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Scientific Name: ranibizumab

2022

Formycon and Athos announce closing of acquisition

May 10, 2022

Formycon and Athos KG announced closing of the acquisition by Formycon of 100% of the rights to FYB201 (biosimilar ranibizumab), a 50% of the rights to FYB202 (biosimilar ustekinumab), together with Bioeq GMBH, which is described as its “long-time partner”.  The total value of the deal is €650M.

Opthea presents data for OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in combination with ranibizumab for polypoidal choroidal vasculopathy

May 5, 2022

Opthea Limited presented data for OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in combination with ranibizumab for polypoidal choroidal vasculopathy at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting.  Opthea reported that OPT-302 used in combination with ranibizumab achieved superior visual acuity gains and anatomic improvements compared to monthly ranibizumab monotherapy.

MENA | Axantia to commercialise ranibizumab biosimilar in the Middle East

April 4, 2022

4 Apr 22 Intas announced that it has signed an exclusive license and supply agreement with Axantia, a Middle Eastern pharmaceutical company, for the commercialisation of ranibizumab (biosimilar Lucentis®) in territories including Saudi Arabia, Jordan, Iraq and Lebanon.

Formycon and Athos KG announce long-term strategic partnership for biosimilars

March 29, 2022

Formycon and Athos KG announced that they have agreed to enter into a long-term strategic partnership regarding biosimilars.  As part of this agreement, Formycon will acquire 100% of the rights in FYB202 (biosimilar ustekinumab candidate) and a 50% stake in FYB201 (biosimilar ranibizumab candidate) in exchange for EUR 650 million.

CA | Health Canada approves Byooviz™ (biosimilar ranibizumab)

March 10, 2022

Samsung Bioepis and Biogen announced that Health Canada approved Byooviz™ (biosimilar ranibizumab) on 8 March for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization (CNV) secondary to pathologic myopia (PM) and choroidal neovascularization (CNV) secondary to ocular conditions other than AMD or PM.  This is the first Health Canada approval of a biosimilar ranibizumab to date, and whilst is it Samsung’s 6th Canadian biosimilar, it is Biogen’s first.  Byooviz™ was approved in the US in September 2021, and in the EU and the UK in August 21.

Samsung Bioepis secured 10 biosimilar products on its 10th year anniversary

February 28, 2022

The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10th year anniversary.  Six biosimilars have been approved globally: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab and ranibizumab.  Eculizumab has recently completed its Ph III clinical trial, and three other biosimilar candidates are under Ph III trials.

Coherus Biosciences enters into new loan agreement

January 7, 2022

Coherus Biosciences announced that it has entered into a loan agreement with investment funds managed by Pharmakon Advisors, LP.   The agreement will provide Coherus with up to $300 million committed across four tranches.  The third and fourth tranches are conditional upon Coherus receiving approval of the BLA for its toripalimab and its biosimilar ranibizumab, respectively.

2021

US | FDA approves Susvimo™ (ranibizumab) for intravitreal use via ocular implant for the treatment of wet age-related macular degeneration

October 22, 2021

Genentech announced that the FDA has approved Susvimo™ (ranibizumab) for intravitreal use via ocular implant for the treatment of patients with wet age-related macular degeneration who have previously responded to at least two anti-VEGF injections.

US | FDA accepts for review the BLA for CHS-201 (proposed biosimilar ranibizumab)

October 1, 2021

Coherus Biosciences announced that the FDA has accepted for review the BLA for CHS-201 (proposed biosimilar ranibizumab).

EU | MAA for Xlucane™ (proposed biosimilar ranibizumab) submitted to the EMA

September 30, 2021

Xbrane Pharma and STADA announced that the MAA for Xlucane™ (proposed biosimilar ranibizumab) has been submitted to the EMA.

US | FDA approves Byooviz® (biosimilar ranibizumab)

September 20, 2021

Samsung Bioepis and Biogen announced that the FDA has approved Byooviz® (biosimilar ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, macular edema and myopic choroidal neovascularisation.

Samsung Bioepis announces new data from Ph III clinical study of Byooviz® (ranibizumab biosimilar)

September 9, 2021

Samsung Bioepis announced results from a post-hoc and subgroup analysis of a Ph III clinical study of Byooviz® (ranibizumab biosimilar). Samsung Bioepis reported that the data supports biosimilarity between Byooviz® and reference ranibizumab.

EU | EMA approves Byooviz® (biosimilar ranibizumab)

September 8, 2021

The EMA approved Samsung Bioepis and Biogen’s Byooviz® (biosimilar ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular oedema, proliferative diabetic retinopathy, macular edema and choroidal neovascularisation.

US | Formycon and Bioeq submit BLA for proposed ranibizumab biosimilar

August 5, 2021

Formycon and Bioeq announced that the BLA for FYB201 (proposed ranibizumab biosimilar) has been submitted to the FDA.

Coherus Biosciences releases its Q2 2021 financial results

August 5, 2021

Coherus Biosciences released its Q2 2021 financial results. Coherus announced that its partner, Junshi Biosciences plans to submit the BLA for toripalimab for a number of indications later this quarter. Coherus also disclosed that it anticipates a mid-2022 target action date for its BLA for biosimilar ranibizumab, and confirmed it plans to launch its biosimilar adalimumab on or after 1 July 2023.

IN | India’s CDSCO grants marketing authorisation for Lupin’s ranibizumab biosim

July 6, 2021

India’s Central Drugs Standard Control Organisation granted marketing authorisation for Lupin’s ranibizumab biosimilar.

STADA and XBrane provide update on Xlucane™ (proposed ranibizumab biosimilar)

June 29, 2021

STADA and XBrane BioPharma announced that Xlucane™ (proposed ranibizumab biosimilar) met its primary endpoint in a pivotal comparability trial. STADA disclosed that it plans to submit the MAA and BLA for Xlucane™ to the EMA and FDA respectively in the second half of 2021.

EU | Bioeq submits MAA for proposed ranibizumab biosimilar

June 29, 2021

Bioeq announced that it has submitted the MAA for FYB201 (proposed ranibizumab biosimilar) to the EMA. Under the agreement announced on 28 June 2021, FYB201 will be marketed in the EU by Teva.

Teva and Bioeq enter biosimilar ranibizumab agreement

June 28, 2021

Teva and Bioeq announced they have entered into a strategic partnership for the exclusive commercialisation of Bioeq’s FYB201 (proposed ranibizumab biosimilar). Under the agreement, Bioeq will be responsible for the development, registration and supply of the product, while Teva will gain commercialisation rights in Europe, Canada, Israel and New Zealand.

EU | CHMP recommends Byooviz™ (proposed ranibizumab biosimilar)

June 25, 2021

Samsung Bioepis and Biogen announced that the CHMP has recommended BYOOVIZ™/SB11 (proposed ranibizumab biosimilar) for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization.

US | FDA accepts BLA for Genentech’s ranibizumab Port Delivery System

June 23, 2021

Genentech announced that the FDA has accepted the BLA for its Port Delivery System (PDS) with ranibizumab under Priority Review. Genentech is seeking approval for its PDS for the treatment of wet, or neovascular, age-related macular degeneration (AMD).

Coherus reports Q1 2021 financial results

May 6, 2021

Coherus BioSciences reported its Q1 2021 financial results.  Coherus disclosed that it has commenced the rolling submission of the BLA for toripalimab and that it expects to file the BLA for CHS-201 (proposed ranibizumab biosimilar) mid-2021.

EU | US | Samsung Bioepis presents similar data for proposed ranibizumab biosimilar

May 1, 2021

Samsung Bioepis announced a new study demonstrating the structural, physicochemical and biological similarity between its SB11 (proposed ranibizumab biosimilar) and Lucentis®.  The BLA and MA for SB11 are currently before the FDA and EMA respectively.

US | Coherus reports Q420 and Full Year 2020 financial results

February 24, 2021

Coherus released its Q420 and Full Year 2020 financial results. Coherus reported it has captured 21% of the pegfilgrastim market and nearly 50% of the pre-filled syringe segment in the US. Additionally, Coherus announced it plans to file its BLA for its ranibizumab biosimilar mid-year 2021. Coherus also confirmed that it plans to launch its adalimumab biosimilar in the US on or after July 1, 2023.

2020

Roche releases results of faricimab

December 23, 2020
Roche announces results for its investigational bispecific antibody faricimab in patients with diabetic macular edema. Roche announced that the candidate was generally well-tolerated with no new safety signals identified. This product is being developed as a replacement for Lucentis® (ranibizumab), which lost patent protection in the US this year.

US | FDA accepts Samsung Bioepis and Biogen’s ranibizumab application

November 18, 2020

Samsung Bioepis and Biogen announce the FDA has accepted for review the BLA for SB11 (proposed ranibizumab biosimilar).

Samsung Bioepis announces one-year results of ranibizumab biosimilar

November 11, 2020

Samsung Bioepis announces one-year results from Ph III study of SB11 (proposed ranibizumab biosimilar) at the American Academy of Ophthalmology 2020 Virtual. Samsung reported the data confirms equivalence in efficacy and pharmocokinetics as well as a comparable safety and immunogenicity profile.

US | Formycon announces adjusted submission strategy for ranibizumab biosimilar

November 5, 2020

Formycon announces its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted. The approval will now be requested directly for a large commercial scale, which Formycon and Bioeq expect will simplify the approval procedure.

EU | Samsung Bioepis and Biogen Marketing Authorisation Application reviewed

October 6, 2020

Samsung Bioepis and Biogen announce the European Medicines Agency has accepted for review its Marketing Authorisation Application for SB11 (proposed ranibizumab biosimilar).

Regenxbio commences dosing in Ph II trials

September 20, 2020

Regenxbio announces it has commenced dosing in Ph II trials comparing RGX-314 to monthly ranibizumab injections. RGX-314 is being developed as a novel, one-time subretinal treatment for wet AMD and diabetic retinopathy.

Xbrane intentions to file application for Xlucane® reported

September 1, 2020

Generics update reports Xbrane is aiming to file an application for Xlucane® (biosimilar ranibizumab) in Europe and the US, and to license the product in Latin America, Japan and China in the next 12 months.

Results of UK Kings College/NHS Trust MERLOT trial reported

August 28, 2020

Healio reports the results of the UK Kings College/NHS Trust MERLOT trial demonstrated there was no benefit to epimacular brachytherapy as an adjunct to anti-VEGF injections, the results of which were worse than ranibizumab monotherapy, for the treatment of neovascular age-related macular degeneration.

US | Polpharm’s plans to file modified application reported

August 11, 2020

The Centre for Biosimilars reports that Polpharma is planning to file a modified application for FYB201 (biosimilar ranibizumab candidate) to the FDA within the next year.

Genentech Ph III Archway study results released

July 22, 2020

Genentech publishes the results from its Ph III Archway study, evaluating its Port Delivery System (PDS) with ranibizumab for the treatment of neovascular age-related macular degeneration (nAMD).  Genentech reported that 98.4% of patients were able to go six months without requiring additional treatment, and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections.

Novartis Q2 FY20 financial results released

July 21, 2020

Novartis releases its Q2 FY20 financial results, reporting COVID-19 negatively impacted demand for Lucentis® (ranibizumab).

Samsung Bioepis Ph III trial results of SB11 released

May 18, 2020

Samsung Bioepis announces 24-week interim results from a Ph III trial of SB11 (a proposed ranibizumab biosimilar) in patients with neovascular age-related macular degeneration. Samsung Bioepis announced that the primary endpoints of the trial were met, suggesting that SB11 will be a valuable treatment option for nAMD.

Update on Formycon biosimilar portfolio released

May 15, 2020

Formycon releases an update on its biosimilar portfolio. In the statement, Formycon confirmed it is continuing to work with license partner Bioeq on a resubmission of the BLA for FYB201 (proposed ranibizumab biosimilar).

Bausch + Lomb enter exclusive licensing agreement

May 6, 2020

Bausch + Lomb announce it has entered into an exclusive licensing agreement with STADA and Xbrane Biopharma for the development and commercialisation of a ranibizumab biosimilar. Under the agreement, Xbrane and STADA will be jointly responsible for finalising development of the biosimilar, with Xbrane to provide commercial supply and Bausch + Lomb responsible for sales, marketing and all other commercialisation efforts.

Xbrane continues clinical trials of ranibizumab candidate

April 2, 2020

Xbrane announces it is continuing clinical trials of its ranibizumab candidate and remained on-track for target dates for regulatory filings despite CoVid-19.

UK | Filing errors ruled in a Supplementary Protection Certificate for Lucentis®

March 31, 2020

The UK High Court rules filing errors in a Supplementary Protection Certificate (SPC) for Lucentis® (ranibizumab) have cut almost two years from Roche/Genentech’s protection in the UK. These errors arose when a third party engaged by Roche/Genentech failed to pay the full lump sum fees at the start of the SPC term.

Genentech announces extended physician payment terms for Lucentis®

March 30, 2020

Genentech announces that in response to CoVid-19, it would extend physician payment terms for Lucentis® (ranibizumab) purchases to 120 days, up from the previous 60 day term. These new terms will be implemented from 01 April, 2020, as well as retroactively for Lucentis® purchased on or after March 1, 2020.

Ph III clinical trials of ranibizumab Port Delivery System commence

January 17, 2020

Genentech and Roche commence Ph III clinical trials of ranibizumab Port Delivery System (PDS) in patients with diabetic macular edema. The PDS uses a refillable eye implant to release a ranibizumab formulation over several months.

2019

US | Coherus and Bioeq obtain licensing agreement for Lucentis®

November 23, 2019

Coherus and Bioeq announce licensing agreement for Lucentis® (ranibizumab) in the US. Under the agreement, Bioeq will receive upfront and launch milestone payments, with both parties sharing the profits.

Biogen and Samsung Bioepis announce partnership for the commercialisation of ranibizumab and aflibercept

November 6, 2019

Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilars ranibizumab and aflibercept. The agreement covers the US, Canada, Europe, Japan and Australia. Under the agreement, Biogen will make one $100M upfront payment, with up to $210M payable at additional development, regulatory and sales-based milestones.

Results of study on Lucentis® with Razumab®

August 1, 2019

New study compares short-term effects of Lucentis® with biosimilar, Razumab® on vision and central foveal thickness (CFT). The study reveals that after one month,  CFT improved in 85.7% of the ranibizumab biosimilar group, and in 86.8% of the ranibizumab group.

EU | CHMP suggests additional indication of Lucentis®

July 25, 2019

Novartis announces positive CHMP opinion for additional indication of Lucentis®: the treatment of retinopathy of prematurity in preterm infants.

Xbrane Phase III trials for Xlucane® commence

April 23, 2019

Xbrane commences Phase III trials for biosimilar ranibizumab candidate Xlucane®.

Samsung Bioepis enters commercialisation partnership with C-Bridge

February 26, 2019

Samsung Bioepis partners with C-Bridge to commercialise biosimilars in China. Under the deal, C-Bridge will develop a new company, AffaMed Therapeutics to launch candidates such as ranibizumab, eculizumab and trastuzumab biosimilars.

2018

US | Xbrane submits CRA for clinical trials of Xlucane®

December 19, 2018

Xbrane submits first CTA to FDA for clinical trials of ranibizumab biosimilar candidate, Xlucane®. The Phase III trials will be conducted in patients with wet form of age-related macular degeneration.

Ranibizumab biosimilar Phase III trials announced

October 29, 2018

Samsung announces Phase III trials of ranibizumab biosimilar are underway.

Xbrane biosimilar ranibizumab results announced

October 4, 2018

Xbrane announces biosimilar ranibizumab shows equivalent pharmacokinetic profile and equivalent tolerability to originator in study conduct in rabbits.

Xbrane and STADA agreement to develop ranibizumab biosimilar

July 12, 2018

Xbrane and STADA announce they have entered into an agreement to develop a ranibizumab biosimilar for US, EU and other markets.  Under the agreement, Xbrane will be responsible for developing the product while STADA will be responsible for the marketing authorisations and sales and marketing.

Coherus announces expectation of clinical studies

May 10, 2018

Coherus announces it expects to initiate clinical studies for biosimilar ranibizumab CHS-3351 in 2018.

Results of Formycon/Bioeq Ph III studies released

May 2, 2018

Formycon/Bioeq announce interim positive results for their ph III studies for biosimilar ranibizumab FYB201.

US | Xbrane’s Phase III clinical trial for Xlucane® approved

January 18, 2018

FDA approves Xbrane’s Phase III clinical trial for a biosimilar ranibizumab candidate Xlucane®.  Xbrane expects to enrol approximately 600 patients in 16 countries with the first patient expected in March 2019.

2017

US | Formycon announces intentions to market biosimilar ranibizumab

November 28, 2017

German Formycon announced it intends to bring biosimilar ranibizumab to the US market in 2020 with commercialisation partner Bioeq (JV between Santo and Polpharma).

Pfenex ceases development of biosimilar banibizumab and pegfilgrastim

November 9, 2017

During its Q3/17 earnings update, Pfenex reports that it has ceased development of PF582 (biosimilar ranibizumab) and PF529 (biosimilar pegfilgrastim) due to resource constraints.  Pfenex reports during its Q3/17 earnings update that it has ceased development of PF582 (biosimilar ranibizumab) and PF 529 (biosimilar pegfilgrastim) due to resource constraints.

Samsung approved to commence Phase III clinical trials

September 20, 2017

Samsung is approved by the Ministry of Food and Drug Safety in South Korea to commence Phase III clinical trials for biosimilar ranibizumab.

Korean BIOCND plans completion of clinical trials

July 21, 2017

Korean BIOCND shares its plans to complete the phase 1 clinical trials of Lucentis biosimilar (BCD 300) by the end of 2017 and then will seek a partner.

2016

Pfizer and Pfenex’s partnership terminated

August 8, 2016

Pfizer terminates its relationship with Pfenex to develop PF582, biosimilar ranibizumab.

BioBlast® extract From August 8, 2016 to May 10, 2022