FYB206 (pembrolizumab biosimilar) / Formycon, MS Pharma - LARVOL DELTA

Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206, a biosimilar to Keytruda (Pembrolizumab), in the U.S. and Canada (The Manila Times) - "Under the terms of this agreement, Formycon AG will finalize development, prepare and file the regulatory dossier, and supply the product, while Zydus will be responsible for the commercialization of FYB206 in the U.S. and Canada....Upon signature of the agreement, Formycon will be eligible to receive mid-teens-million-euro upfront and milestone payments in 2025. In addition, Formycon will be eligible for further payments linked to the achievement of defined development and regulatory milestones, which in total are expected to amount to a mid-double-digit-million-euro range."

Licensing / partnership • Hematological Malignancies • Solid Tumor

…progress with the pembrolizumab biosimilar candidate FYB206. (Formycon Press Release) - "Patient recruitment for this ongoing Phase I PK study was already completed in July. Formycon expects results for the primary endpoint in the first quarter of 2026."

P1 data • Melanoma

Formycon AG…and MS Pharma jointly announce that they have entered into an exclusive licensing and supply agreement for the commercialization of FYB206, Formycon’s biosimilar candidate to the blockbuster drug Keytruda (pembrolizumab), in the Middle East and North Africa ('MENA region') (Formycon Press Release) - "The agreement includes an option for future technology transfer....Upon signature of the agreement, Formycon will receive an upfront remuneration and will be eligible for further payments contingent on the achievement of certain development and regulatory milestones, which are expected to total up to the high single-digit million Euro range. Formycon will further receive a significant share of the gross profits generated in the region."

Licensing / partnership • Hematological Malignancies • Solid Tumor

Dahlia: Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients (clinicaltrials.gov) - P1 | N=94 | Active, not recruiting | Sponsor: Formycon AG | Recruiting ➔ Active, not recruiting

Enrollment closed • Melanoma • Oncology • Solid Tumor

Formycon successfully completes patient enrollment for the clinical development of its Keytruda biosimilar candidate FYB206 (Formycon Press Release) - "Following the successful completion of clinical development and approval by the regulatory authorities, Formycon currently expects the earliest market entry of its biosimilar candidate FYB206 after the expiry of the market exclusivity of the reference product in 2029 for the USA and after 2030 for the EU."

Commercial • Melanoma • Non Small Cell Lung Cancer

Formycon successfully completes patient enrollment for the clinical development of its Keytruda® biosimilar candidate FYB206 (Formycon Press Release) - "Formycon AG...announced...that the patient enrollment for the clinical PK study Dahlia has been successfully completed with a total of 96 participants (Last Patient-In)...At the end of 2024, Formycon submitted a streamlined clinical strategy to the U.S. Food and Drug Administration (FDA) with the intention to demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda based on comprehensive analytical data and data from the PK study (Dahlia). Following a positive response from the FDA, the company decided in February 2025 to discontinue recruitment for the already-started Phase III trial...The treatment of patients already enrolled in the Phase III trial has subsequently been continued with the locally available Keytruda outside the trial."

Enrollment closed • Melanoma • Solid Tumor

Lotus: Similar Efficacy, Safety, and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P3 | N=25 | Terminated | Sponsor: Formycon AG | Active, not recruiting ➔ Terminated; Formycon concluded that continuing the trial is no longer necessary for the development and approval of FYB206. The therapeutic comparability of FYB206 to Keytruda can be demonstrated based on comprehensive analytical and PK comparability data

Trial termination • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Formycon reports strong operational performance and financial results for first quarter of 2025 (Firstwordpharma Press Release) - "Working capital as of March 31, 2025, stood at €29.4 million (December 31, 2024: €55.1 million). The year-over-year change reflects initial investment savings in FYB206, where development costs are capitalized and thus cash-effective but not EBITDA-relevant. The existing shareholder loan of €48.0 million remains fully available and can be drawn flexibly."

Commercial • Hodgkin Lymphoma • Melanoma • Non Small Cell Lung Cancer

Lotus: Similar Efficacy, Safety, and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P3 | N=25 | Active, not recruiting | Sponsor: Formycon AG | Recruiting ➔ Active, not recruiting | N=524 ➔ 25 | Trial completion date: Feb 2028 ➔ Jun 2025 | Trial primary completion date: Feb 2027 ➔ May 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Formycon announces decision on Phase III trial with FYB206 and provides update on potential need to adjust the valuation of FYB202 and FYB201 (Formycon Press Release) - "The Executive Board of Formycon AG...has decided today to prematurely terminate the Phase III trial ('Lotus') for its biosimilar candidate FYB206. Based on an intensive scientific dialogue with the U.S. Food and Drug Administration (FDA), the Executive Board, after careful consideration, has concluded that the continuation of the study is no longer necessary for the development and approval of FYB206 in the U.S."

Trial termination • Non Small Cell Lung Cancer

Lotus: Similar Efficacy, Safety, and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P3 | N=524 | Recruiting | Sponsor: Formycon AG

Metastases • New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Comparative Analytical Evaluation of the Proposed Biosimilar FYB206 and its Reference Medicinal Product Keytruda®. (PubMed, Drugs R D) - "Based on physicochemical and biological characteristics, FYB206 is suitable to enter the clinical phase."

Journal • Oncology

Dahlia: Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients (clinicaltrials.gov) - P1 | N=94 | Recruiting | Sponsor: Formycon AG

New P1 trial • Melanoma • Oncology • Solid Tumor

FORMYCON ANNOUNCES START OF CLINICAL PHASE III TRIAL FOR KEYTRUDA BIOSIMILAR CANDIDATE FYB206 (Formycon Press Release) - "Formycon AG...announced today that the first patient has been enrolled in the Phase III clinical trial 'Lotus' to compare the safety and efficacy of FYB206/pembrolizumab with the immuno-oncology blockbuster drug Keytruda (First Patient In). The double-blind, multicenter 'Lotus' study is evaluating the best overall response rate (bORR) in patients with non-small cell lung cancer (NSCLC). The comparative treatment comprises up to 17 treatment cycles within 40 weeks....Formycon currently anticipates the earliest market entry of FYB206 after the expiry of the market exclusivity of the reference product in the USA from 2029 and in the EU from 2030. First results of the Phase I trial are expected in 2026. Preliminary results of the Phase III trial are to follow in the course of 2027."

Biosimilar launch • P1 data • P3 data • Trial status • Non Small Cell Lung Cancer

Formycon publishes details of a previously undisclosed pipeline project – FYB206 is a biosimilar candidate for Keytruda (pembrolizumab) (PharmiWeb) - "Formycon AG...announced details of a previously undisclosed project in its development pipeline. FYB206 is a biosimilar candidate for Keytruda^® (pembrolizumab) and the development is at an advanced preclinical stage....The development and commercialization rights for FYB206 are fully owned by Formycon. Important IP has already been created and patent applications have been filed, with data from the development of alternative formulations. Following convincing results from the extensive analytical protein characterization as well as significant progress in the development of the manufacturing process, a comprehensive data package is currently being compiled in order to closely align further program steps in Scientific Advice Meetings with the EMA and FDA in the second half of the year. Adjusting the manufacturing process to commercial scale is planned for the end of 2022."

Commercial • European regulatory • FDA event • Oncology