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SCD-411

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SCD-411
Clinical Trials
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CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025

• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases. • AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics. • Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.

Celltrion Secures EU Approval for Denosumab Biosimilars Targeting Osteoporosis and Cancer Complications

• Celltrion receives European Commission approval for Stobocolo and Osenvelt, biosimilar versions of Prolia and Xgeva (denosumab), following successful Phase 3 trials demonstrating equivalence. • Stobocolo gains approval for postmenopausal osteoporosis and bone loss treatment, while Osenvelt is authorized for preventing bone metastasis complications and treating giant cell bone tumors. • The approval positions Celltrion to compete in a market worth approximately $6.23 billion, marking the company's third European biosimilar approval this month.

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

• 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.

Global Diabetic Retinopathy Clinical Trials Landscape Analysis Reveals Key Research Trends for 2024

• A comprehensive analysis of global diabetic retinopathy clinical trials has been released, offering insights into trial distribution across G7 and E7 countries and various research phases. • The report highlights significant trends in trial enrollment patterns over the past five years, providing valuable data for healthcare stakeholders and pharmaceutical companies. • The analysis covers detailed assessment of trial statuses, sponsor types, and endpoint evaluations, helping identify key opportunities and challenges in diabetic retinopathy research.

EMA Panel Recommends Aflibercept Biosimilar Eydenzelt for Retinal Disorders

• 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.

Health Canada Approves Celltrion's Omlyclo, First Omalizumab Biosimilar

• Health Canada has approved Omlyclo, Celltrion's biosimilar of omalizumab, for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria. • The approval was based on a Phase III trial demonstrating bioequivalence to Xolair in efficacy, safety, pharmacokinetics, and immunogenicity in CSU patients. • Celltrion also received positive CHMP opinions for biosimilars of aflibercept, denosumab, and tocilizumab, expanding its biosimilar portfolio in Europe. • Omlyclo is under review with the FDA, potentially offering a more accessible treatment option for various allergic conditions in the US market.

FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara

• 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

• 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.

Formycon's Aflibercept Biosimilar (FYB203) Receives Positive CHMP Opinion for EU Approval

• Formycon's FYB203, a biosimilar to aflibercept (Eylea®), has received a positive opinion from the CHMP for marketing authorization in the EU. • The CHMP recommends FYB203, to be marketed as AHZANTIVE® and Baiama®, for treating nAMD, DME, CNV, and macular edema following RVO. • The European Commission is expected to make a final approval decision in the second half of January 2025, expanding treatment options for retinal diseases. • FYB203, already FDA-approved, inhibits VEGF and aims to provide a cost-effective alternative to the originator product, which had global sales of $9 billion in 2023.

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

• 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.

Formycon's Aflibercept Biosimilar, AHZANTIVE®/Baiama®, Receives Positive CHMP Opinion for EU Approval

• Formycon's biosimilar candidate FYB203, to Regeneron's Eylea® (Aflibercept), has received a positive opinion from the CHMP for marketing authorization in the EU. • The recommendation supports approval for treating neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and other retinal diseases. • Clinical data demonstrated comparable efficacy, safety, and immunogenicity to Eylea® in nAMD patients, supporting the biosimilar's approval. • The European Commission's final decision on market authorization for AHZANTIVE®/Baiama® is anticipated in the second half of January 2025.

Formycon's Aflibercept Biosimilar FYB203 Receives Positive CHMP Opinion for EU Approval

• Formycon's biosimilar candidate FYB203, also known as AHZANTIVE®/Baiama®, has received a positive opinion from the EMA's CHMP for marketing authorization. • The recommendation supports FYB203's approval in the EU for treating neovascular age-related macular degeneration (nAMD) and other retinal diseases. • The CHMP's decision was based on comprehensive data demonstrating comparable efficacy, safety, and immunogenicity to the reference drug Eylea® (aflibercept). • The European Commission is expected to grant central marketing authorization in the second half of January 2025, pending the final decision.

Formycon's Aflibercept Biosimilar FYB203 Receives Positive CHMP Opinion for EU Approval

• Formycon's FYB203, a biosimilar to Aflibercept (Eylea®), has received a positive opinion from the EMA's CHMP for marketing authorization in the European Union. • The recommendation supports FYB203's use in treating neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and other retinal diseases. • The CHMP's decision was based on comprehensive data demonstrating comparable efficacy, safety, and immunogenicity to the reference drug, Eylea®. • The European Commission is expected to grant final marketing authorization in the second half of January 2025, pending their review of the CHMP's assessment.

EMA's CHMP Recommends Multiple New Medicines and расширения Indications in November and December 2024 Meetings

• The CHMP recommended eight medicines for approval in November, including Augtyro for advanced solid tumors and Lazcluze for first-line treatment of advanced non-small cell lung cancer. • Seventeen new medicines were recommended for approval in December, bringing the total for 2024 to 114, including Andembry for hereditary angioedema and Beyonttra for transthyretin amyloidosis. • Extensions of therapeutic indication were recommended for 11 medicines in November and 8 in December, expanding the use of already authorized treatments like Keytruda and Ofev. • The CHMP also reviewed and updated recommendations for several medicines, including Leqembi for Alzheimer's disease and Mysimba for weight loss, and addressed the withdrawal of Alofisel for Crohn's disease.

Cobenfy: A Novel Schizophrenia Treatment Approved by FDA

• The FDA approved Cobenfy (xanomeline and trospium chloride) as a first-in-class treatment for schizophrenia, offering a new mechanism of action. • Cobenfy targets cholinergic receptors, unlike traditional dopamine receptor-targeting drugs, potentially reducing adverse side effects. • Clinical trials demonstrated significant improvements in schizophrenia symptoms with Cobenfy, including positive, negative, and cognitive aspects. • While promising, further research is needed to assess long-term tolerability and comparative effectiveness, with cost being a consideration.

FDA Accepts Alvotech and Teva's Biosimilar Application for Golimumab (AVT05)

• The FDA has accepted the BLA for AVT05, a biosimilar to Simponi/Simponi Aria (golimumab), marking the first such acceptance in the U.S. • AVT05 is intended for inflammatory conditions like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. • The FDA's decision on AVT05 is expected in Q4 2025, potentially offering a cost-saving alternative for patients. • Clinical studies have demonstrated comparable efficacy, safety, and immunogenicity between AVT05 and the reference golimumab.

Biosimilar Updates: Trastuzumab, Adalimumab, Ustekinumab, and Aflibercept

• The FDA approved a higher 420mg strength of Hercessi (trastuzumab-strf), a biosimilar to Herceptin, for HER2-positive breast and gastric cancers, expanding treatment options. • UnitedHealth will remove AbbVie’s Humira from some preferred drug lists in 2025, favoring adalimumab biosimilars, reflecting the increasing biosimilar market share. • Evernorth will offer an interchangeable ustekinumab biosimilar for Stelara at $0 out-of-pocket cost, potentially saving patients around $4,000 annually. • The EMA's CHMP issued a positive opinion for Samsung Bioepis’ Opuviz (SB15), an aflibercept biosimilar referencing Eylea, for ophthalmic diseases.

CHMP Recommends Aflibercept Biosimilar OPUVIZ for Retinal Disorders

• The European Medicines Agency's CHMP has issued a positive opinion for OPUVIZ, an aflibercept biosimilar developed by Samsung Bioepis and Biogen. • OPUVIZ is recommended for treating neovascular age-related macular degeneration, macular edema secondary to retinal vein occlusion, and diabetic macular edema. • A Phase 3 trial demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics between OPUVIZ and reference aflibercept. • If approved by the European Commission, OPUVIZ will be the second ophthalmology biosimilar in Samsung Bioepis' portfolio commercialized by Biogen.

Accord BioPharma's Hercessi (trastuzumab-strf) Receives FDA Approval for 420mg Strength

• Accord BioPharma's Hercessi (trastuzumab-strf), a biosimilar to Herceptin, has received FDA approval for its 420mg strength, expanding treatment options for HER2-overexpressing cancers. • The approval includes indications for adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma. • Clinical data demonstrated Hercessi's similarity to Herceptin in efficacy, safety, and quality, supporting its use as a cost-effective alternative. • Accord BioPharma plans to commercially launch Hercessi in the U.S. in early 2025, adding to their growing portfolio of biosimilars aimed at reducing healthcare costs.

FDA Approves Ahzantive, a Biosimilar to Eylea, for Retinal Diseases

• The FDA has approved Ahzantive (aflibercept-mrbb) as a biosimilar to Eylea for treating retinal diseases. • Ahzantive is indicated for neovascular age-related macular degeneration, diabetic macular edema, and other retinal conditions. • Clinical data showed Ahzantive's efficacy, safety, pharmacokinetics, and immunogenicity are comparable to Eylea. • The approval expands affordable treatment options for retinal diseases, with potential EMA approval expected by early 2025.
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