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. 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. 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. Partners formycon and bioeq significantly advance in the development of fyb201. Who are the key lucentis biosimilar players to watch. Jun 01, 2017 its smaller size allows for a higher molar dose per volume and potentially better ocular tissue penetration.
Ranibizumab is also used to treat swelling in the retina caused by diabetes or by a blockage in the blood vessels. 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. News about formycons ranibizumab fyb 201, and ustekinumab fyb. A total of 92 976 treatment episodes from 12 951 eyes of 11 5 patients. 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. 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. A1ewvy and its licensee bioeq ip ag have today published an interim result for the clinical phase iii trial for the biosimilar candidate fyb201.
Nov 29, 2019 ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against vascular endothelial growth factor a vegfa, developed by novartis, for. Formycon and bioeq enroll first patient in pivotal phase iii. 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. 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.
Ranibizumab is a humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor a vegfa. 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. 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. Additional biosimilars targeting vegf are in the pipeline as well. A south korean company is also developing a lucentis biosimilar. 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. Momenta and mylan announce clinical trial of proposed. 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 used in the treatment of various eye diseases in adults which.
Some of the ranibizumab biosimilars and nonoriginator biologicals approved or in development are presented in table 1. 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. Campochiaro, md,2 linda yau, phd,3 zhengrong li, phd,3. Ranibizumab ophthalmic dosage guide with precautions. Detailed ranibizumab ophthalmic dosage information for adults. This longterm approach represents an untapped opportunity as the majority of biosimilar developers are focused on products with patent expirations prior to 2020. Genentech, south san francisco, ca is now upon us, with an expiration date in june of 2020 for the united states. 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. In november 2019, with formycon s assent, bioeq signed an agreement with coherus biosciences to commercialize the biosimilar in the us. Ranibizumab for macular edema due to retinal vein occlusions. Biosimilar ranibizumab candidate fyb201 shows efficacy comparable to the reference product in phase iii study 02. 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.
It lists an eylea biosimilar at the preclinical stage on its. Jun 23, 2010 fda approves lucentis ranibizumab for the treatment of macular edema following retinal vein occlusion. 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. Novartis holds rights to lucentis outside of north america. This prospective study assessed the effect of switching from aflibercept to ranibizumab on anatomical and functional outcomes in patients with persistentrecurrent disease activity. The neovascular agerelated macular degeneration database. A biosimilar version of ranibizumab see adis insight drug profile 800011595 also known as fyb 201 is being developed by formycon, in collaboration with. Formycon and its licensee bioeq today announced positive interim results for a. Lucentis ranibizumab dosing, indications, interactions. Formycons partner bioeq ip plans to file fyb201, a lucentis biosimilar candidate, to treat neovascular agerelated macular degeneration namd with the fda. 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. The monoclonal antibody drug is indicated for the treatment of wet agerelated macular degeneration amd, macular oedema, degenerative myopia and. 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. See the observed effects lucentis treatment had on some wet amd patients to learn why a doctor may prescribe it for you.
Lucentis is a prescription medication given by injection into the eye, and it has side effects. Biosimilar ranibizumab candidate fyb201 shows efficacy comparable to the reference product in phase iii study interim topline data of. Jan 16, 2020 roches reference product lucentis ranibizumab seems to be the next likely target for biosimilar competition. 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. Lucentis ranibizumab ophthalmic uses, side effects. Momenta, mylan plan trial of biosimilar to regeneron eye. 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. Both companies continue to advance biosimilar pipeline. Formycon surfing the next wave of biosimilars edison. The biosimilars race for amd treatments is on ophthalmology. Formycon starts phase iii trial for ranibizumab biosimilar. Biosimilar ranibizumab candidate fyb201 shows efficacy comparable to the reference product in phase iii study. Ranibizumab ophthalmic for the eyes is used to treat the wet form of agerelated macular degeneration. 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.
In this case ranibizumab plays an important role in the treatment of neovascular or wet agerelated macular degeneration namd. Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against vascular endothelial growth factor a vegfa, developed by novartis, for ranibizumab novartis ophthalmics adisinsight. Listing a study does not mean it has been evaluated by the u. 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.
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. 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. 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. Find patient medical information for ranibizumab intravitreal on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. 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 the press release, the primary endpoint in the trial was achieved, confirming comparable efficacy between fyb201 and the reference product in patients with neovascular age.
Xbrane to begin phase 3 trial of ranibizumab biosimilar. New monoclonal antibody treatments in retina retinal physician. Formycon is a biotechnology company focused on biosimilars whose patents expire from 2020 onwards, known as thirdwave biosimilars. Ranibizumab trade name lucentis among others is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Injected ranibizumab to treat macular telangiectasia with new. Biosimilar competition for ranibizumab lies ahead as. 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. 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. Fyb203 is a biosimilar candidate to eylea active ingredient.
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. Formycon ag, a german manufacturer, gave bioeq ip ag exclusive global commercialization rights to fyb201, formycon s ranibizumab biosimilar. Lucentis ranibizumab is a humanized antivegf antibody fragment indicated for the. Formycon projects us biosimilar ranibizumab launch in 2020. A profile on lesserknown player in the biosimilar space.
Germanys formycon ag is far along in testing a biosimilar to eylea rival lucentis from roche. Some lucentis patients have had detached retinas and serious eye infections. 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. 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. 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. A biosimilar version of ranibizumab see adis insight drug profile 800011595.
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. The ophthalmology biosimilars market is still in its infancy. It is partnered with santo holding gmbh on the development of aflibercept. Efficacy and safety of the biosimilar ranibizumab fyb201. If approved in the us marketplace, formycons drug will compete with lucentis, which is approved to treat neovascular agerelated macular. The patents on lucentis will expire in the us in june 2020 and in europe in 2022 1.
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. 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 is a humanized recombinant monoclonal antibody fragment targeted. 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. 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. 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 for macular edema following central retinal vein. Apr 18, 2019 ranibizumab ophthalmic for the eyes is used to treat the wet form of agerelated macular degeneration. 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. Ranibizumab in diabetic macular edema pubmed central pmc. 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. Application bla to the us fda for wetage related macular degeneration. 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. 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. Diabetic macular edema pipeline therapeutics companies and. It is indicated for the wet form of agerelated macular degeneration amd. Formycon and bioeq enroll first patient in pivotal phase. Formycon is a leading, independent developer of highquality followon products for biopharmaceutical medicines known as biosimilars. 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. Formycon s market cap is c 362m and enterprise value ev is c 347m.
Why lucentis ranibizumab injection for wet amd treatment. Ranibizumab for macular edema due to retinal vein occlusions longterm followup in the horizon trial jeffrey s. 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. The twilight of the patent and exclusivity periods covering lucentis ranibizumab. Also in phase 3 development with a ranibizumab biosimilar is formycon. Formycon and bioeq achieve important milestone biosimilar. Formycon releases updates on development programs and. A biosimilar is a copycat of sorts of biological agents, the equivalent to generics of chemicalbased agents. Efficacy and safety of the biosimilar ranibizumab fyb201 in. Mar 21, 2018 however, formycon is not the only company targeting the ocular biosimilar market.
Jun 30, 2006 fda approves lucentis ranibizumab for the treatment of wet agerelated macular degeneration. Biosimilars of ranibizumab general biosimilars home. Ranibizumab may also be used for purposes not listed in this medication guide. Global strategic partners bioeq and formycon initiate pivotal. Includes dosages for macular degeneration, diabetic retinopathy and macular edema. 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. Formycon lucentis biosimilar scores phase iii success. May 02, 2018 formycon and bioeq achieve important milestone.
The patents on lucentis expire in europe in 2022 and in the us in june 2020 1. Formycon and bioeq enroll first patient in pivotal phase iii study with. This time frame is similar to the potential launch of abicipar pegol, and could potentially limit its. Ranibizumab for neovascular agerelated macular degeneration. Formycon licensed fyb201 exclusively to german investment firm santo holding in december 20 2. 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. To study realworld ranibizumab therapy for treatmentnaive eyes with neovascular agerelated macular degeneration namd and to benchmark standards of care. 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. The trial will enroll 650 participants in 89 centers worldwide.
Pfenex has put development of its lucentis biosimilar candidate on hold. The molecular weight is 26 kda compared to 115 kda and 48 kda for aflibercept and ranibizumab, respectively. Anatomical and functional outcomes following switching from. Global strategic partners bioeq and formycon initiate. Ranibizumab is used to treat wet agerelated macular degeneration amd. The company has two assets fyb201 and fyb203 targeting the entire biologics neovascular agerelated macular degeneration namd market, comprising lucentis and eylea. Pfenex, coherus biosciences, siam bioscience, samsung bioepis, and xbrane have all started the development process. Feb 06, 2020 ranibizumab ophthalmic for the eyes is used to treat the wet form of agerelated macular degeneration. The formycon bioeq candidate, known as fyb201, is the subject of the columbusamd trial for treatment of neovascular agerelated macular degeneration.