• Naomi Pearce & Emily Bristow

Lucentis® | Ranibizumab | Genentech

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18 Nov 2020 | All | Samsung Bioepis, Biogen | Samsung Bioepis and Biogen announce the FDA has accepted for review the BLA for SB11 (proposed ranibizumab biosimilar).

12 Nov 2020 | All | Samsung Bioepis | 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.

06 Oct 2020 | EU | Samsung Bioepis, Biogen | Samsung Bioepis and Biogen announce the European Medicines Agency has accepted for review its Marketing Authorisation Application for SB11 (proposed ranibizumab biosimilar).

05 Nov 2020 | US | Formycon, Bioeq | 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.

20 Sep 2020 | All | Regenxbio | 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.

01 Sep 2020 | All | Xbrane | Generics Bulletin 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.

28 Aug 2020 | All | 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.

11 Aug 2020 | US | Polpharma | 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.

22 Jul 2020 | All | Genentech | 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.

21 Jul 2020 | All | Novartis | Novartis releases its Q2 FY20 financial results, reporting COVID-19 negatively impacted demand for Lucentis® (ranibizumab).

18 May 2020 | All | Samsung Bioepis | 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.

15 May 2020 | All | Formycon | 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).

06 May 2020 | All | Bausch + Lomb, STADA, Xbrane | 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.

02 April 2020 | All | Xbrane Pharma | Xbrane announces it is continuing clinical trials of its ranibizumab candidate and remained on-track for target dates for regulatory filings despite CoVid-19.

30 March 2020 | All | Genentech | 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.

March 2020 | UK | Genentech/Roche | 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.

17 Jan 2020 | All | Genentech/Roche | 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.

23 Nov 2019 | US | Bioeq, Coherus BioSciences | 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.

06 Nov 2019 | All | Biogen, Samsung Bioepis | Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilar ranibizumab and aflibercept for major markets world side including the US, Canada, Europe, Japan and Australia. Biogen has also acquired exclusive commercialisation rights for its anti-TNF portfolio, including BENEPALI® (etanercept), FLIXABI® (infliximab) and IMRALDI® (adalimumab), in China. Under the agreement, Biogen will make one $100 million upfront payment, with up to $210 million payable at additional development, regulatory and sales-based milestones.

01 Aug 2019 | All | Intas Pharmaceuticals | 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.

25 Jul 2019 | EU | Novartis | Novartis announces positive CHMP opinion for additional indication of Lucentis®: the treatment of retinopathy of prematurity in preterm infants.

24 Apr 2019 | All | Xbrane Biopharma | Xbrane commences Phase III trials for biosimilar ranibizumab candidate Xlucane®.

11 Feb 2019 | CN | Samsung Bioepis & C-Bridge | Samsung Bioepis announces partnership 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.

18 Jan 2018 | US | Xbrane Biopharma | 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.

19 Dec 2018 | US | Xbrane Biopharma | 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.

29 Oct 2018 | All |Samsung Bioepis | Samsung announces Phase III trials of ranibizumab biosimilar are underway.

04 Oct 2018 | All |Xbrane Biopharma | Xbrane announces biosimilar ranibizumab shows equivalent pharmacokinetic profile and equivalent tolerability to originator in study conduct in rabbits.

12 Jul 2018 | All | Xbrane Biopharma, STADA | 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.

10 May 2018 | All | Coherus BioSciences | Coherus announces it expects to initiate clinical studies for biosimilar ranibizumab CHS-3351 in 2018.

02 May 2018 | All | Formycon/Bioeq | Formycon/Bioeq announce interim positive results for their ph III studies for biosimilar ranibizumab FYB201.

28 Nov 2017 |US| Formycon/Bioeq | German Formycon announced it intends to bring biosimilar ranibizumab to the US market in 2020 with commercialisation partner Bioeq (JV between Santo and Polpharma). Read more

09 Nov 2017 | All | Pfenex | 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. Read more

18 Sep 2017 | All | Samsung Bioepis | Samsung approved by the Ministry of Food and Drug Safety in South Korea to commence phase 3 clinical trials for biosimilar ranibizumab. Read more

Jul 2017 | All | BIOCND | 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. Read more

08 Aug 2016 | All | Pfizer | Pfizer terminates it relationship with Pfenex to develop PF582, biosimilar ranibizumab. Read more

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