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Home / News / BioBlast®

EXPLORE OUR

BioBlast®

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: ranibizumab

2024

March 11, 2024

On 11 March 2024, Formycon AG and MS Pharma announced that ranibizumab (FYB201 / Ravegza®), biosimilar to Genentech’s Lucentis®, was approved in Saudi Arabia for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases including retinopathies secondary to diabetes.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics). Teva entered into a strategic partnership for the exclusive commercialisation of FYB201 in Canada, Europe and selected other countries in mid 2021. FYB201 has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli® by Coherus) and the EU (in August 2022, marketed as Ranivisio® by Formycon). In January 20204, Sandoz announced that it had signed an agreement to acquire Coherus’ Cimerli® for US$170M.

March 4, 2024

On 4 March 2024, Sandoz announced the completion of its acquisition of biosimilar CIMERLI® (ranibizumab) from Coherus BioSciences. This VEGF inhibitor ranibizumab was approved by the FDA on 2 August 2022 and is indicated for the treatment of retinal diseases. The acquisition includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software. Sandoz announced its USD $170M deal to acquire CIMERLI® on 22 January 2024, and now reports that the deal was completed ahead of schedule.  

January 22, 2024

Sandoz announced that it has signed an agreement to acquire Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.  The deal includes the biologics license application (BLA), product inventory, ophthalmology sales and field reimbursement talent and access to proprietary commercial software.  Closing is anticipated in the first half of 2024, subject to standard conditions and approvals.

Coherus announced its sales of Cimerli® surpassed 100,000 doses in its first year in the US following launch in October 2022.

2023

December 7, 2023

Bioeq and Teva jointly announced that Health Canada granted a Notice of Compliance for Ranopto® (ranibizumab), biosimilar to Genentech’s Lucentis® (ranibizumab).  Ranopto® is indicated for the treatment of neovascular (wet) age-related macular degeneration, the treatment of visual impairment due to diabetic macular oedema or choroidal neovascularization, as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion.

FYB201/Ranopto® was developed by Bioeq (a JV between Formycon and Polpharma Biologics). Teva entered into a strategic partnership for the exclusive commercialisation of FYB201 in Canada, Europe and selected other countries in mid 2021. Following successful approvals in the UK (marketed as Ongavia® by Teva) in May 2022, as well as the US (marketed as Cimerli® by Coherus) and the EU (as Ranivisio®) in August 2022, Ranopto® is expected to launch in Canada in Q1 2024.  MS Pharma will commercialise FYB201 in the Middle East and North Africa (MENA) region following approval by the relevant regulatory authorities.

This is the third ranibizumab biosimilar approved in Canada, after Samsung Bioepis’ Byooviz® was approved in March 2022, and Roche’s Susvimo® was approved in September 2022.

November 24, 2023

Express Pharma reported that Enzene Biosciences has launched its biosimilar ranibizumab in India (biosimilar to Genentech’s Lucentis®) for the treatment of neovascular age-related macular degeneration (AMD).  This is Enzene’s seventh Indian biosimilar.

On 7 September 2023, we reported that Enzene would ‘imminently’ launch its biosimilar ranibizumab.

Enzene is on market in India for bevacizumab (biosimilar to Genentech’s Avastin®) launched 29 June 2023, adalimumab (biosimilar to AbbVie’s Humira®) launched 28 February 2023, denosumab (biosimilar to Amgen’s Xgeva®), approved 27 August 2021, romiplostim (biosimilar to Amgen’s Nplate®), approved 10 August 2021, and teriparatide (biosimilar to Eli Lily’s Forteo®), approved 4 February 2021.

November 20, 2023

CVS Caremark published its Performance Drug List for January 2024, notably removing Amgen’s Amjevita® (adalimumab), the first Humira® biosimilar launched in the US, and replacing it with Sandoz’s Hyrimoz® (adalimumab-adaz) as the preferred adalimumab product.

CVS will remove Regeneron’s Eylea® (aflibercept) and Genentech’s Lucentis® (ranibizumab), preferring either Biogen’s Byooviz® or Coherus’ Cimerli® (both ranibizumab biosimilars).  There are currently no FDA-approved aflibercept biosimilars, however on 31 October 2023 the FDA accepted Amgen’s BLA for ABP938, and on 29 August 2023 the FDA accepted Formycon’s BLA for FYB203.

CVS will de-list Sandoz’s Ziextenzo® (pegfilgrastim), biosimilar to Amgen’s Neulasta®, and prefer Amneal Bioscience’s Fylnetra® and Pfizer’s Nyvepria®.   CVS will also remove Amgen’s Kanjinti® and Pfizer’s Trazimera®, trastuzumab biosimilars to Genentech’s Herceptin®, preferring Teva’s Herzuma® or Biocon Biologics’ Ogivri®.

November 10, 2023

Lupin Limited announced that it has executed an agreement with the pharmaceutical manufacturer Amman Pharmaceuticals Industries for exclusive marketing and commercialisation of a biosimilar to Lucentis® (ranibizumab) in the middle east region, including Saudi Arabia and UAE.

October 24, 2023

FDA has approved Samsung Bioepis’ sBLA for Byooviz®, as an interchangeable biosimilar to Genentech’s Lucentis® (ranibiziumab) across all approved indications.  Byooviz® was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019 covering the US, Canada, Europe, Japan and Australia.  Byooviz® was FDA approved on 20 September 2021 and launched in the US on 2 June 2022.  FDA has approved Samsung Bioepis’ sBLA for Byooviz®, as an interchangeable biosimilar to Genentech’s Lucentis® (ranibiziumab) across all approved indications.  Byooviz® was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019 covering the US, Canada, Europe, Japan and Australia.  Byooviz® was FDA approved on 20 September 2021 and launched in the US on 2 June 2022.

October 4, 2023

Coherus BioSciences announced it has reached a significant milestone as sales of Cimerli® (ranibizumab-eqrn), a biosimilar to Genentech’s Lucentis®, exceed 100,000 doses in the first year.  Cimerli® is the first and only FDA-approved interchangeable biosimilar to Lucentis® for all approved indications.

On 5 October 2023, Coherus resubmitted its BLA to the FDA for Udenyca® OnBody™, biosimilar to Amgen’s Neulasta® after receiving CRL.

September 7, 2023

The Financial Express reported that Enzene Biosciences, subsidiary of Alkem Labs, plans to imminently launch its ranibizumab biosimilar in India. This will be Enzene’s seventh Indian biosimilar.  Enzene’s CEO confirmed that the company plans to launch two biosimilars every year.

Enzene is on market in India for bevacizumab (biosimilar to Genentech’s Avastin®) launched 29 June 2023, adalimumab (biosimilar to AbbVie’s Humira®) launched 28 February 2023, denosumab (biosimilar to Amgen’s Xgeva®), approved 27 August 2021, romiplostim (biosimilar to Amgen’s Nplate®), approved 10 August 2021, and teriparatide (biosimilar to Eli Lily’s Forteo®), approved 4 February 2021.

August 2, 2023

Coherus BioSciences announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis®, has quadrupled to $26.7M since the last quarter.  It also reported that its net revenue has risen 81% compared to the previous quarter.  Yumisry®, Coherus’s biosimilar to AbbVie’s Humira® (adalimumab) was launched in the US on 3 July.

July 25, 2023

STADA and Xbrane announced that their commercialization agreement with Bausch + Lonb has been terminated, and that they are considering options for their co-developed ranibizumab biosimilar  to Genentech’s Lucentis® (Ximluci®) in North America.

Xbrane entered into a co-development agreement with STADA Arzneimittel AG in 2018, and subsequently, in May 2020, the two companies signed an exclusive licensing agreement with Bausch + Lomb to bring the biosimilar candidate to market in the United States and Canada.

After receiving EU approval in November 2022, STADA and Xbrane intend to commercialise the product in the US.  On 22 June 2023, Xbrane announced the FDA has accepted a supplemental Biologics License Application (sBLA) for  (Ximluci®).

July 6, 2023

Biogen Canada announced that Quebec will reimburse patients receiving BYOOVIZ® (ranibizumab), biosimilar to Genentech’s Lucentis®, for certain retinal conditions such as age-related macular degeneration (AMD) in the presence of choroidal neovascularization, and visual deficiency caused by diabetic macular edema (DME).

BYOOVIZ® is the first biosimilar approved in Canada (on 2 March 2023) to treat neovascular (wet) AMD and DME.

June 21, 2023

Xbrane Biopharma announced the FDA has accepted a supplemental Biologics License Application (sBLA) for its biosimilar to Genentech’s Lucentis® (ranibizumab) to treat serious eye diseases such as wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.  The Biosimilar User Fee Amendment goal date is 21 April 2024.

Xbrane entered into a co-development agreement with STADA Arzneimittel AG in 2018, and subsequently, in May 2020, the two companies signed an exclusive licensing agreement with Bausch + Lomb to bring the biosimilar candidate to market in the United States and Canada.

On 25 April 2023, STADA and Xbrane together announced the supply of Ximluci® (ranibizumab) on the NHS in England.

May 12, 2023

A Senju study has shown that its ranibizumab biosimilar (biosim to Roche/Genentech’s Lucentis®) is more cost-effective in treat-and-extend (TAE) regimens compared to aflibercept based on higher quality-adjusted life-years (QALYs) and lower cost in treating neovascular age-related macular degeneration (nAMD).  The biosim was also cost-saving compared to Lucentis® for both TAE and pro re nata regimens. Senju’s ranibizumab biosimilar was the first ranibizumab biosim in Japan, which demonstrated comparable quality, efficacy, and safety for the treatment of nAMD.

On 25 April 2023, STADA and Xbrane announced they are supplying Ximluci® (ranibizumab) in England under a NHS England Framework Agreement.

April 25, 2023

STADA and Xbrane announced they are supplying  Ximluci® (a biosimilar to Roche/Genentech’s Lucentis® (ranibizumab)) in England under a NHS England Framework Agreement.   Ximluci® is indicated for the treatment of retinal vascular disorders, including wet age-related macular degeneration, diabetic macular oedema, diabetic retinopathy, retinal vein occlusion and visual impairment due to choroidal neovascularization.  STADA is responsible for commercializing Ximluci® across Europe and Xbrane is responsible for commercial supply.

On 3 April 2023 Stada and Xbrane announced the continental European launch of Ximluci®.

April 24, 2023

Xbrane has announced it has resubmitted its BLA for its investigational biosimilar to Genentech’s Lucentis® (ranibizumab) with FDA.  Xbrane expects that there will be a ten-month review process and its candidate could be approved during the first half of 2024.  In July 2022, Xbrane received a General Advice letter from the FDA with comments and recommendations for the resubmission of its BLA for a ranibizumab biosimilar.

April 8, 2023

A study published in Clinical Ophthalmology has found that Intas’ Razumab® (ranibizumab) biosimilar to Genentech’s Lucentis® has similar efficacy and safety in Indian patients over 50 years old for treating neovascular age-related macular degeneration (nAMD).  The study provides retrospective analysis demonstrating that Razumab® improved visual acuity and reduced central macular thickness in nAMD patients over a one-year period, with similar efficacy to Lucentis®.   This study was sponsored by Intas.

April 3, 2023

STADA announced the European launch of locally-manufactured Ximluci® (ranibizumab) biosimilar to Roche/Genentech’s Lucentis®.  Ximluci® is indicated for the treatment of visual impairment in all Lucentis® adult indications.

Ximluci® is the first product developed through a collaboration between STADA and Xbrane, and represents Xbrane’s first commercial launch.  Both companies are jointly responsible for development and manufacturing of Ximluci®, whilst STADA holds the marketing authorisations and commercial rights.

In January 2023, STADA and Xbrane announced that Ximluci® was granted marketing authorisation by the MHRA for UK supply.

March 2, 2023

Biogen Canada Inc. announced that its Lucentis® (ranibizumab) biosimilar Byooviz™ is available in Canada following approval by Health Canada for treatment of serious eye disorders including neovascular (wet) age-related macular degeneration. On 2 June 2022, Byooviz™ was launched in the US.

 
 

February 23, 2023

The Korea Herald has reported that Samsung Bioepis, through partner Biogen launched its Lucentis® (ranibizumab) biosimilar SB11 in February 2023 in Germany.   The product is sold as Byooviz™ in Europe and Ameliv™ in Korea Byooviz™ was launched in the US on 2 June 2022. 

February 16, 2023

The Paris Court of Appeal (Cour d’Appel de Paris) has overturned the anti-trust fines implemented by Autorité de la Concurrence, France’s competition commission in 2020. The French competition commission claimed that Novartis and Roche abused their dominant market position to preserve the price of Lucentis® (ranibizumab) by “colluding in obstructive behavior” and spreading “alarmist” and “misleading” statements about the risks associated with a cheaper drug Avastin® (bevacizumab). However, the Appeal Court overturned the decision, finding no cartel conduct.

Novartis says that it “strongly contested these allegations from the outset and firmly believes the company has acted appropriately and in compliance with competition law and the interests of patients at all times”.

January 16, 2023

STADA and Xbrane announced that Ximluci® (ranibizumab, biosimilar to Roche/Genentech’s Actemra®) has been granted marketing authorisation by the MHRA. Under a July 2018 agreement, STADA and Xbrane are jointly responsible for development and manufacturing of Ximluci, while STADA holds the marketing authorisations and commercial rights to the product across all territories included in the agreement.

2022

November 8, 2022

Coherus Biosciences provided a business update, announcing that Cimerli™ (biosimilar ranibizumab) has achieved leading biosimilar market share in the US within the first four weeks of launch, with 2023 net sales expected to exceed $100 million.  Coherus’ net revenue for the quarter ending September 2022 was $45.4 million, down from $82.5 million for the quarter ending September 2022.  Coherus attributed this decline to a decrease in the sales of Udencya® (pegfilgrastim biosimilar) as well as a lower net realized price due to increased competition.

September 28, 2022

A new study reported that Intas Pharmaceuticals’ Razumab® (biosimilar ranibizumab) achieved comparable visual acuity outcomes to Lucentis® in patients with polypoidal choroidal vasculopathy.

September 28, 2022

Korea Biomedical Review reported that Samsung Bioepis will present on three scientific abstracts on its ophthalmology biosimilars, aflibercept and ranibizumab, at the American Academy of Ophthalmology 2022 between 30 September – 03 October.  Samsung Bioepis reported that interim analysis of SB15 (biosimilar aflibercept) indicated an equivalence in efficacy of SB15 and Eylea® in terms of best-corrected visual acuity at 8 weeks in patients with neovascular age-related macular degeneration. This is the first time that Samsung Bioepis has disclosed data on its aflibercept biosimilar.

September 19, 2022

Coherus Biosciences announced that it will launch Cimerli™ (interchangeable biosimilar ranibizumab) in the US on 03 October 2022.  Cimerli was approved by the FDA as interchangeable with Genentech/Roche’s Lucentis® and the EMA in August 2022.

September 16, 2022

STADA and Xbrane Biopharma announced that the CHMP provided a positive opinion for Ximluci® (biosimilar ranibizumab).  If approved, ranibizumab will be the sixth biosimilar approval for STADA, following adalimumab, bevacizumab, epoetin zeta, pegfilgrastim and teriparatide.

September 6, 2022

German based biosimilars focussed company Formycon published its preliminary and unaudited financial results for the first half of 2022.  Formycon reported a turnover of Euro 17.6 million in the first six months of 2022.  The preliminary report does not include the purchase price allocation effects from the ATHOS transaction reported in May 2022 under which Formycon acquired rights to FYB202 (biosimilar Stelara®), 50% of the rights to FYB201 biosimilar Lucentis® and the operational development unit Bioeq GmbH.  Formycon has six biosimilars in development, and is also working on the development of a COVID-19 drug FYB207.

August 26, 2022

Formycon announced that the European Commission has approved Ranivisio®, biosimilar to Lucentis®/ranibizumab developed by Bioeq (which is a joint venture between Formycon and Polpharma Biologics).  Ranivisio is EC approved for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR) as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).

Earlier this month, Coherus announced the US approval of Cimerli™ with interchangeability designation, which Bioeq licensed to Coherus for the US.  The Bioeq product was also approved in the UK in May 2017 as Teva’s Ongavia®.

August 24, 2022

Samsung Bioepis’ Byooviz® (biosimilar ranibizumab) was approved in Australia for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to choroidal neovascularisation (CNV) or choroidal neovascularisation (CNV) secondary to pathologic myopia (PM), and visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).  Byooviz was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019.

Samsung Bioepis obtained marketing approval for Byooviz in the US and EU in September 2021, Canada in March 2022, and in Korea in May 2022.  It was reported in September 2021 that Samsung Bioepis took a licence for ranibizumab from Genentech from June 2022.

August 2, 2022

Coherus Biosciences announced that the FDA has approved Coherus’ Cimerli™, a biosimilar to Genentech’s Lucentis® (ranibizumab).  Cimerli is the third approved US biosimilar, but is the first to be approved for all five of Lucentis’ indications and to receive the interchangeable designation, resulting in twelve months interchangeability exclusivity.

July 4, 2022

Xbrane Biopharma confirmed that it will resubmit a BLA for its biosimilar to Lucentis® (ranibizumab) this year.  Xbrane previously announced that it would withdraw the BLA after receiving feedback from the FDA in May that additional information was required for the FDA to accept the BLA and initiate a review.

June 23, 2022

The CHMP recommended the approval of Midas Pharma’s 10mg/ml Ranivisio® (ranibizumab/biosimilar to Lucentis®) for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema or choroidal neovascularisation, and proliferative diabetic retinopathy.

June 21, 2022

Formycon published its Q1 2022 financial results, reporting sales and other earnings of EUR 8.2 million.  Formycon also announced the addition of two biosimilar projects to its pipeline, FYB208 and FYB209, for undisclosed products.  Late stage Formycon development programs include biosimilars to Lucentis® (ranibizumab), Stelara® (ustekinumab) and Eylea® (aflibercept). Formycon plans to launch its biosimilar to Lucentis® (ranibizumab) in the second half of 2022.

June 21, 2022

Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical have signed a commercialisation agreement for Amelivu®,biosimilar to Lucentis® (ranibizumab).  Under the agreement, Samil is licenced to sell Amelivu® in Korea.  Samsung Bioepis signed a settlement with Genentech in 2021 allowing it to market its ranibizumab biosimilar from June 2022.  Amelivu®/Byooviz® has been approved in the EU, US, Canada and Korea, and was launched in the US in June 2022.

June 2, 2022

Biogen and Samsung Bioepis announced the launch of Byooviz™ (biosimilar ranibizumab) in the US.  Biogen announced that Byooviz will be available at a discount of 40% compared to Lucentis®.  Byooviz was developed under a partnership between Biogen and Samsung Bioepis, and this launch is the first US biosimilar arising from the partnership.

May 17, 2022

Teva announced that the UK’s MHRA has granted marketing approval for Ongavia® (biosimilar ranibizumab), making the UK the first country in Europe to approve the product for the treatment of (wet) AMD.  Ongavia® will be Teva’s first biosimilar commercialised in Europe, and the UK’s first Lucentis® biosimilar.  The product is the result of a strategic agreement between Teva and Bioeq AG.  Ongavia® is approved for the treatment of: neovascular (wet) age-related macular degeneration; visual impairment due to diabetic macular oedema (DME); proliferative diabetic retinopathy (PDR); visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); and visual impairment due to choroidal neovascularisation (CNV).

May 16, 2022

Korea Biomedical Review reported that Samsung Bioepis has received marketing approval for Amelivu® (biosimilar ranibizumab) in Korea.  Amelivu® will be launched in Korea after June 2022 in accordance with Samsung Bioepis’ licence from Lucentis® developer Genentech.  The Korean Biomedical Review reports that Samsung Bioepis may launch in other licensed regions (which includes the USA) following “after Genentech’s SPC expires”.

May 10, 2022

Formycon and Athos KG announced closing of the acquisition by Formycon of 50% of the rights to FYB201 (biosimilar ranibizumab), 100% 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.

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.

April 4, 2022

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.

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.

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.

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.

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

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.

October 1, 2021

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

September 30, 2021

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

September 23, 2021

Korea Biomedical Review reported that Samsung Bioepis and Genetech have signed a licence agreement for ranibizumab.  Under the terms of the agreement, Samsung Bioepis can market its biosimilar ranibizumab from June 2022.

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.

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.

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.

August 5, 2021

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

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.

July 6, 2021

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

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.

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.

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.

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).

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.

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.

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

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.

November 18, 2020

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

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.

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).

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.

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.

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.

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.

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.

July 21, 2020

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

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.

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).

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.

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.

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.

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.

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

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.

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.

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.

July 25, 2019

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

April 23, 2019

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

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

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.

October 29, 2018

Samsung announces Phase III trials of ranibizumab biosimilar are underway.

October 4, 2018

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

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.

May 10, 2018

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

May 2, 2018

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

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

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).

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.

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.

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

August 8, 2016

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

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