Vor 20 Jahren war die Biotechnologie-Landschaft in Deutschland noch deutlich überschaubarer und BIO Deutschland begann als kleine Organisation mit relativ wenigen Mitgliedern aus der klassischen roten Biotechnologie. Wie die Branche, hat sich auch der Verband seitdem stark entwickelt und diversifiziert. Auch Formycon als Biosimilar-Spezialist gehört dazu und leistet seinen Beitrag zu Know-how, Investitionen und Wachstum.

Die Biotechnologie in Deutschland steht heute vor drei großen Herausforderungen: einem hohen Innovationsdruck, steigenden Kosten im Gesundheitssystem und unzureichender Finanzierung der Entwicklung. Es gab in den letzten Jahren bedeutende technologische Durchbrüche und viele der heute kommerziell international erfolgreichen Produkte basieren auf deutscher Innovationskraft und Technologie.

Fortschritt, Innovationskraft und verbesserte Gesundheitsversorgung führen aber auch zu steigenden Kosten im Gesundheitssystem. Eine logische Antwort darauf sind Biosimilars, die wir bei Formycon entwickeln. Diese biopharmazeutischen Nachfolgeprodukte ermöglichen es, hochwirksame Behandlungen zu deutlich niedrigeren Kosten anzubieten, was sowohl den Patienten als auch den Gesundheitssystemen zugutekommt. Die Bedeutung von Biosimilars wächst rasant und wird in den nächsten Jahren immer entscheidender, um den Zugang zu wirksamen Therapien zu verbessern und diese bezahlbar zu machen.

Die Entwicklung von Biosimilars ist komplex und erfordert jahrelange Forschung sowie hohe Investitionen bis zu ihrer Zulassung. Eine große technische und analytische Kompetenz sowie wissenschaftliche und regulatorische Expertise sind notwendig, um diesen Prozess erfolgreich zu meistern. Trotz der hohen Entwicklungskosten profitieren Biosimilar-Entwickler nicht von Exklusivitätsrechten, was den Margendruck erhöht. Deshalb müssen diese Unternehmen besonders effizient arbeiten, um im direkten Wettbewerb bestehen zu können. In einem Umfeld, in dem es keinen Patentschutz gibt, zählt jeder Tag und jeder Euro.

Der Erfolg eines Biosimilar-Unternehmens und insbesondere von Formycon basiert auf einem erfahrenen Entwickler-Team und einer klaren strategischen Planung bei der Auswahl der Kandidaten. Die enge Abstimmung zwischen Forschung, Entwicklung, Regulatorik und Vermarktung ist entscheidend, um ein Biosimilar erfolgreich auf den Markt bringen zu können. Bei Formycon haben wir gezeigt, wie wichtig es ist, auf die richtige Kombination aus Know-how und Erfahrung zu setzen. Unser Team hat sich in den letzten fünf Jahren auf rund 240 Mitarbeitende verdoppelt und wir haben all unsere geplanten Meilensteine erreicht: darunter die Zulassung und erfolgreiche Markteinführung unseres ersten Biosimilars in globalen Schlüsselmärkten sowie Zulassungen der FDA und EC für weitere Biosimilars in diesem Jahr.

Für Formycon ist die Auswahl der Partner – vor allem in den Bereichen Herstellung und Vermarktung – in diesem intensiven Wettbewerbsumfeld extrem wichtig, um Marktanteile und Margen zu sichern und den Markt mit hochqualitativen Biosimilars zu durchdringen. Die erfolgreiche Vermarktung und daraus resultierende Produktumsätze sichern in den nächsten Jahren einen Teil der Investitionen in unsere vielversprechende und diverse Pipeline von Biosimilars der nächsten Generation, wie z. B. für die dieses Jahr gestartete Entwicklung von Pembrolizumab.

Unser Erfolg basiert auf einer Mischung aus wissenschaftlicher Expertise, Marktintelligenz, Agilität, Flexibilität und Kostensensitivität, um im hart umkämpften Biosimilar-Markt zu wachsen und langfristig zu bestehen. Dies gilt auch für die deutsche Biotechnologie-Branche, die einem starken internationalen Wettbewerb ausgesetzt ist. Umso wichtiger ist die Arbeit von BIO Deutschland, die Interessen zu bündeln und sich für besser Rahmenbedingungen sowie Unterstützung in Politik und Öffentlichkeit einzusetzen. Biotech ist Zukunftstechnologie, die auch in den nächsten 20 Jahren Innovationen vorantreiben wird, um die Herausforderungen der Gesundheitssysteme zu meistern.

Formycon is regarded as a “pure play” biosimilars company. What exactly does this mean?

Dr. Stefan Glombitza, Chief Executive Officer: „Formycon is a globally operating, independent specialist in the development of biosimilar drugs. We aim to firmly establish our company as leader in the growing biosimilars segment and partner of choice for the major pharmaceutical names with their strength and reach in sales and marketing. For us, being a “pure play” specialist means complete and absolute focus on our capabilities and excellence spanning all phases of biosimilars development, from the process of selecting biosimilar candidates all the way through to regulatory approval.“

Dr. Glombitza mentioned the economic importance of FYB206 to Formycon. What more can you tell us about this?

Dr. Andreas Seidl, Chief Scientific Officer: „With this entry into immuno-oncology, we are opening up an area of active ingredients with extraordinarily large market potential. The IARC⁷ expects that worldwide cancer cases will continue to increase sharply in the future. The demand for these modern therapies is immense – so there’s a good reason why so many biosimilars are being developed for cancer treatment.“

How can FYB206 help cancer patients?

Andreas Seidl: „With FYB206, or pembrolizumab, we are developing a candidate biosimilar that works by activating the body’s own immune response to fight the tumor. This is a highly promising approach for numerous cancer indications, notably including non-small cell lung cancer and melanoma, a particularly aggressive form of skin cancer. These are, in fact, the two specific indications for which we are currently conducting our clinical trials.“

Top-selling reference drugs generally mean a lot of potential competitors in the biosimilars market space. Where do you see Formycon in this competition?

Andreas Seidl: „The start of clinical trials is a good indicator for comparing our own development progress to that of our competitors. All in all, we can be very satisfied by this metric because it means that we are in the leading tier of biosimilar developers, particularly within the target markets of the United States and Europe.“

So both of these clinical trials are already in progress?

Andreas Seidl: „Yes, the two clinicals studies are being conducted in parallel across several centers in Eastern Europe and Southeast Asia. In mid-June, we launched the Dahlia phase I study, comparing the pharmacokinetics, safety and tolerability of FYB206 with the reference drug Keytruda®. Study participants are patients who have had a malignant melanoma surgically removed.

For the Lotus phase III study, we recruited patients with non-small cell lung cancer and began the actual clinical trials starting from the end of July. The Lotus study compares the safety and efficacy of FYB206 to its reference drug Keytruda®.

I know that a lot is also happening in the area of commercialization. What are Formycon’s current priorities?

Nicola Mikulcik, Chief Business Officer: „Our FYB201 product, the biosimilar to Lucentis®⁸, also known as ranibizumab, is already available in 19 countries worldwide. In the United States and various other markets, we are pleased with the very good market penetration we’ve already achieved, and we are clearly leading in ranibizumab biosimilars. And the market launches are continuing: Most recently, we were able to announce the launch in Saudi Arabia through our commercialization partner MS Pharma. Further approvals and product launches are planned through to 2026, with a particular regional focus on Middle Eastern and Latin American markets.“

How have the European markets been developing?

Nicola Mikulcik: „We are working hard to further expand our market share within Europe. The introduction of pre-filled syringes to complement the currently available vials will play a key role in these efforts. This more convenient dosage form should be available to doctors and eye clinics over the course of the coming year.“

FYB202 and FYB203 are both approaching the commercialization stage. What are the next steps as you prepare for market introduction?

Nicola Mikulcik: „In the case of FYB202, our candidate biosimilar to Stelara®, we’re focusing on the initial market launches together with our marketing partner Fresenius Kabi and working hard to ensure that the product is available in sufficient quantities starting with the United States and Europe.

For our second ophthalmology biosimilar, FYB203, our partner and license holder Klinge Biopharma has concluded an exclusive license and supply agreement with MS Pharma for marketing in the MENA region. MS Pharma is very well positioned throughout this region and has already been successfully introducing our FYB201 product in these markets.

As to the United States and Europe, we expect to conclude corresponding agreements with strong commercialization partners in the second half of the year.“

How is 2024 looking so far from a financial perspective?

Enno Spiller, Chief Financial Officer: „The entry of Gedeon Richter as a strategic investor at the start of the year was a major statement of confidence. For us, this was not only a big success as a transaction but also a validation of our growth path and remarkable achievements over the past few years.
The cash inflow from this transaction of roughly € 83 million has made a significant contribution to our capacity to continue pushing forward with our biosimilar development projects, particularly FYB206, at a consistently rapid pace while also ensuring the highest quality standards.“

In the case of two biosimilar candidates, development is almost complete. What are your expectations for FYB202 and FYB203?

Enno Spillner: „As of now, we are fully on schedule with all of our development projects and are looking forward to the launch of FYB202, our candidate biosimilar to Stelara®, in 2025. Once the global market launch by our commercialization partner Fresenius Kabi is complete, FYB202 will significantly increase Formycon’s sales revenue and help us attain sustainable EBITDA profitability over the medium term. The settlement agreements with Johnson & Johnson have paved the way not only for the U.S. market but also, more recently, for the European and Canadian markets.

We cannot currently give a specific launch date for FYB203, as no agreement has yet been reached with Regeneron, the manufacturer of the reference drug.“

You’ve just issuance an upward revision to your guidance for fiscal year 2024. This is certainly a very positive signal. What were the triggers?

Enno Spillner: „Our current 2024 operating figures are looking good, and everything is going according to plan. Sales and EBITDA are expected to remain within the forecast range. We were pleased to be able to announce a significant upward adjustment to our Adjusted EBITDA forecast due to better-than-expected results from sales of FYB201, which are reported through our investment participation in the Bioeq AG joint venture. These ongoing earnings will make a sustained contribution to our company’s success.“

In summary, it’s clear from everything you’ve said that the first half of 2024 was very successful. Would you say that the path to future success is also clear?

Dr. Stefan Glombitza: „Our path to becoming a globally leading, independent, pure-play biosimilars specialist is supported by a deep personal commitment from the entire #TeamFormycon. This extends to the members of the Supervisory Board with their extensive industry experience not only in Germany but internationally.

On this subject, I would like to once again extend our deepest gratitude to Dr. Olaf Stiller and Peter Wendeln, the two Supervisory Board members who stepped down in June after having done so much to help us to reach where we are today. With remaining members Wolfgang Essler and Klaus Röhrig as well as newly elected members Dr. Bodo Coldewey and Nick Haggar, along with Colin Bond starting from October 2024, we aim to continue Formycon’s successful path but with an increasingly international orientation.

On behalf of the Executive Board, I would like to specially thank our employees. Without the extraordinary efforts of the entire team, the many remarkable successes achieved during the first half of 2024 would not have been possible. We are also grateful to our shareholders for their continued confidence in Formycon and in the work that we do.“

Thank you for taking the time to speak with us!