual property (IP) situation.”
He continues, “The USA offers great opportunities as the biggest market in the world, but competition is fierce, and the generic drug industry has been experiencing challenges with prices eroding rapidly, new competitors coming with low-price products, and pharmacies joining forces with wholesalers to leverage purchasing power. What we do to succeed is focus our efforts on being first-to-file and first-to-market, as well as offering value-added medicines and differentiated complex products. Additionally, we grow our necessary capabilities, including navigating PIV and 505(b)2 filings.”
Looking to the future, Mitsopoulos is extremely optimistic that the company’s US experience and approvals from the FDA – the global regulatory gold standard – will lead to more international markets unlocking. “This is already happening,” he proclaims. “For example, RAFARM has managed to achieve rapid approval for its products in Saudi Arabia, thanks to the mutual agreement in place, between the Saudi and US FDAs. The entry into these new markets not only affects our bottom line but also helps develop our internal capabilities in areas like production and operations.”
He concludes, “Following this, we have been able to look even further afield to even bigger, but even more challenging, markets. China, for instance, has long been one of the most demanding markets for European companies due to the country’s shifting regulatory requirements and the need to strike up joint ventures with local firms. After working for almost five years on two projects in China, we hope to launch our first products in the Chinese market in 2023, which will be another significant milestone for RAFARM.”