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Details:
CIMERLI (Ranibizumab) is the first and only interchangeable biosimilar with an exclusivity for 12 months after market launch that is indicated for the treatment of all five Lucentis® indications and, as such, is a new medical option for patients with serious retinal diseases.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Cimerli
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2022
Details:
CIMERLI™ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI™. Hypersensitivity reactions may manifest as severe intraocular inflammation
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Cimerli
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2022
Details:
Under the exclusive agreement, MS Pharma will be responsible for the registration and commercialization of FYB201/CHS-201 (Ranibizumab), in the Middle East and North African countries. MS Pharma will start the registration procedures in MENA immediately.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: CHS-201
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: MS Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 14, 2021
Details:
CHS-201 (ranibizumab), trade name Lucentis® among others is a monoclonal anti-angiogenic antibody fragment (Fab) that has been approved to treat the "wet" type of age-related macular degeneration a common form of age-related vision loss.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: CHS-201
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2021
Details:
OPT-302, a VEGF-C/D inhibitor being investigated for neovascular age-related macular degeneration. It binds to and neutralizes the activity of VEGF-C and VEGF-D by preventing ligand binding to the endogenous receptors VEGFR-2 and VEGFR-3.
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2023
Details:
Ximluci (ranibizumab) binds and inhibits VEGF-A, including VEGF110, preventing the interaction of VEGF-A with VEGFR1 and VEGFR2 on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Ximluci
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Xbrane Biopharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 16, 2023
Details:
CIMERLI (ranibizumab-eqrn) is indicated for patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Cimerli
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
Ranivisio (ranibizumab) is indicated for the treatment of neovascular (wet) age-related macular degeneration, treatment of visual impairment due to diabetic macular oedema or choroidal neovascularization, proliferative diabetic retinopathy, as well as visual impairment.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Ranivisio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Bioeq IP AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2022
Details:
Cimerli (ranibizumab-eqrn), a VEGF inhibitor, is indicated for treatment of patients with neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Cimerli
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Brand Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2022
Details:
The COLUMBUS-AMD study, published in highly-regarded medical journal Ophthalmology, was the head-to-head study where CIMERLI (ranibizumab) met its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week 8 as compared to reference ranibizumab.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Cimerli
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Polpharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 02, 2022
Details:
The active substance of Ranivisio is ranibizumab, a monoclonal antibody fragment (ATC code: S01LA04) which modulates angiogenesis by inhibiting vascular endothelial growth factor A. Ranivisio is a biosimilar medicinal product.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Ranivisio
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2022
Details:
BYOOVIZ™ (ranibizumab-nuna), priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Byooviz
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Samsung Bioepis
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
MHRA granted a licence for Ongavia® (ranibizumab), a biosimilar to Lucentis®*, for the treatment of (wet) age-related macular degeneration (AMD) and several other eye diseases, such as diabetic macular oedema and proliferative diabetic retinopathy.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Ongavia
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Bioeq IP AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2022
Details:
Of the 366 participants dosed for OPT-302, 66 (18%) were identified as having PCV lesions at baseline based on multimodal imaging analysis of color fundus photography, fluorescein angiography and SD-OCT.
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
OPT-302 is a first-in-class VEGF-C/D inhibitor. It is a soluble fusion protein comprising immunoglobulin-like domains 1 to 3 of extracellular domain of vascular endothelial growth factor receptor 3 fused to Fc fragment of human IgG1.
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2022
Details:
Under the terms of this agreement, Axantia will register, hold the marketing authorization and commercialize Ranibizumab in certain territories including Saudi Arabia, Jordan, Iraq, Lebanon and GCC countries.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Razumab
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Intas Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement April 04, 2022
Details:
The data presented was a prespecified subgroup analysis of a Phase 2b dose-ranging study of intravitreal OPT-302 in combination with ranibizumab, compared with ranibizumab alone, in participants with neovascular age-related macular degeneration (wet AMD).
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Details:
Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Susvimo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2021
Details:
OPT-302, a VEGF-C/D ‘trap’, to be used in combination with existing standard of care anti-VEGF-A therapies. OPT-302 has the potential to address the unmet medical need of wet age-related macular degeneration (AMD) and diabetic macular edema (DME) patients.
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2021
Details:
CHS-201 (also known as FYB201) is being developed as a proposed biosimilar to the reference product, Lucentis® (ranibizumab) used in the treatment of neovascular (wet) age-related macular degeneration (nAMD).
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: CHS-201
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
The ShORe and COAST registrational studies are expected to each enroll approximately 990 treatment naïve patients and are evaluating OPT-302 combination therapy as a potential treatment for wet AMD.
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
The initiation of the Phase 3 pivotal clinical program follows the positive outcomes from the Phase 2b clinical trial of OPT-302 in 366 patients with wet AMD, which demonstrated that OPT-302, in combination with standard of care anti-VEGF-A therapy, ranibizumab (Lucentis).
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 2021
Details:
FYB201 (Ranibizumab) is used in treatment of various eye diseases in adults which cause damage to retina, thereby impairing vision. In these diseases, protein called VEGF causes excessive blood vessels to form within retina, resulting in a progressive loss of central vision.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: FYB201
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Formycon
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2021
Details:
This Fast Track designation acknowledges the significant unmet medical need in the management of neovascular AMD, and the potential role that OPT-302 may have in addressing it.
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2021
Details:
Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Byooviz
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2021
Details:
Proceeds from the financing will be used to advance clinical development of AffaMed's robust pipeline of innovative therapeutic candidates, progress business development and partnering activities, and support preparations for future commercialization.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: SB11
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Lake Bleu Capital
Deal Size: $170.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing March 30, 2021
Details:
Following consultations with US FDA and EU EMA, two pivotal Phase 3 clinical trial designs are finalized to assess 2 mg OPT-302 administered 4-weekly or 8-weekly in combination with Lucentis® (ShORe study) and Eylea® (COAST study) standard of care.
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Details:
If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in Europe; BENEPALI™, IMRALDI™ and FLIXABI™.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: SB11
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2020
Details:
SB11 is the sixth biosimilar product and the first eye disease treatment that Samsung Bioepis developed after three autoimmune disease treatments (SB2, SB4, SB5) and two tumor disease treatments (SB3, SB8).
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: SB11
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2020
Details:
European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis® (ranibizumab).
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: SB11
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Samsung Bioepis
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
Opthea is working on a new drug that targets other VEGF proteins from those approved, including Bayer/Regeneron’s Eylea as well as Lucentis, namely VEGF-C and VEGF-D, for use in combination with VEGF-A drugs.
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 25, 2020
Details:
The outcome of the meetings supports the progression of OPT-302 into Phase 3 and pre-commercial development. The company is on-track to initiate Phase 3 trials in early 2021.
Lead Product(s): OPT-302,Ranibizumab
Therapeutic Area: Ophthalmology Product Name: OPT-302
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 21, 2020
Details:
In the Archway study, Port Delivery System with ranibizumab (PDS) demonstrated non-inferior and equivalent visual acuity outcomes compared with monthly ranibizumab eye injections, and a favourable benefit-risk profile.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Lucentis
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2020
Details:
In a Phase 3 study, SB11 demonstrated equivalent efficacy in terms of change in best corrected visual activity (BCVA) at Week 8 and central subfield thickness (CST) at Week 4 to reference ranibizumab LUCENTIS®i in patients with neovascular age-related macular degeneration.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: SB11
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
Formycon continues to work with license partner Bioeq AG and its manufacturing partner on the resubmission of the Biologics License Application (BLA) for the FYB201 project, a biosimilar candidate for Lucentis(R)* (Ranibizumab), despite the situation regarding COVID-19.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2020
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A Polish CDMO of active pharmaceutical ingredients (API), significant European API producer, delivering products to companies worldwide
