Blog

With numerous approvals, new commercialization partnerships, and product launches in various regions of the world, Formycon achieved important milestones in the first half of the year and consistently advanced its corporate development. We expect further significant operational and commercial progress in the coming months.

Although structural challenges regarding access to biosimilars continue to exist in specific markets, the global biosimilar business continues to grow dynamically and offers tremendous potential: for better patient care worldwide, for relieving the burden on healthcare systems, and for a company highly specialized in biosimilars such as Formycon.

At the mwb Research Roundtable, Dr. Stefan Glombitza (CEO), Enno Spillner (CFO), and Dr. Andreas Seidl (CSO) discuss these developments and answer participants’ questions. The Roundtable is in German.

Strategic partnerships between biotech companies and large pharma players have become a cornerstone of innovation and market access. Biotech companies like Formycon, which specialize in biosimilars (biological medicines that are highly similar to already-approved medicines), rely on these alliances to efficiently bring their products to market. For instance, through partnerships with Fresenius Kabi, Sandoz and Teva, Formycon has successfully advanced the commercialization of several biosimilars. These collaborations underscore a broader industry trend: success in biotech is driven not only by scientific innovation but also by the ability to forge strong alliances that enable commercial access and scalability as well as mitigating financial risks. In an industry where regulatory approval processes and market access are highly complex, partnershipsbbetween small biotech firms and large pharma companies are essential for long-term sustainable growth.

“Biosimilars may be approved without providing CES (Comparative Clinical Efficacy Studies) or even PD data (Pharmacodynamic) if similar clinical efficacy and safety pharmacology can be inferred from a sufficiently stringent evaluation of analytical comparability, in vitro pharmacology, and a comparative clinical PK (Pharmacokinetic) trial”, is the conclusion of the “Reflection paper on a tailored clinical approach in biosimilar development” the EMA has just released for public consultation.

We at Formycon clearly welcome this approach, as it has the potential to accelerate biosimilar development and reduce costs significantly. In the long term, this could also reduce the often-described biosimilar void (the number of off-patent biologics without biosimilar competition) and improve patient access to biologic therapies. With regard to our decision to discontinue the Phase III trial of our biosimilar candidate FYB206 we see the reflection paper as confirmation. We believe that the EMA’s considerations support our approach of demonstrating the therapeutic comparability of FYB206 with the reference drug Keytruda® based on comprehensive analytical data and the data from the Phase I study (Dahlia PK study).

According to the EMA draft, in terms of clinical development, PK studies (Phase-I-Studies) are in general sufficient for the approval of a biosimilar. CES studies (Phase-III-Studies) may still be required in cases where a “biological is not well-characterisable and/or has an unknown or poorly understood Mode of Action, structure-function relationship, or if the impact of observed differences on clinical outcomes is unclear”. To address any remaining uncertainty regarding comparability in exposure, safety and immunogenicity, the comparative PK study will be adapted in the reflected tailored clinical approach.

The published draft can be reviewed and commented on during the public consultation period until the end of September 2025: https://www.ema.europa.eu/en/documents/other/reflection-paper-tailored-clinical-approach-biosimilar-development_en.pdf

In a video interview with Andreas Schmidt from Schutzgemeinschaft der Kapitalanleger e.V. (SdK), Enno Spillner explains why Formycon can waive the phase III trial for the pembrolizumab biosimilar candidate FYB206. He also addresses the current dynamics on the US biosimilar market, which have led to reduced sales expectations for the ustekinumab biosimilar FYB202 and the temporary pause in the commercialization of the ranibizumab biosimilar FYB201 in the U.S.

The interview is held in German.

The Management Board of Formycon AG presented recent developments in various biosimilar projects in a webcast. The replay of the webcast can be accessed via the following link: Formycon Update February 2025.

https://research-hub.de/companies/formycon-ag