2026-07-20
Melt Pharmaceuticals
Samsung Bioepis and Harrow Present Interim Data from a Large-Scale Post-Marketing Surveillance Study on SB11 (BYOOVIZ® / AMELIVU®), a Biosimilar to Lucentis (ranibizumab), at ASRS 2026 harrow.com ↗
2026-06-05
Lupin Limited
Lupin Receives Approval from U.S. FDA for RanluspecTM (ranibizumab) Injection lupin.com ↗
2026-06-03
Xbrane Biopharma AB
Xbrane Biopharma AB (publ) (“Xbrane” or “the Company”) (Nasdaq Stockholm: XBRANE) receives FDA BsUFA date of October 29, 2026 for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) xbrane.com ↗
2026-04-30
Xbrane Biopharma AB
XBRANE SUBMITS RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA xbrane.com ↗
2025-12-23
Zydus Lifesciences Limited
Zydus Partners with Bioeq for U.S. Commercialisation rights for NUFYMCO®, an Interchangeable Biosimilar to Lucentis®. NUFYMCO® BLA has been approved by the USFDA zyduslife.com ↗
2025-12-23
Formycon AG
FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® – Strengthening US Presence with Zydus as Commercialization Partner formycon.com ↗
2025-12-23
Polpharma Biologics S.A.
Bioeq and Zydus partners for U.S. Commercialisation rights for NUFYMCO®, an Interchangeable Biosimilar to Lucentis®. NUFYMCO® BLA has been approved by the USFDA polpharmabiologics.com ↗
2025-11-20
Formycon AG
Ranibizumab Biosimilar Epruvy® launched in Germany formycon.com ↗
2025-11-19
Xbrane Biopharma AB
XBRANE UPDATES ON TIMING FOR RESUBMISSION OF THE BLA FOR ITS RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA xbrane.com ↗
2025-10-21
Formycon AG
Formycon’s FYB201/Ranivisio® sets innovative standard as Europe’s First Ranibizumab Biosimilar available in Pre-filled Syringe formycon.com ↗
2025-10-21
Polpharma Biologics S.A.
Polpharma Biologics announces commercial launch of Europe’s first Pre-filled Syringe presentation of a ranibizumab biosimilar polpharmabiologics.com ↗
2025-10-20
Santen Gmbh
Santen Korea Signs an Exclusive Promotion and Distribution Agreement for VEGF Inhibitors Beovu® and Lucentis® in the Republic of Korea santen.com ↗
2025-10-19
Xbrane Biopharma AB
Xbrane provides Regulatory update on FDA review of its ranibizumab biosimilar candidate xbrane.com ↗
2025-07-01
Formycon AG
Bio Usawa becomes partner for the commercialization of FYB201/BioUcenta™ (ranibizumab) across Sub-Saharan Africa formycon.com ↗
2025-06-05
Formycon AG
Lucentis® biosimilar FYB201/Ranivisio® (ranibizumab) approved in Brazil formycon.com ↗
2025-06-04
Polpharma Biologics S.A.
Lucentis® biosimiliar Ranivisio® (ranibizumab) approved as a new treatment for debilitating retinopathies in Brazil polpharmabiologics.com ↗
2025-05-23
Xbrane Biopharma AB
Xbrane Biopharma AB (publ) (“Xbrane” or “the Company”) (Nasdaq Stockholm: XBRANE) updates on US FDA BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) xbrane.com ↗
2024-12-31
Xbrane Biopharma AB
XBRANE RE-SUBMITS BLA FOR RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA xbrane.com ↗
2024-08-05
Lupin Limited
Lupin Announces Successful Completion of Phase 3 Trials for Lucentis® Biosimilar lupin.com ↗
2024-05-10
Xbrane Biopharma AB
Xbrane and STADA partner with Valorum Biologics to commercialize ranibizumab biosimilar candidate in the US xbrane.com ↗
2024-04-11
Formycon AG
Formycon announces commercial launch of FYB201 (Ranibizumab) in Canada (RanoptoTM) and Switzerland (Ranivisio®) formycon.com ↗
2024-03-11
Formycon AG
FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region formycon.com ↗
2024-01-18
Formycon AG
Formycon Ranibizumab Biosimilar FYB201/CIMERLI® achieved a market share of 38% in the United States in December 2023 formycon.com ↗
2023-12-07
Formycon AG
Health Canada approves FYB201/Ranopto® (Ranibizumab), a biosimilar to Lucentis® formycon.com ↗
2023-11-24
Enzene Biosciences Ltd.
Enzene Biosciences launches biosimilar Ranibizumab enzene.com ↗
2023-11-10
Lupin Limited
Lupin and Amman Pharma Sign Exclusive Licensing and Supply Agreement for Ranibizumab Biosimilar lupin.com ↗
2023-10-10
Formycon AG
Formycon Ranibizumab Biosimilar FYB201/CIMERLI®1 achieved 25% market share2 in the United States formycon.com ↗
2023-10-04
Coherus Oncology, Inc.
CIMERLI® (ranibizumab-eqrn) Sales Exceed 100,000 Doses in First Year of Launch coherus.com ↗
2023-07-25
Xbrane Biopharma AB
STADA and Xbrane weigh options for ranibizumab biosimilar candidate xbrane.com ↗
2023-06-21
Xbrane Biopharma AB
Xbrane announce U.S. FDA filing acceptance for a Lucentis® (ranibizumab) biosimilar candidate xbrane.com ↗
2023-04-25
Xbrane Biopharma AB
STADA and Xbrane supply Ximluci® (ranibizumab) in England under NHS contract xbrane.com ↗
2023-04-24
Xbrane Biopharma AB
XBRANE submits BLA for ranibizumab biosimilar candidate to FDA xbrane.com ↗
2023-02-13
Coherus Oncology, Inc.
Coherus Granted Permanent, Product-Specific Q-Code for CIMERLI® (ranibizumab-eqrn) from the Centers for Medicare and Medicaid Services coherus.com ↗
2023-01-17
Xbrane Biopharma AB
STADA and Xbrane obtain British approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis® xbrane.com ↗
2022-12-15
Xbrane Biopharma AB
XBRANE PROVIDES AN UPDATE ON RANIBIZUMAB BIOSIMILAR CANDIDATE FDA FILING xbrane.com ↗
2022-11-11
Xbrane Biopharma AB
STADA and Xbrane secure EU approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis® xbrane.com ↗
2022-09-19
Coherus Oncology, Inc.
Coherus to Launch CIMERLI™ (ranibizumab-eqrn) in the United States on October 3, 2022 coherus.com ↗
2022-09-16
Xbrane Biopharma AB
STADA and Xbrane welcome EMA positive opinion for ranibizumab biosimilar candidate Ximluci xbrane.com ↗
2022-09-02
Polpharma Biologics S.A.
European Commission approves FYB201/Ranivisio®1 (Ranivisio – Ranibizumab), a biosimilar to Lucentis®2 polpharmabiologics.com ↗
2022-08-29
Formycon AG
European Commission approves FYB201/Ranivisio®1 (Ranivisio - Ranibizumab), a biosimilar to Lucentis®2 formycon.com ↗
2022-08-29
Teva Branded Pharmaceutical Products R&D, Inc.
European Commission grants marketing authorization for Ranivisio▼®* (ranibizumab), a biosimilar to Lucentis®**, for age-related macular degeneration (AMD) the most common cause of blindness in developed countries tevapharm.com ↗
2022-08-26
Formycon AG
Formycon announces EU-Approval of FYB201/Ranivisio®1 a biosimilar to Lucentis®2 formycon.com ↗
2022-08-05
Polpharma Biologics S.A.
U.S. Food and Drug Administration (FDA) approves FYB201/CIMERLI™* (ranibizumab-eqrn), the first and only biosimilar interchangeable with Lucentis®** polpharmabiologics.com ↗
2022-08-03
Formycon AG
U.S. Food and Drug Administration (FDA) approved FYB201/CIMERLITM1 (ranibizumab-eqrn), the first and only biosimilar interchangeable with Lucentis®2 formycon.com ↗
2022-08-03
Formycon AG
Formycon announces FDA approval of FYB201/CIMERLITM1 (ranibizumab-eqrn) as a Biosimilar interchangeable with Lucentis®2 formycon.com ↗
2022-08-02
Coherus Oncology, Inc.
FDA Approves Coherus’ CIMERLI™ (ranibizumab-eqrn) as the First and Only Interchangeable Biosimilar to Lucentis® for All Five Indications, with 12 Months of Interchangeability Exclusivity coherus.com ↗
2022-07-04
Xbrane Biopharma AB
Xbrane provides update on ranibizumab biosimilar candidate FDA filing xbrane.com ↗
2022-06-24
Formycon AG
FYB201, Formycon's biosimilar for Lucentis® (ranibizumab), receives CHMP recommendation from EMA formycon.com ↗
2022-06-02
Biogen
Biogen and Samsung Bioepis’ BYOOVIZ™ (ranibizumab-nuna) Launches in the United States biogen.com ↗
2022-05-30
Xbrane Biopharma AB
Xbrane provides update on ranibizumab biosimilar candidate FDA filing xbrane.com ↗
2022-05-17
Formycon AG
United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) grants Marketing Authorization for FYB201, Formycon's Biosimilar for Lucentis®¹, to be Commercialized by Teva as ONGAVIA® formycon.com ↗
2022-05-17
Formycon AG
FYB201, Formycon's Biosimilar for Lucentis®¹, achieves Marketing Authorization in United Kingdom formycon.com ↗
2022-05-17
Teva Branded Pharmaceutical Products R&D, Inc.
United Kingdom first to grant licence for Teva’s ophthalmology biosimilar Ongavia (ranibizumab)▼ tevapharm.com ↗
2021-12-14
Polpharma Biologics S.A.
Polpharma Biologics Group announces that its joint venture company, Bioeq, has entered into a commercialization agreement for biosimilar Ranibizumab polpharmabiologics.com ↗
2021-12-14
Polpharma Biologics S.A.
Bioeq, the Polpharma Biologics Group joint venture company and MS Pharma sign exclusive agreement for Ranibizumab in MENA polpharmabiologics.com ↗
2021-10-04
Polpharma Biologics S.A.
Polpharma Biologics Group announces that the Biologics License Application (BLA) submitted by its joint venture Bioeq for its biosimilar Ranibizumab has been accepted for review by the U.S. Food and Drug Administration (FDA) polpharmabiologics.com ↗
2021-10-04
Coherus Oncology, Inc.
Positive Results of Clinical Trial Comparing Coherus’ Ranibizumab Biosimilar Candidate CHS-201 to Reference Product Lucentis® (Ranibizumab) in the Treatment of Neovascular (Wet) Age-Related Macular Degeneration (nAMD) Presented at Retina Society Annual Scientific Meeting coherus.com ↗
2021-10-01
Formycon AG
Formycon and Bioeq announce File Acceptance for FYB201, a biosimilar candidate to Lucentis® (ranibizumab) by the U.S. Food and Drug Administration (FDA) formycon.com ↗
2021-10-01
Coherus Oncology, Inc.
Coherus Announces BLA Filing for Lucentis® (ranibizumab) Biosimilar Candidate Accepted by FDA for Review coherus.com ↗
2021-09-30
Xbrane Biopharma AB
Xbrane Biopharma AB announces that partner STADA’s Marketing Authorization Application for ranibizumab is submitted and validated by European Medicines Agency xbrane.com ↗
2021-09-20
Biogen
FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna) biogen.com ↗
2021-08-06
Polpharma Biologics S.A.
Polpharma Biologics Group announces that its joint venture Bioeq has submitted a biologics license application (BLA) for biosimilar Ranibizumab to the U.S. Food and Drug Administration (FDA) polpharmabiologics.com ↗
2021-08-05
Formycon AG
Formycon and Bioeq announce submission of the biologics license application (BLA) for FYB201, a biosimilar candidate to Lucentis(R)1 (ranibizumab) to the U.S. Food and Drug Administration (FDA) formycon.com ↗
2021-06-29
Formycon AG
Formycon and Bioeq announce submission of the marketing authorization application for FYB201, a biosimilar candidate to Lucentis(R)1 (ranibizumab) to the European Medicines Agency (EMA) formycon.com ↗
2021-06-28
Formycon AG
Teva Pharmaceutical Industries Ltd. becomes strategic partner for the commercialization of FYB201, Formycon's biosimilar candidate to Lucentis(R)1 (ranibizumab) in Europe, Canada, Israel and New Zealand formycon.com ↗
2021-06-25
Biogen
Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Ranibizumab Biosimilar, BYOOVIZ™ biogen.com ↗
2021-06-24
Hoffmann-La Roche
FDA accepts application for Roche’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD) roche.com ↗
2021-06-23
Genentech, Inc.
FDA Accepts Application for Genentech’s Port Delivery System With Ranibizumab (PDS) for Treatment of Wet Age-Related Macular Degeneration (AMD) gene.com ↗
2021-03-01
Formycon AG
Formycon confirms BLA-Submission Strategy and Timeline for its Lucentis(R)* Biosimilar-Candidate FYB201 following consultation with the FDA formycon.com ↗
2020-11-18
Biogen
Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab) biogen.com ↗
2020-10-06
Biogen
Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11, a Proposed Biosimilar Referencing Lucentis® (ranibizumab) biogen.com ↗
2020-07-22
Hoffmann-La Roche
Phase III data show Roche’s Port Delivery System with ranibizumab enabled over 98% of patients to go six months between treatments for neovascular age-related macular degeneration roche.com ↗
2020-07-22
Genentech, Inc.
Phase III Data Show Port Delivery System With Ranibizumab Enabled Over 98% of Patients to Go Six Months Between Treatments for Neovascular Age-Related Macular Degeneration gene.com ↗
2020-05-27
Hoffmann-La Roche
Roche’s Port Delivery System with ranibizumab shows positive phase III results in neovascular age-related macular degeneration roche.com ↗
2020-05-26
Genentech, Inc.
Port Delivery System With Ranibizumab Shows Positive Phase III Results in Neovascular Age-Related Macular Degeneration gene.com ↗
2019-11-06
Coherus Oncology, Inc.
Coherus Acquires Commercial Rights for Leading Lucentis Biosimilar in the United States coherus.com ↗
2019-07-26
Novartis Pharmaceuticals
Novartis receives positive CHMP opinion for Lucentis® treatment in preterm infants with retinopathy of prematurity (ROP), a disease causing visual impairment and blindness novartis.com ↗
2019-04-04
ThromboGenics
Oxurion NV announces full enrollment of its Phase 2 trial evaluating efficacy and safety of the combination of anti-PlGF (THR-317) and anti-VEGF (ranibizumab) for the treatment of DME, ahead of schedule oxurion.com ↗
2018-10-04
Xbrane Biopharma AB
Xbrane Biopharma announces results of in-vivo study showing equivalent tolerability and pharmacokinetic profile of Xlucane compared to Lucentis® xbrane.com ↗
2018-09-22
Novartis Pharmaceuticals
Novartis to file for new Lucentis® (ranibizumab) indication in retinopathy of prematurity (ROP), a rare disease in premature infants that often leads to blindness novartis.com ↗
2018-07-25
Genentech, Inc.
Genentech Unveils Positive Phase II Results for the Port Delivery System with Ranibizumab (PDS), the First-Ever Eye Implant to Achieve Sustained Delivery of a Biologic Medicine to Treat People With Wet Age-Related Macular Degeneration (AMD) gene.com ↗
2018-05-01
Formycon AG
Formycon and Bioeq Achieve Important Milestone: Biosimilar Ranibizumab Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase III Study formycon.com ↗
2018-04-27
BioInvent International AB
BioInvent's collaboration partner ThromboGenics initiates a Phase II combination study with the drug candidate THR-317 and ranibizumab bioinvent.com ↗
2018-04-27
ThromboGenics
ThromboGenics Initiates Phase 2 Clinical Study Evaluating anti-PlGF (THR-317) in combo with anti-VEGF (ranibizumab) for treatment of DME oxurion.com ↗
2018-03-21
Genentech, Inc.
FDA Approves Genentech’s Lucentis (Ranibizumab Injection) 0.3 mg Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy gene.com ↗
2018-01-30
Celon Pharma SA
Raport bieżący nr 3/2018 – Podpisanie umowy na rozwój przemysłowy i wytwarzanie do badań klinicznych białka anty-VEGF – leku biopodobnego do Lucentis celonpharma.com ↗
2018-01-30
Celon Pharma SA
Podpisanie umowy na rozwój przemysłowy i wytwarzanie do badań klinicznych białka anty-VEGF – leku biopodobnego do Lucentis celonpharma.com ↗
2017-04-18
Hoffmann-La Roche
FDA approves Roche’s Lucentis (ranibizumab injection) for diabetic retinopathy, the leading cause of blindness among working age adults in the United States roche.com ↗
2017-04-17
Genentech, Inc.
FDA Approves Genentech’s Lucentis (Ranibizumab Injection) for Diabetic Retinopathy, the Leading Cause of Blindness Among Working Age Adults in the United States gene.com ↗
2017-01-05
Genentech, Inc.
FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Myopic Choroidal Neovascularization gene.com ↗
2016-12-07
Novartis Pharmaceuticals
Novartis' Lucentis® received EU approval in new indication - Lucentis the only treatment available for a wide range of CNV conditions novartis.com ↗
2016-10-14
Genentech, Inc.
FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) Prefilled Syringe gene.com ↗
2016-10-10
Genentech, Inc.
FDA Grants Priority Review to Genentech’s Lucentis® (Ranibizumab Injection) Supplemental Biologics License Application for Myopic Choroidal Neovascularization gene.com ↗
2016-02-22
Formycon AG
Formycon and bioeq enroll first patient in pivotal phase III study with biosimilar ranibizumab (FYB201) formycon.com ↗
2015-10-06
Formycon AG
Global strategic partners bioeq and Formycon initiate pivotal phase III clinical trial with their Lucentis® biosimilar formycon.com ↗
2015-02-06
Genentech, Inc.
FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Treatment of Diabetic Retinopathy in People with Diabetic Macular Edema gene.com ↗
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