Ranibizumab is a humanized recombinant monoclonal antibody fragment targeted. Mar 21, 2018 however, formycon is not the only company targeting the ocular biosimilar market. Roches lucentis ranibizumab, which also treats amd, macular edema following retinal vein occlusion, dme, and diabetic retinopathy in patients with dme, faces challenges from formycon s fyb201, samsung bioepis sb11, pfenexs pf582, and intas razumab approved as a. Formycon s market cap is c 362m and enterprise value ev is c 347m. The article presents recent data on which the practice of ranibizumab injections for diabetic macular edema is based, and highlights issues regarding efficacy, safety, and other important considerations for any retina provider using ranibizumab in practice. Formycon says that fyb201, referenced on roches lucentis, is the worlds only biosimilar candidate for ranibizumab that has progressed to a phase 3 clinical trial, and that an innovative application system underpinned by the companys own patent applications puts the drug maker in a highly promising position to capture a. Nov 29, 2019 ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against vascular endothelial growth factor a vegfa, developed by novartis, for. Who are the key lucentis biosimilar players to watch. The trial will investigate the biosimilarity of xbranes potential ranibizumab biosimilar, which it hopes to eventually market as xlucane, versus the reference lucentis in patients with wet agerelated macular degeneration amd. May 02, 2018 formycon and bioeq achieve important milestone. Lucentis is a prescription medication given by injection into the eye, and it has side effects. A profile on lesserknown player in the biosimilar space. Why lucentis ranibizumab injection for wet amd treatment.
Lucentis ranibizumab ophthalmic uses, side effects. It is indicated for the wet form of agerelated macular degeneration amd. Ranibizumab for macular edema due to retinal vein occlusions longterm followup in the horizon trial jeffrey s. Treatment with ranibizumab inhibits certain growth factors involved in the formation of new vessels, with the result that deterioration of visual performance can be slowed down or even stopped altogether. According to this, the primary endpoint has been achieved in the columbusamd trial, thus confirming comparable efficacy between fyb201 and the reference medicinal product lucentis. Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against vascular endothelial growth factor a vegfa, developed by novartis, for ranibizumab novartis ophthalmics adisinsight.
Lucentis ranibizumab dosing, indications, interactions. Formycon is a leading, independent developer of highquality followon products for biopharmaceutical medicines known as biosimilars. Biosimilars of ranibizumab general biosimilars home. Efficacy and safety of the biosimilar ranibizumab fyb201 in comparison to lucentis in patients with neovascular agerelated macular degeneration columbusamd the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Lucentis is also approved for macular edema following retinal vein occlusion rvo and diabetic macular edema dme, but because of nuances in the biosimilars approval process formycon may not get approval for all three indications when and if approval should come.
In november 2019, with formycon s assent, bioeq signed an agreement with coherus biosciences to commercialize the biosimilar in the us. Like lucentis, eylea is used in the treatment of neovascular agerelated macular degeneration namd, along with several other serious eye diseases. Apr 18, 2019 ranibizumab ophthalmic for the eyes is used to treat the wet form of agerelated macular degeneration. Ranibizumab is approved for use for several ophthalmologic indications, including wet agerelated macular degeneration, diabetic retinopathy and diabetic macular edema, myopic choroidal neovascularization, and macular edema following retinal vein occlusion. Formycon and bioeq initiate pivotal phase iii clinical trial for fyb201, an investigational biosimilar ranibizumab lucentis global program underscores formycon s and bioeqs leadership in ophthalmology biosimilars. Formycon and its licensee bioeq today announced positive interim results for a. The patents on lucentis expire in europe in 2022 and in the us in june 2020 1. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire added value chain from technical development to the clinical phase iii and. Formycon projects us biosimilar ranibizumab launch in 2020. Nov 28, 2017 german firm formycon has a pipeline of thirdwave biosimilar products in development with its lead candidate fyb201, a version of rochegenentechs wet agerelated macular degeneration amd drug lucentis ranibizumab, in phase iii trials. Ranibizumab is a humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor a vegfa. Momenta and mylan announce clinical trial of proposed. Formycon ag, a german manufacturer, gave bioeq ip ag exclusive global commercialization rights to fyb201, formycon s ranibizumab biosimilar.
Injected ranibizumab to treat macular telangiectasia with new. Biosimilar ranibizumab candidate fyb201 shows efficacy comparable to the reference product in phase iii study. A biosimilar is a copycat of sorts of biological agents, the equivalent to generics of chemicalbased agents. Genentech, south san francisco, ca is now upon us, with an expiration date in june of 2020 for the united states. Xbrane to begin phase 3 trial of ranibizumab biosimilar. Biosimilar ranibizumab candidate fyb201 shows efficacy comparable to the reference product in phase iii study interim topline data of. Ranibizumab may also be used for purposes not listed in this medication guide. A south korean company is also developing a lucentis biosimilar.
A1ewvy and its licensee bioeq ip ag have today published an interim result for the clinical phase iii trial for the biosimilar candidate fyb201. The monoclonal antibody drug is indicated for the treatment of wet agerelated macular degeneration amd, macular oedema, degenerative myopia and. Jun 30, 2006 fda approves lucentis ranibizumab for the treatment of wet agerelated macular degeneration. Partners formycon and bioeq significantly advance in the development of fyb201. German drug maker formycon released its third quarter financial results on monday, and reported that it plans to launch its biosimilar ranibizumab candidate, fyb201, in the united states in 2020. It is an antiangiogenic that has been approved to treat the wet type of agerelated macular degeneration amd, also armd, a common form of agerelated vision loss.
Fyb203 is a biosimilar candidate to eylea active ingredient. Formycon says that fyb201, referenced on roches lucentis, is the worlds only biosimilar candidate for ranibizumab that has progressed to a phase 3 clinical trial, and. Formycon and bioeq enroll first patient in pivotal phase iii study with. A biosimilar version of ranibizumab see adis insight drug profile 800011595 also known as fyb 201 is being developed by formycon, in collaboration with.
If approved in the us marketplace, formycons drug will compete with lucentis, which is approved to treat neovascular agerelated macular. Ranibizumab for macular edema due to retinal vein occlusions. The ophthalmology biosimilars market is still in its infancy. Formycon ag and its licensee bioeq ip ag have recently published an interim result for the clinical phase iii trial for the biosimilar candidate fyb201. It lists an eylea biosimilar at the preclinical stage on its. German firm formycon has a pipeline of thirdwave biosimilar products in development with its lead candidate fyb201, a version of rochegenentechs wet agerelated macular degeneration amd drug lucentis ranibizumab, in phase iii trials. Formycon starts phase iii trial for ranibizumab biosimilar posted 112015 german biosimilars companies formycon and bioeq announced on 7 october 2015 that they had initiated a pivotal phase iii clinical trial with their candidate ranibizumab biosimilar fyb201. Detailed ranibizumab ophthalmic dosage information for adults.
A total of 92 976 treatment episodes from 12 951 eyes of 11 5 patients. Formycons partner bioeq ip plans to file fyb201, a lucentis biosimilar candidate, to treat neovascular agerelated macular degeneration namd with the fda. Formycon s partner bioeq ip plans to file fyb201, a lucentis biosimilar candidate, to treat neovascular agerelated macular degeneration namd with the fda imminently in q419. Ranibizumab ophthalmic dosage guide with precautions. Some of the ranibizumab biosimilars and nonoriginator biologicals approved or in development are presented in table 1. Jun 23, 2010 fda approves lucentis ranibizumab for the treatment of macular edema following retinal vein occlusion. Formycon starts phase iii trial for ranibizumab biosimilar. This prospective study assessed the effect of switching from aflibercept to ranibizumab on anatomical and functional outcomes in patients with persistentrecurrent disease activity. Nov 23, 2015 efficacy and safety of the biosimilar ranibizumab fyb201 in comparison to lucentis in patients with neovascular agerelated macular degeneration columbusamd the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Formycon covers the entire range of biosimilar medicines development, from technicalpharmaceutical development to clinical trials, all the way through to preparation and submission of dossiers for regulatory approval by international authorities. Mar 29, 2016 formycon, the germanbased developer of biosimilar agents, may be getting a leg up in the race to develop biosimilars for intravitreal antivegf agents as it launched the first phase iii pivotal trial of its biosimilar to genentechs lucentis ranibizumab while also revealing details of its program to develop a biosimilar to regenerons eylea aflibercept. Columbusamd study investigates the comparability of fyb201, an investigational biosimilar ranibizumab, and lucentis in patients with neovascular agerelated macular degeneration namd study involves 650 participants in around 80 clinical centers worldwide. Ranibizumab for macular edema following central retinal vein.
This study will examine whether the drug ranibizumab is an effective treatment for macular telangiectasia, a condition in which existing blood vessels near the macula the back part of the eye responsible for sharp central vision become dilated and twisted, and new abnormal blood vessels may form under the retina. The biosimilars race for amd treatments is on ophthalmology. Pfenex has put development of its lucentis biosimilar candidate on hold. Novartis holds rights to lucentis outside of north america. Diabetic macular edema pipeline therapeutics drugs market insights 2017 provides in depth insights on the pipeline drugs and their development activities around the diabetic macular. Formycon and bioeq enroll first patient in pivotal phase iii. Biosimilar ranibizumab candidate fyb201 shows efficacy comparable to the reference product in phase iii study 02. Ranibizumab ophthalmic for the eyes is used to treat the wet form of agerelated macular degeneration.
You should not use lucentis if you have an infection in or around the eye or are allergic to lucentis or any of its ingredients. The company has two assets fyb201 and fyb203 targeting the entire biologics neovascular agerelated macular degeneration namd market, comprising lucentis and eylea. The molecular weight is 26 kda compared to 115 kda and 48 kda for aflibercept and ranibizumab, respectively. Formycon and its licensee bioeq today announced positive interim results for a phase 3 clinical trial of fyb201, a proposed ranibizumab biosimilar referencing lucentis, which is an antivascular endothelial growth factor therapy approved to treat patients with neovascular agerelated macular degeneration namd. For the treatment of minimally classic and occult agerelated macular degeneration, ranibizumab retarded the progression of the disease and improved visual acuity in some patients.
Oct 07, 2015 formycon and bioeq initiate pivotal phase iii clinical trial for fyb201, an investigational biosimilar ranibizumab lucentis global program underscores formycons and bioeqs leadership in ophthalmology biosimilars. With biosimilar ranibizumab in latephase development and positive topline data already announced for formycon bioeqs biosimilar fyb201, 6 the first lucentis biosimilar could launch as early as 2020 in the united states and 2022 in europe. Some lucentis patients have had detached retinas and serious eye infections. May 31, 2018 developers of fyb201 may be getting a leg up in the race for a lucentis biosimilar with the publication of interim results that confirm the efficacy of the candidate for monthly treatment of neovascular agerelated macular degeneration namd, with plans to bring it to market in 2020. Ranibizumab is used to treat wet agerelated macular degeneration amd. A1ewvy published an update on development programs and key milestones for fyb201, new data from the recently completed columbusamd phase iii trial in patients with neovascular agerelated macular degeneration namd are available. During the ranibizumab the first 3 months of the study, all 744 rvo patients received an injection at baseline and the majority also received injections at month 1 and month 2. Ranibizumab is used in the treatment of various eye diseases in adults which. The twilight of the patent and exclusivity periods covering lucentis ranibizumab. Jun 01, 2017 its smaller size allows for a higher molar dose per volume and potentially better ocular tissue penetration. A biosimilar version of ranibizumab, designated pf 582, was being developed by pfenex, for the treatment of wet agerelated macular degeneration, diabetic ranibizumab biosimilar pfenex. Also in phase 3 development with a ranibizumab biosimilar is formycon. Biosimilar ranibizumab candidate fyb201 shows efficacy comparable to the reference product in phase iii study interim topline data of columbusamd trial show comparable efficacy between fyb201 and lucentis ranibizumab primary endpoint of the global phase iii study achieved. Formycon and its licensee bioeq today announced positive interim results for a phase 3 clinical trial of fyb201, a proposed ranibizumab biosimilar referencing lucentis, which is an antivascular endothelial growth factor therapy approved to treat patients with neovascular agerelated macular degeneration.
This time frame is similar to the potential launch of abicipar pegol, and could potentially limit its. Application bla to the us fda for wetage related macular degeneration. Feb 06, 2020 ranibizumab ophthalmic for the eyes is used to treat the wet form of agerelated macular degeneration. Ranibizumab trade name lucentis among others is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Anatomical and functional outcomes following switching from. In this case ranibizumab plays an important role in the treatment of neovascular or wet agerelated macular degeneration namd. Backgroundaims prospective data on switching antivascular endothelial growth factors in patients with neovascular agerelated macular degeneration namd who have previously shown nopartial response are limited. Additional biosimilars targeting vegf are in the pipeline as well. Formycon lucentis biosimilar scores phase iii success. Ranibizumab can be used to treat macular degeneration by inhibiting vegf, which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. Campochiaro, md,2 linda yau, phd,3 zhengrong li, phd,3. Efficacy and safety of the biosimilar ranibizumab fyb201 in.
Find patient medical information for ranibizumab intravitreal on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Formycon is in the early stages of developing a phase 3 trial for its biosimilar version of eylea aflibercept or fyb 203, the next generation of macular degeneration treatment. Ranibizumab, which is approved to treat neovascular agerelated macular degeneration amd, macular edema following retinal vein occlusion, diabetic macular edema dme, and diabetic retinopathy in patients with dme. According to this, the primary endpoint has been achieved in the columbusamd trial, thus confirming comparable efficacy between fyb201 and the reference medicinal product lucentis in patients.
Diabetic macular edema pipeline therapeutics companies and. The patents on lucentis will expire in the us in june 2020 and in europe in 2022 1. New monoclonal antibody treatments in retina retinal physician. Efficacy and safety of the biosimilar ranibizumab fyb201. Lucentis ranibizumab is a humanized antivegf antibody fragment indicated for the. Ranibizumab is also used to treat swelling in the retina caused by diabetes or by a blockage in the blood vessels. Jan 16, 2020 roches reference product lucentis ranibizumab seems to be the next likely target for biosimilar competition.
Formycon and bioeq initiate pivotal phase iii clinical trial for fyb201, an investigational biosimilar ranibizumab lucentis global program underscores formycons and bioeqs leadership in ophthalmology biosimilars. A biosimilar version of ranibizumab see adis insight drug profile 800011595. Momenta, mylan plan trial of biosimilar to regeneron eye. Ranibizumab in diabetic macular edema pubmed central pmc. News about formycons ranibizumab fyb 201, and ustekinumab fyb. Formycon and bioeq enroll first patient in pivotal phase. See the observed effects lucentis treatment had on some wet amd patients to learn why a doctor may prescribe it for you. Formycon surfing the next wave of biosimilars edison. Ranibizumab for neovascular agerelated macular degeneration. Formycon and bioeq enroll first patient in pivotal phase iii study with biosimilar ranibizumab fyb201 columbusamd study investigates the comparability of fyb201, an investigational biosimilar ranibizumab, and lucentis in patients with neovascular agerelated macular degeneration namd. Biosimilar ranibizumab candidate fyb201 shows efficacy comparable to the reference product in phase iii study interim topline data of columbusamd trial show comparable efficacy between fyb201 and lucentis r ranibizumab primary endpoint of the global phase iii study achieved.
Formycon licensed fyb201 exclusively to german investment firm santo holding in december 20 2. Formycon and bioeq achieve important milestone biosimilar. Both companies continue to advance biosimilar pipeline. Formycon releases updates on development programs and. Globaldata further predicts that the first eylea biosimilar, bioeq formycon s fyb203, will launch in 2025 in the eu and 2026 in the us and japan. Listing a study does not mean it has been evaluated by the u. Jul 02, 2018 the news may give formycon ag of germany and its swissbased licensee, bioeq ip ag, the advantage, at least for the moment, in the race to develop a biosimilar of lucentis ranibizumab, rochegenentech. The trial will enroll 650 participants in 89 centers worldwide. Global strategic partners bioeq and formycon initiate. This longterm approach represents an untapped opportunity as the majority of biosimilar developers are focused on products with patent expirations prior to 2020. Globaldata anticipates the launch of the first lucentis biosimilar, fyb201, which is codeveloped by bioeq and formycon, in 2020 in the us, 2022 in the eu, and 2023 in japan.