The objective of the study is to assess the ocular safety of the FYB203 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.

开始日期2024-09-20

申办/合作机构

Formycon AG

NCT04522167 / Completed临床3期

A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration

This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.

开始日期2020-07-21

申办/合作机构

bioeq GmbH

100 项与阿柏西普生物类似药 (Formycon) 相关的临床结果

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100 项与阿柏西普生物类似药 (Formycon) 相关的转化医学

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100 项与阿柏西普生物类似药 (Formycon) 相关的专利（医药）

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项与阿柏西普生物类似药 (Formycon) 相关的文献（医药）

International journal of retina and vitreous

Pipeline therapies for neovascular age related macular degeneration

Review

作者: Arepalli, Sruthi ; Kaiser, Peter K

Abstract:

Age related macular degeneration (AMD) is the most common cause of vision loss in the elderly population. Neovascular AMD comprises 10% of all cases and can lead to devastating visual loss due to choroidal neovascularization (CNV). There are various cytokine pathways involved in the formation and leakage from CNV. 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). Anti-VEGF agents have revolutionized our treatment of wet AMD; however, real world studies have shown limited visual improvement in patients over time, largely due to the large treatment burden. 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 FYB203 (Formycon AG, Munich, Germany and Bioeq Gmbh Holzkirchen, Germany), ALT-L9 (Alteogen, Deajeon, South Korea), MYL1710 (Momenta Pharamaceuticals, Cambridge, MA, and Mylan Pharmacueticals, Canonsburg, PA), CHS-2020 (Coherus BioSciences, Redwood City, California). Those in the pipeline of VEGF targets include abicipar pegol (Abicipar; Allergan, Coolock, Dublin), OPT-302 (Opthea; OPTHEA limited; Victoria, Melbourne), conbercept (Lumitin; Chengdu Kanghong Pharmaceutical Group, Chengdu, Sichuan), and KSI-301 (Kodiak Sciences, Palo Alto, CA). There are also combination medications, which target VEGF and PDGF, VEGF and tissue factor, VEGF and Tie-2, which this paper will also discuss in depth. Furthermore, long lasting depots, such as the ranibizumab port delivery system (PDS) (Genentech, San Francisco, CA), as well as others are under evaluation. Gene therapy present possible longer treatments options as well and are reviewed here. This paper will highlight the past approved medications as well as pipeline therapies for neovascular AMD.

项与阿柏西普生物类似药 (Formycon) 相关的新闻（医药）

2024-11-15

·Endpoints

European drug regulators offer wave of positive recommendations following Leqembi reversal

The European Medicines Agency’s human medicines committee handed down a slew of positive recommendations for drugs on Friday, including Merck’s blockbuster cancer drug Keytruda and InflaRx’s monoclonal antibody Gohibic for Covid-19. The committee recommended label expansions for 11 drugs, including the Keytruda-pemetrexed-platinum chemotherapy combination for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma, and Bristol Meyers Squibb’s Opdivo-Yervoy combination for the first-line treatment of a type of unresectable or metastatic colorectal cancer. Eight new medicines were recommended for approval, including a marketing authorization under exceptional circumstances for Gohibic for the treatment of SARS‑CoV2‑induced acute respiratory distress syndrome. The FDA granted it an emergency use authorization last year. InflaRx noted in a statement that the exceptional circumstances recommendation means that the benefit-risk assessment of the drug is positive — but “due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use.” InflaRx added that approval in the EU is expected early next year and that it’s considering potential partnerships for commercial distribution. Bristol Myers’ oral tyrosine kinase inhibitor, Augtyro, won a conditional marketing authorization recommendation for advanced solid tumors and locally advanced or metastatic non-small cell lung cancer. Four biosimilars were also recommended, including: Formycon’s Baiama and Klinge Biopharma’s Ahzantive as biosimilars to Eylea for several forms of macular degeneration and other eye diseases; Samsung Bioepis’ denosumab biosimilars Obodence for osteoporosis and bone loss, and Xbryk for the prevention of issues like fractures in adults with bone tumors. Samsung Bioepis touted the recommendations, noting that if the European Commission authorizes the drugs, they would be Samsung Bioepis’ first endocrinology biosimilars approved in Europe. The committee also rejected two drugs: Legacy Healthcare’s Cinainu for the treatment of alopecia areata, a disease that causes hair loss, and Orphelia Pharma’s Kizfizo for the treatment of neuroblastoma. These decisions come on the heels of the committee reversing course and deciding in favor of Eisai and Biogen’s Alzheimer’s treatment Leqembi on Thursday for the treatment of a subset of early-stage Alzheimer’s patients who have one or no copies of a form of a gene called APOE4. That gene can make it more likely that a patient experiences brain imaging abnormalities known as ARIA, an adverse event linked with Leqembi. The committee originally recommended against Leqembi in a broader Alzheimer’s population over the summer.

上市批准加速审批

2024-08-12

·Firstwordpharma

Sandoz's Enzeevu becomes fourth Eylea biosimilar to win US nod

The FDA has approved Sandoz's Enzeevu (aflibercept-abzv), making it the fourth biosimilar version of Regeneron Pharmaceuticals' eye disease drug Eylea (aflibercept) to receive US regulatory clearance in recent weeks. However, Enzeevu carries a narrower label than other approved biosimilars of the anti-VEGF therapy.Enzeevu is approved to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (AMD). The FDA has also provisionally determined that Enzeevu would be interchangeable with the original medicine, though it can't currently be marketed as interchangeable due to existing exclusivity rights for the first interchangeable biosimilars.The decision announced Monday follows closely on the heels of three other Eylea biosimilar approvals: Biocon's Yesafili (aflibercept-jbvf) and Samsung Bioepis/Biogen's Opuviz (aflibercept-yszy) – both of which have interchangeable status – as well as Formycon/Klinge Biopharma's Ahzantive (aflibercept-mrbb), which along with AMD are all also authorised for macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy.Legal action ongoingThe rapid succession of approvals comes as Regeneron has been actively pursuing legal action against biosimilar developers, including seeking injunctions to delay market entry. Eylea's exclusivity ran out around mid-May, with Yesafili and Opuviz securing FDA approvals in the days following. Ahzantive was greenlit about a month later.However, a judge in the US District Court for the Northern District of West Virginia awarded Regeneron a permanent injunction in June against the launch of Yesafili and a preliminary injunction in its lawsuit against Opuviz. Regeneron sought to block sales of the potential Eylea rivals by narrowing its bid to treatment claims under a single US patent, No. 11,084,865, which covers VEGF antagonist formulations suitable for intravitreal administration.As a result, the timing of Enzeevu's market entry remains up in the air. "Launch timing will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements," Sandoz said in a statement.Eylea has been a significant revenue driver for Regeneron, with US sales reaching $5.7 billion in 2023. However, the drug faces increasing competition not only from biosimilars, but also from Roche's Vabysmo (faricimab-svoa). In response, Regeneron has been promoting a high-dose version of Eylea, which brought in $304 million in second-quarter sales of this year, according to the company's most recent earnings report.

上市批准专利侵权专利到期生物类似药优先审批

2024-07-01

·FiercePharma

Regulatory tracker: Sandoz, Samsung Bioepis gain FDA approval for biosimilar to J&J's Stelara

Check back to this tracker for regulatory updates on marketed drugs, including expansions into new geographies and indications. (Pixabay) Welcome to Fierce Pharma's regulatory tracker for the second half of 2024. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. UPDATED: Monday, July 1 at 8:51 a.m. Sandoz and Samsung Bioepis' Pyzchiva, a biosimilar to Johnson & Johnson's Stelara, has gained FDA approval. The agency provisionally endorsed the biosimilar as an interchangeable product, meaning that in some cases it can be substituted at the pharmacy counter without a doctor's permission. Sandoz will commercialize the biosimilar in the U.S. under the partnership between the companies. The biosimilar is set to reach the market in February of next year thanks to a settlement the partners struck with Johnson & Johnson in November. Pyzchiva is approved to treat plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis in adults. In pediatric patients, the biosimilar is approved to treat moderate to severe plaque psoriasis and active psoriatic arthritis. Also on the biosimilar front, Formycon's biosimilar to Regeneron's blockbuster Eylea has gained an FDA nod. Branded as Ahzantive, the new biosim joins Formycon's Lucentis biosimilar on its roster of approved therapies. The FDA approved Ahzantive to treat wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy and macular edema following retinal vein occlusion. Formycon did not detail its launch plans in its approval press release. The European Commission has approved Valneva's Ixchiq as a single-dose vaccine to protect against chikungunya virus. Ixchiq is the world's first chikungunya vaccine, having gained prior approvals in the U.S. and Canada. Other regulatory reviews are progressing in the U.K. and Brazil, Valneva said in a press release. "In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas in Europe that were previously unaffected," Valneva's chief medical officer, Juan Carlos Jaramillo, M.D., said in a statement. "It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks."

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100 项与阿柏西普生物类似药 (Formycon) 相关的药物交易

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适应症	国家/地区	公司	日期
糖尿病性黄斑水肿	美国	Formycon AG	2024-06-28
糖尿病性视网膜病变	美国	Formycon AG	2024-06-28
视网膜静脉阻塞相关黄斑水肿	美国	Formycon AG	2024-06-28
湿性年龄相关性黄斑变性	美国	Formycon AG	2024-06-28