Aflibercept-mrbb

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."    

MUNICH, Germany I November 27, 2023 I Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (Klinge) announce that the marketing authorization application (MAA) for FYB203, a biosimilar candidate for Eylea® 1 (Active ingredient: Aflibercept) has been submitted to the European Medicines Agency (EMA). Eylea® is used in the treatment of neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. It inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. In the first nine months of 2023, Eylea reached global sales of around US$ 7 billion [[i]] , underlining its status as the currently best-selling drug in the field of anti-VEGF therapies. “Our latest MAA submission once again demonstrates the high performance and reliability of the entire #TeamFormycon. We are very pleased that with FYB203 we have filed our second biosimilar candidate in the ophthalmology space that is likely to become even more important in the coming years in light of the aging population.”, says Formycon CEO Dr. Stefan Glombitza. 1 Eylea ® is a registered Trademark of Regeneron Pharmaceuticals Inc. [i] https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-third-quarter-2023-financial-and-operating About Formycon: Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has six biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207. About Biosimilars: Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Currently, global sales of biosimilars are estimated at more than $15 billion. By 2030, analysts estimate that this figure could rise to over $74 billion. SOURCE: Formycon