Formycon AG | MedPath

Formycon's Ustekinumab Biosimilar FYB202 Shows Comparable Efficacy to Stelara® in Clinical Studies

3 months ago

• Formycon's FYB202 demonstrated analytical and functional comparability to reference ustekinumab (Stelara®) through comprehensive laboratory testing and clinical studies. • Phase III efficacy study involving 392 psoriasis patients and Phase I pharmacokinetics study with 491 healthy volunteers confirmed therapeutic equivalence of FYB202. • The biosimilar received regulatory approvals from FDA, EMA, Health Canada, and UK's MHRA between September 2024 and January 2025, expanding treatment access.

Formycon Halts Phase III Trial of FYB206 Following FDA Feedback, Faces Market Challenges for Biosimilars

3 months ago

• Formycon terminates Phase III "Lotus" trial for FYB206 biosimilar after FDA confirms therapeutic comparability can be demonstrated through existing melanoma study data and analytical program. • Company anticipates significant valuation adjustments for FYB202 due to higher-than-expected price discounts in the U.S. biosimilar market, potentially requiring impairment in the high double-digit to low triple-digit million range. • Commercialization of FYB201/CIMERLI® likely to pause temporarily due to increasing price competition among ranibizumab providers, leading to potential valuation adjustments.

Formycon's Aflibercept Biosimilar (FYB203) Gains EU Approval for Retinal Diseases

4 months ago

• The European Commission has granted marketing authorization for Formycon's FYB203 (aflibercept) biosimilar, to be marketed as AHZANTIVE® and Baiama®. • FYB203 is approved for treating neovascular age-related macular degeneration (nAMD) and other retinal diseases like diabetic macular edema (DME). • Teva Pharmaceuticals will commercialize FYB203 under the brand name AHZANTIVE® in major European markets, expanding patient access. • The approval offers a cost-effective alternative to Eylea®, which had global sales of approximately USD 9 billion in 2023.

Otulfi (Ustekinumab) Biosimilar Gains Regulatory Approvals in Canada and the UK for Inflammatory Diseases

4 months ago

• Health Canada approved Otulfi, a ustekinumab biosimilar, for subcutaneous and intravenous use in treating Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis. • The UK's MHRA also approved Otulfi for the same indications, following approvals in the US and Europe, expanding treatment options for inflammatory diseases. • Otulfi, developed by Formycon and commercialized by Fresenius Kabi, targets interleukin-12 and interleukin-23, offering a cost-effective alternative to Stelara. • These approvals underscore the commitment to increasing access to biosimilars, potentially reducing healthcare costs and improving patient access to essential medicines.

EMA Panel Recommends Aflibercept Biosimilar Eydenzelt for Retinal Disorders

5 months ago

• The EMA's CHMP has issued a positive opinion for Celltrion's Eydenzelt, a biosimilar to aflibercept (Eylea), for treating retinal disorders. • Eydenzelt is recommended for neovascular AMD, diabetic macular edema, macular edema following retinal vein occlusion and myopic choroidal neovascularisation. • A Phase III study demonstrated Eydenzelt's therapeutic equivalence to aflibercept, with similar efficacy, safety, pharmacokinetics, and immunogenicity in DME patients. • The European Commission will now decide on marketing authorization, adding to the growing list of approved aflibercept biosimilars in 2024.

Formycon Partners with MS Pharma to Commercialize Ustekinumab Biosimilar in MENA Region

5 months ago

• Formycon AG and MS Pharma have entered into a licensing and supply agreement for the commercialization of FYB202, a biosimilar to Stelara® (ustekinumab), in the Middle East and North Africa (MENA) region. • MS Pharma will have the rights to license, commercialize, and produce FYB202 locally in Saudi Arabia for GCC countries and other MENA countries, enhancing patient access to vital treatments. • Formycon will receive an upfront payment and royalty payments from sales, further strengthening the collaboration between the two companies following the successful launch of FYB201 in the MENA region. • Regulatory approvals for FYB202 have been granted in the U.S. and Europe, with MS Pharma planning to submit for regulatory approval in MENA countries at the earliest opportunity.

FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara

6 months ago

• The FDA has approved Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce) as biosimilars to Stelara, offering new options for patients with autoimmune and inflammatory conditions. • Steqeyma and Yesintek are approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, mirroring Stelara's indications. • These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.

Formycon's FYB206, a Keytruda Biosimilar, Enters Clinical Development Amidst Strong Financial Results

6 months ago

• Formycon's biosimilar candidate FYB206, referencing Keytruda, has commenced its clinical development program, including Phase I and Phase III studies, marking a significant milestone. • The company reported successful Q3 results with approvals for FYB202 (ustekinumab biosimilar) in the U.S. and Europe, triggering milestone payments from partner Fresenius Kabi. • FYB203 (aflibercept biosimilar) received a positive CHMP opinion for treating neovascular age-related macular degeneration and other retinal diseases, expected to be finalized in January 2025. • Formycon's FYB201 (ranibizumab biosimilar) has achieved substantial market share in the U.S. and UK, with ongoing expansion into additional global markets.

CHMP Issues Positive Opinion for Aflibercept Biosimilar FYB203

6 months ago

• The European Medicines Agency's CHMP has recommended FYB203, an aflibercept biosimilar, for marketing authorization. • FYB203 is intended for treating neovascular age-related macular degeneration, diabetic macular edema, and other retinal diseases. • The European Commission is expected to make a final decision on approval in the second half of January 2025. • FYB203, already FDA-approved, will be marketed as AHZANTIVE and Baiama in the European Union.

CHMP Recommends Aflibercept Biosimilar FYB203 for Retinal Diseases

6 months ago

• The CHMP has issued a positive opinion for FYB203, an aflibercept biosimilar, recommending it for marketing authorization in Europe. • FYB203 is intended for treating nAMD, DME, CNV, and macular edema following RVO in adult patients. • The European Commission's final decision is expected in the second half of January 2025, with trade names AHZANTIVE and Baiama. • FYB203 received FDA approval in June 2024, marking a significant step in providing affordable treatment options for retinal diseases.

Aflibercept Biosimilars Gain Momentum in Europe with Multiple Approvals and Positive Opinions

6 months ago

• The European Medicines Agency's CHMP recommended Amgen's Pavblu and Skojoy, aflibercept biosimilars, for approval in January 2025, expanding treatment options for retinal diseases. • Sandoz's Afqlir (aflibercept) received marketing authorization from the European Commission, offering an affordable alternative for conditions like neovascular AMD, expected to launch in Q4 2025. • Several aflibercept biosimilars, including Samsung Bioepis' OPUVIZ and Formycon's FYB203, have recently been approved or received positive opinions, increasing patient access to AMD treatments.