Ahzantive (aflibercept-mrbb) / Amneal, Formycon, Coherus Biosci, Klinge Pharma, Teva - LARVOL DELTA

Solid business development and market performance in fiscal year 2024 (Formycon Press Release) - "Group revenues in financial year 2024 amounted to €69.7 million, which is above the communicated forecast (€55.0 million to €65.0 million). Compared to the previous year, this represents an anticipated decrease of 10.3% (previous year: €77.7 million). The change is mainly due to the decline in deferred milestone revenues for the FYB202 project from the partnership with Fresenius Kabi. These amounted to €23.1 million in the financial year (previous year: €37.7 million). In addition, revenues from the reimbursement of development activities for FYB201 and FYB203 decreased as expected. On the opposite, one-time proceeds from the sale of excess inventory from the FYB202 development, realized in the amount of €9.5 million, had a positive effect."

Commercial • Age-related Macular Degeneration • Crohn's disease • Diabetic Macular Edema • Immunology • Psoriasis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Formycon receives regulatory approval in the UK for FYB203 (aflibercept), a biosimilar to Eylea, under the brand name AHZANTIVE (Formycon Press Release) - "Formycon AG...and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB203 (aflibercept), a biosimilar to Eylea, under the brand name AHZANTIVE. The approval covers the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal conditions, including Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO)."

MHRA approval • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Edema

Lotus Pharmaceutical becomes strategic partner for the commercialization of Formycon’s Eylea biosimilar FYB203/AHZANTIVE in the Asia-Pacific Region (Formycon Press Release) - "Klinge Biopharma GmbH...the exclusive owner of the global commercialization rights of FYB203/AHZANTIVE (aflibercept), Formycon’s biosimilar to Eylea, informed Formycon AG...that it has concluded an exclusive license agreement with Lotus Pharmaceutical ('Lotus'), a multinational pharmaceutical company, for the commercialization of FYB203/AHZANTIVE in Asia-Pacific ('APAC') countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam as well as the Special Administrative Region Hong Kong. In parallel, Formycon has signed an agreement with Lotus under which Formycon will supply the finished product....Upon signature of the agreement, Klinge will receive upfront payments and is eligible to receive milestone payments on launch and sales. Additionally, Klinge will receive royalties on Lotus’ net sales. Formycon will participate in all Klinge income in the mid-single to low-double-digit percentage range."

Licensing / partnership • Age-related Macular Degeneration

FORMYCON RECEIVES EU APPROVAL FOR FYB203 (AFLIBERCEPT), A BIOSIMILAR TO EYLEA, UNDER THE BRAND NAMES AHZANTIVE AND BAIAMA (Formycon Press Release) - "Formycon AG...and its licensing partner Klinge Biopharma GmbH ('Klinge') today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea, under the brand names AHZANTIVE and Baiama. The approval encompasses the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO)."

EMA approval • Diabetic Macular Edema • Macular Degeneration • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea (aflibercept) in major parts of Europe and in Israel (GlobeNewswire) - "Teva Pharmaceuticals International GmbH...today announced that it has entered into a strategic collaboration with Klinge Biopharma GmbH (Klinge) and Formycon AG...for the semi-exclusive commercialization of FYB203, Formycon's biosimilar candidate to Eylea (aflibercept) in Europe, excluding Italy, and in Israel....Under the terms of the agreement, Teva will lead the commercialization of FYB203 in the designated regions, to be marketed under the brand name AHZANTIVE, subject to regulatory approval. In return, Klinge will receive milestone payments and a portion from the product’s revenue."

Licensing / partnership • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Ocular Safety and Usability Study for FYB203 PFS (clinicaltrials.gov) - P4 | N=30 | Completed | Sponsor: Formycon AG

New P4 trial • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

Ahzantive (European Medicines Agency) - "...the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ahzantive, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO),visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV)."

CHMP • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

FDA GRANTS APPROVAL FOR EYLEA) BIOSIMILAR FYB203/AHZANTIVE) (AFLIBERCEPT-MRBB) (Formycon Press Release) - "Formycon AG...and its licensing partner Klinge Biopharma GmbH ('Klinge') announce that the U.S. Food and Drug Administration ('FDA') today approved FYB203/AHZANTIVE (aflibercept-mrbb), a biosimilar to Eylea....The approval for FYB203/AHZANTIVE is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data."

FDA approval • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

CONVINCING OVERALL PERFORMANCE – FORMYCON REPORTS PRELIMINARY RESULTS FOR THE FINANCIAL YEAR 2023 AND EXCEEDS FORECAST (Formycon Press Release) - "The marketing of the ranibizumab biosimilar FYB201, which is now available in a total of 17 countries worldwide, also contributed to an increase in revenue and net earnings contributions. Revenue resulting from direct participation in the marketing of the Lucentis biosimilar FYB201 amounted to around € 4.1 million....For 2024, the Formycon Group expects sales revenue of between € 55 million and € 65 million. This will mainly result from sales contributions from the marketing proceeds of FYB201, which will be launched in additional countries and regions in 2024. In addition, there is expected revenue from development services for the out-licensed and partnered projects FYB203 and FYB201, which are lower than in previous years due to the advanced stage of the projects."

Biosimilar launch • Commercial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea (Aflibercept) (PharmiWeb) - "Formycon AG...announce that the European Medicines Agency ('EMA') has accepted the marketing authorization application ('MAA') for FYB203, a biosimilar candidate to Eylea® (Active Ingredient: Aflibercept), for review."

European regulatory • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea (Aflibercept) (PharmiWeb) - "Formycon AG...and its license partner Klinge Biopharma GmbH (Klinge) announce that the marketing authorization application (MAA) for FYB203, a biosimilar candidate for Eylea (Active ingredient: Aflibercept) has been submitted to the European Medicines Agency (EMA)."

European regulatory • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Formycon Announces FDA Acceptance of the aBLA for Its Aflibercept Biosimilar (JD Supra) - "Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon’s candidate biosimilar to Regeneron’s EYLEA® (aflibercept). As we previously reported, when Formycon submitted its aBLA in June 2023, it became the second biosimilar developer to announce submission of an aBLA for an aflibercept biosimilar, after Mylan’s (now Viatris’s) submission in October 2021 (Mylan has since transferred its rights to the aflibercept biosimilar and aBLA to Biocon Inc.). According to Formycon, FDA assigned a target action date for the aBLA of June 2024."

BLA • PDUFA date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

MAGELLAN-AMD: Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=434 | Completed | Sponsor: Bioeq GmbH | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA) (Market Screener) - "Formycon AG...and its license partner Klinge Biopharma GmbH...announce that the biologics license application (BLA) for FYB203, a biosimilar candidate for Eylea® (Active ingredient: Aflibercept) has been submitted to the U.S. Food and Drug Administration ('FDA') in line with the initial schedule. Within 60 days after submission, FDA is expected to decide on whether to accept and to further review the BLA ('file acceptance')."

BLA • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Formycon publishes results for financial year 2022 (Yahoo Finance UK) - "From a development perspective, regulatory submissions for...Eylea®6 biosimilar candidate FYB203 to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are expected in 2023."

BLA • European regulatory • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

AFLIBERCEPT BIOSIMILAR CANDIDATE FYB203 SHOWS COMPARABLE EFFICACY TO THE REFERENCE PRODUCT EYLEA IN PHASE III STUDY (Formycon Press Release) - P3 | N=434 | MAGELLAN-AMD (NCT04522167) | Sponsor: Bioeq GmbH | "Formycon AG...published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial for FYB203, its proposed biosimilar to Eylea®....The primary endpoint of the comparative global Phase III trial measures the change in best corrected visual acuity after eight weeks from baseline. The values obtained for FYB203 and the reference product are within the relevant equivalence limits. In addition, to date, the study was conducted without any clinically relevant differences in terms of safety and immunogenicity."

P3 data • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

"$CHRS Coherus Agrees to Acquire Exclusive U.S. Commercial Rights to Eylea® Biosimilar FYB203 from Klinge Biopharma https://t.co/ejOeN9Fv9V" (@stock_titan)

Coherus Agrees to Acquire Exclusive U.S. Commercial Rights to Eylea Biosimilar FYB203 from Klinge Biopharma (GlobeNewswire) - "Coherus BioSciences, Inc...announced today that it has executed a binding term sheet with Klinge Biopharma GmbH (Klinge Biopharma) for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States. The parties expect to complete the transaction in Q1 2023, and Coherus plans to file a Biologics License Application with the U.S. Food and Drug Administration later this year. Coherus intends to launch the product at Eylea® biosimilar market formation, currently expected to be in 2025, if approved."

Biosimilar launch • BLA • Licensing / partnership • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Formycon Q1 2022 Financial Results and Announcement of Two New Biosimilar Products (Big Molecule Watch) - "Formycon recently announced its sales and earnings figures for the first quarter of 2022. Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -4.0 million (Q1/previous year: EUR -1.7 million), which was in line with expectations...the reported revenues were mainly a result of development activities for late-stage biosimilar projects FYB201 (biosimilar candidate for LUCENTIS®), FYB202 (biosimilar candidate for STELARA®), and FYB203 (biosimilar candidate for EYLEA®)."

Financing • Age-related Macular Degeneration • Immunology • Inflammatory Bowel Disease

MAGELLAN-AMD: Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=434 | Active, not recruiting | Sponsor: Bioeq GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

MAGELLAN-AMD: Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Bioeq GmbH | Trial completion date: Oct 2022 ➔ Jun 2023 | Trial primary completion date: Oct 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Pipeline therapies for neovascular age related macular degeneration. (PubMed, Int J Retina Vitreous) - "Prior treatments have included focal laser therapy, verteporfin (Visudyne, Bausch and Lomb, Rochester, New York) ocular photodynamic therapy, transpupillary thermotherapy, intravitreal steroids and surgical excision of choroidal neovascular membranes. Currently, the major therapies in AMD focus on the VEGF-A pathway, of which the most common are bevacizumab (Avastin; Genentech, San Francisco, California), ranibizumab (Lucentis; Genentech, South San Francisco, California), and aflibercept (Eylea; Regeneron, Tarrytown, New York)...Cheaper alternatives, including ranibizumab biosimilars, include razumab (Intas Pharmaceuticals Ltd., Ahmedabad, India), FYB 201 (Formycon AG, Munich, Germany and Bioeq Gmbh Holzkirchen, Germany), SB-11 (Samsung Bioepsis, Incheon, South Korea), xlucane (Xbrane Biopharma, Solna, Sweden), PF582 (Pfnex, San Diego, California), CHS3551 (Coherus BioSciences, Redwood City, California). Additionally, aflibercept biosimilars under development include..."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

MAGELLAN-AMD: Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3; N=400; Recruiting; Sponsor: Bioeq GmbH

Clinical • New P3 trial • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients with Neovascular Age-Related Macular Degeneration (MAGELLAN-AMD) (clinicaltrialsregister.eu) - P3; N=400; Ongoing; Sponsor: Bioeq GmbH

Clinical • New P3 trial