BioBlast®

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 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.

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 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.

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 6^th 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.

The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10^th 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 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.

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.

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

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

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 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.

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.

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

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.

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

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.

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 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.

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.

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 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.

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.

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.

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

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.

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.

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

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.

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.

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.

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

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.

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

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 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.

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.

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 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.

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.

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

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

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.

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.

Samsung announces Phase III trials of ranibizumab biosimilar are underway.

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

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

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

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.

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

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

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.

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