Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
PipCast®
PTE
Trade Marks
Webinars

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: aflibercept

2024

February 26, 2024

On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of Food and Drug Safety for Afilivu®, biosimilar to Regeneron’s Eylea® (aflibercept).  This is the first aflibercept biosimilar approved in Korea and Samsung Bioepis’ second biosimilar for ophthalmic disease, after its Lucentis® (ranibizumab) biosimilar – Amelivu® – was approved in Korea in May 2022.  Afilivu® is indicated for treatment of wAMD, RVO, DME and mCNV.   

As previously reported, Samsung Bioepis will co-market Afilivu® in Korea with Samil Pharmaceutical, together with ranibizumab biosimilar Amelivu®. 

In the US, aflibercept biosimilars are the subject of patent infringement litigation commenced by Regeneron against Samsung Bioepis, Amgen, Formycon, Celltrion and Mylan and Biocon.  In Europe, Formycon announced in December 2023 that the EMA had accepted its marketing authorisation application for its aflibercept biosimilar FYB203. Biocon has received marketing approval for its aflibercept biosimilar Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). Formycon announced in December 2023 that the EMA had accepted its application for its aflibercept biosimilar FYB203. 

February 19, 2024

According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement.  The applications for PBS listing additions or amendments that the PBAC will consider at its March 2024 meeting include the following: 

New Listings  Amendment Applications  
Janssen-Cilag’s Stelara® (ustekinumab)  Sanofi-Aventis’s Dupixent® (dupilumab) 
Amgen’s Wezlana® (ustekinumab)  Bristol-Myers Squibb’s Opdivo® (nivolumab) 
Bayer’s Eylea® (aflibercept)  Merck’s Erbitux® (cetuximab) 
AstraZeneca’s Enhertu® (trastuzumab deruxtecan)  AbbVie’s Humira® (adalimumab) 
Celltrion’s Vegzelma® (bevacizumab)   
Celltrion’s Yuflyma® (adalimumab)   
AstraZeneca’s Saphnelo® (anifrolumab)   
Roche’s Tecentriq® (atezolizumab)   
UCB’s Bimzelx® (bimekizumab)   

 

 

 

 

 

 

 

In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to AbbVie’s Skyrizi® (risankizumab), and Novartis’s Cosentyx® (secukinumab). 

February 13, 2024

A study sponsored by Qilu Pharmaceutical, published in Ophthalmology and Therapy reports that, in a Chinese, randomised, double-blind, phase III trial, Qilu’s QL1207 was equivalent to Regeneron’s Eylea® for neovascular age-related macular degeneration, with similar safety profiles.   

According to the study, QL1207 is the first aflibercept biosimilar developed in China.  

February 1, 2024

Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical will co-market SB15, Samsung’s biosimilar of Regeneron’s Eylea® (aflibercept) in Korea.  The agreement intends to utilise Samsung’s R&D capabilities with Samil Pharmaceuticals’ sales and marketing expertise.

On 21 June 2022, Samsung Bioepis and Samil also entered a commercialisation agreement for Amelivu®, a biosimilar to Genentech’s Lucentis® (ranibizumab).

January 31, 2024

On 31 January 2024, the US District Court for the Northern District of West Virginia published a redacted version of Judge Thomas Kleeh’s Memorandum Opinion and Order, setting out the detailed reasons for his previous finding that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®.  The Judge found asserted claims of two method of treatment patents (11,253,572 and 10,880,601) to be invalid.   

The infringement finding was made in relation to the aflibercept biosimilar Yesafili®.  Mylan filed a Biologics Licence Application (BLA) for Yesafili® in October 2021 seeking FDA approval to market it.  Mylan’s rights in the Yesafili® BLA were later transferred to Biocon, who intended to sell the product in the US. 

On 27 December 2023, Judge Kleeh issued a short-form judgment setting out his conclusions.  At that time, the detailed reasons remained under seal.  Mylan and Biocon and Regeneron filed “protective” notices of appeal from the short form judgment on 26 January 2024, although the parties allege that the 27 December judgment was not a final, appealable one. 

Biocon has received marketing approval for Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). 

January 24, 2024

Marketscreener reported that Bayer’s application for regulatory approval of Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) has been accepted by the Chinese National Medical Products Administration (NMPA) for review.

On 19 January 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Bayer’s Eylea® 8mg to treat nAMD and visual impairment due to diabetic macular oedema (DMO).

January 19, 2024

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bayer’s Eylea®8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).

Eylea® 8mg was approved in Japan on 18 January 2023, and in Europe on 8 January 2024, for nAMD and DMO.  On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.

January 18, 2024

Bayer announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted market authorisation (MA) for Eylea® 8 mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO).  The approval was based on studies comparing Eylea® 8mg dosed at 12 or 16 week intervals compared to Eylea® 2mg dosed at 8 week intervals, following initial monthly doses.  Eylea® 8 mg is jointly developed by Bayer and Regeneron.  Regeneron maintains exclusive rights to Eylea® (aflibercept 2 mg) and Eylea® HD (8mg) in the US.  Bayer is the licensee of exclusive marketing rights outside the US.

On 8 January 2024, Bayer received MA from the European Commission for Eylea® 8mg for the same indications as Japan.  On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.

January 10, 2024

Regeneron filed a Compliant in the US District Court for the Central District of California against Amgen asserting infringement of 32 aflibercept patents.  The Complaint states that on 31 October 2023, Amgen announced that the FDA accepted its abbreviated Biologics Drug Application (aBLA) for ABP938, Amgen’s biosimilar to Regeneron’s Eylea® (aflibercept). Regeneron is seeking a preliminary and permanent injunction against Amgen, a finding of willful infringement, damages (including enhanced damages for wilful infringement) and costs.

Regeneron filed its fourth aflibercept complaint in the US District Court for the Northern District of West Virginia against Formycon on 29 November 2023.  Regeneron has also sued Samsung Bioepis (on 21 November 2023), Celltrion (on 8 November 2023) and Mylan (on 3 August 2022) over their respective aflibercept biosimilars.

January 9, 2024

The Patent Trial and Appeal Board (PTAB) in found that Regeneron’s patents 10,130,681 and 10,888,601 relating to methods of treatment using Eylea® (aflibercept) are invalid.  The PTAB held in IPR2022-01225 and IPR2022-01226 that all challenged claims of the two patents were anticipated by a journal publication which disclosed aflibercept for age-related macular degeneration (AMD), and disclosed phase I and II data relating to its use in neovascular AMD.  The inter partes review (IPR) proceedings were filed by Mylan in July 2022 and instituted in January 2023.

On 23 March 2023, PTAB instituted Celltrion’s IPR challenge to ‘601 and ’681 and Samsung Bioepis’ IPR challenge to ‘601.  PTAB also granted Celltrion and Samsung Bioepis’ motions to join the Mylan IPRs. Samsung Bioepis’ IPR2023-00442 challenge to the ‘681 patent is still pending before the PTAB.

 

 

January 8, 2024

Bayer announced that the European Commission (EC) granted marketing authorisation (MA) for Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).  Eylea® 8 mg is approved for administration at extended treatment intervals of up to every four months, following three initial monthly doses, and in patients with stable visual outcomes intervals of up to five months may be considered.  Eylea® 8 mg is the only treatment in the EU approved for extended treatment intervals of up to five months in nAMD and DMO.

Eylea® 8 mg is jointly developed by Bayer and Regeneron.  Regeneron maintains exclusive rights to Eylea® (aflibercept 2 mg) and Eylea® HD (8mg) in the US.  Bayer has licensed the exclusive marketing rights outside the US.

On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.  The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the 8mg Eylea® for the treatment of nAMD and DMO in November 2023, however Eylea® is not approved for diabetic retinopathy in the EU.

January 4, 2024

Samsung Bioepis, Celltrion and Formycon have filed responses to Regeneron’s Motion for Alternative Service in each of their respective matters before the United States District Court for Northern District Of West Virginia regarding biosimilars to Eylea® (aflibercept).  Regeneron has sought authorisation to serve Samsung Bioepis, Celltrion and Formycon by email to their respective US counsel.  All three defendants submit that they intend to file motions to dismiss their matters for lack of personal jurisdiction, without waiting for service, rendering the issue of service moot.

On 27 December 2023, the US District Court for the Northern District of West Virginia found that Mylan infringed or induced infringement of three Regeneron Eylea® (aflibercept) patents, with two of those patents were invalid for obviousness.

January 3, 2024

Alvotech announced positive top-line results for AVT06, its biosimilar to Regeneron’s Eylea® (aflibercept).   The study was a randomised, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea® in patients with neovascular (wet) age-related macular degeneration.  The study met its primary endpoint, with results demonstrating therapeutic equivalence between AVT06 and Eylea®.

In May 2023, Alvotech and Polifarma announced an exclusive commercialisation agreement for AVT06 in Turkey.

2023

December 27, 2023

Regeneron filed a complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting 51 counts of patent infringement.  This is the second suit filed against Samsung Bioepis in the Regeneron aflibercept matters, the first of which was filed on 21 November 2023.  

Samsung has filed IPR petitions against a number of Regeneron aflibercept patents including  US10,464,992 on 18 August 2023, relating to formulations of aflibercept, and method of treatment patents US11,253,572 on April 2023, US10,888,601 on April 2023 and US10,130,681 on January 2023. 

December 27, 2023

Judge Thomas Kleeh of the US District Court for the Northern District of West Virginia has found that Mylan infringed or induced infringement of three Regeneron Eylea® (aflibercept) patents.  The Court published a short form judgment and concluded that:

  • Mylan infringed claims 4, 7, 9, 11, 14, 15, 16, and 17 of the formulation patent no. 11,084,865;
  • Mylan would induce infringement of claims 6 and 25 of method of treatment patent no. 11,253,572 and claims 11 and 19 of patent no. 10,888,601;
  • the relevant claims of ‘865 were valid (Mylan’s arguments they were invalid for lack of novelty, inventive step, written description, enablement or indefiniteness failed);
  • claims 6 and 25 of ‘572 and claims 11 and 19 of ‘601 lacked inventive step.

The valid ‘865 patent expires in the US on 14 June 2027.  Detailed reasons for the findings are under seal.  Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea®.  On 27 April 2023, Regeneron filed a stipulation to narrow the case to the above three patents.  Regeneron’s Complaint asserts that the FDA notified Mylan of acceptance of its aBLA on 28 December 2021.

December 27, 2023

Formycon announced that the European Medicines Agency (EMA) accepted its marketing authorisation application (MAA) for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).

On 29 November 2023, Regeneron sued Formycon in the US for infringement of 39 of its Eylea® patents.

December 19, 2023

A Samsung Bioepis study published in BMJ Open Ophthalmology demonstrated that SB15, its biosimilar to Regeneron’s Eylea® (aflibercept), had comparable efficacy, safety, pharmacokinetics and immunogenicity to Eylea® up to week 56 in patients with neovascular age- related macular degeneration  (nAMD).  The study also showed that switching from Eylea® to SB15 maintained comparable clinical efficacy and safety.  The authors claim that the results support biosimilarity between SB15 and Eylea®.

Samsung Bioepis announced the phase III switching study results for SB15 on 7 October 2023.

December 18, 2023

Korea Biomed reported that the Ministry of Food and Drug Safety (MFDS) has imposed a six week suspension of Samsung Bioepis’ completed clinical trials of SB15, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the report Samsung Bioepis altered the approved validity period of the clinical trial drugs without obtaining approval from the MFDS, and deviated from the approved labelling requirements.  The MFDS confirmed Samsung breached the Pharmaceutical Affairs Act and invoked a suspension of the clinical trial until 2 February 2024, despite the clinical trials having already concluded.

On 7 October 2023, Samsung Bioepis announced its Phase III switching study results for SB15 which confirmed interchangeability and biosimilarity with Eylea®.

December 14, 2023

Celltrion filed an inter partes review (IPR) petition challenging Regeneron’s Eylea® aflibercept  patent no. 11,253,572, in IPR proceeding IPR2024-00260.  Celltrion also filed a motion for joinder with Samsung Bioepis’ IPR (IPR2023-00884) of the ‘572 patent which was instituted in November 2023.  The ‘572 patent relates to methods of use of aflibercept in treating angiogenic eye disorders.

December 8, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) petition challenging Regeneron’s Eylea® (aflibercept) patent no. 10,464,992 in IPR proceeding IPR2023-01312.  The patent claims formulations of aflibercept suitable for intravitreal injection.  Samsung Bioepis also successfully filed a Motion for Joinder requesting to join the proceeding with IPR2023-00462, in which PTAB instituted Celltrion’s IPR against the ‘992 patent.

On 18 August 2023 Samsung Bioepis filed an IPR petition against ‘992 and sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

November 29, 2023

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Formycon asserting infringement of 39 US aflibercept patents.  The heavily redacted Complaint states that on 29 August 2023 Formycon announced its aBLA for FYB203 was accepted for review by the FDA, and that this constitutes patent infringement.  The Complaint also states on information and belief that on 30 August 2020 Formycon imported or directed the importation at least one shipment of FYB203 into the US.

This is Regeneron’s fourth aflibercept complaint filed in the US District Court for the Northern District of West Virginia.  Regeneron has also sued Samsung Bioepis (on 21 November 2023), Celltrion (on 8 November 2023) and Mylan (on 3 August 2022) over their respective aflibercept biosimilars.

November 27, 2023

Formycon AG and Klinge Biopharma GmbH announced that they have applied to the European Medicines Agency (EMA) for marketing authorisation in the EU for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).

Only a few days before on 24 November 2023, Celltrion announced it also applied for EU approval of its aflibercept biosimilar CT-P43.  On 29 August 2023, the FDA accepted Formycon’s BLA for FYB203, its biosimilar to Eylea®.

November 24, 2023

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has applied for marketing authorisation in the EU for its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) on 23 November 2023.  The application is based on the positive results from Celltrion’s Ph III trials of CT-P42 which were reported on 3 April 2023.

November 21, 2023

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting infringement of 37 US aflibercept patents.  The heavily redacted Complaint does not disclose any information about Samsung’s abbreviated Biologics Drug Application (aBLA) for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), an intravitreal treatment for age-related macular degeneration and other VEGF-mediated eye conditions.  However, the Complaint states on information and belief that between 2 July 2019 and 8 June 2023 Samsung entities imported or directed the importation into the US of 36 shipments of SB15.

Samsung has filed IPR petitions against a number of Regeneron aflibercept patents: US10,464,992 on 18 August 2023, relating to formulations of aflibercept, and method of treatment patents US11,253,572 in April 2023, US10,888,601 in April 2023 and US10,130,681 in January 2023.

November 20, 2023

Biocon Biologics filed an Inter Partes Review (IPR) petition against  certain claims of Regeneron’s US patent no. 10,888,601 relating to Eylea® (aflibercept).  The challenged claims relate to methods of treating diabetic macular edema and diabetic retinopathy.  Biocon Biologics’ petition asserts the same grounds as the earlier petition filed by Samsung Bioepis and instituted by the USPTO Patent Trial and Appeal Board (PTAB) in March 2023, and includes a motion for joinder with Samsung’s petition.

November 20, 2023

Sam Chun Dang Pharmaceutical announced in a corporate filing that it has signed an exclusive 10-year distribution agreement with an unnamed distributor regarding SCD411, biosimilar to Regeneron’s Eylea® (aflibercept), to be supplied to Austria, Germany, Italy, Spain and Switzerland.  Sam Chun Dang will receive up to €20M from the unnamed distributor, with the agreement implementing a 50% profit share arrangement.

On 24 August 2023, Sam Chun Dang licenced SCD411 to Apotex for Canada.

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 17, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) against Regeneron’s Eylea® (aflibercept) patent no. 11,253,572 in IPR proceeding IPR2023-00884.  The ‘572 patent relates to methods of use of aflibercept in treating angiogenic eye disorders.

On 18 August 2023 Samsung Bioepis filed an IPR petition against Regeneron’s Eylea® patent no. 10,464,992 and sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

November 13, 2023

Biocon Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), to treat neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation This follows the 20 September 2023EC marketing approval Biocon Biologics secured for Yesafili®. 

November 10, 2023

Bayer announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 8mg Eylea® (aflibercept) intravitreal injection for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), with treatment intervals of up to five months.

The US FDA approved 8mg Eylea® in August 2023.

Aflibercept 8 mg was jointly developed by Bayer and Regeneron.  Bayer reported that Regeneron has exclusive rights to Eylea 2mg and 8mg in the US, and Bayer has the exclusive marketing rights outside the US.

November 8, 2023

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Celltrion asserting infringement of 38 US aflibercept patents.  The allegations relate to Celltrion’s abbreviated Biologics Drug Application (aBLA) filed with the US Food and Drug Administration (FDA) on 30 June 2023 for CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept), an intravitreal treatment for age-related macular degeneration and other VEGF-mediated eye conditions.

The Complaint states that Celltrion has served a Notice of Commercial Marketing and that its aBLA may be approved as soon as 18 May 2024, the regulatory exclusivity expiry date for Regeneron’s Eylea®.

In March, the US PTAB instituted Celltrion’s IPR challenges to two of these patents, US 10,888,601 and US 10,130,681.

October 31, 2023

Amgen announced in its Q3 2023 results that the FDA has accepted its Biologics License Application (BLA) for ABP 938, its biosimilar to Regeneron’s Eylea® (aflibercept).  Amgen did not include the FDA target action date in its announcement.

On 29 August 2023, the FDA accepted Formycon’s BLA for FYB203, its biosimilar to Eylea®.

October 27, 2023

Roche announced that the FDA has approved Vabysmo® (faricimab) to treat a new indication: macular oedema following retinal vein occlusion.  The clinical trials demonstrated non inferiority against aflibercept (marketed by Bayer/Regeneron’s as Eylea®).  The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023, which is its third approved indication.

Vabysmo® was first FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.  Vabysmo® was first  FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.

October 20, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) against Regeneron’s Eylea® (aflibercept) patent no. 10,888,601 in IPR proceeding IPR2023-00739.  The ‘601 patent relates to methods of use of aflibercept in treating age related macular degeneration, diabetic macular oedema, diabetic retinopathy and angiogenic eye disorders.

On 18 August 2023 Samsung Bioepis filed an IPR petition against Regeneron’s Eylea® patent no. 10,464,992 and sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

October 7, 2023

Samsung Bioepis announced its Phase III switching study results for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), at EURETINA 2023.  The results comparable clinical efficacy when switching to SB15 from Eylea® for patients with neovascular age-related macular degeneration (nAMD), confirming interchangeability and biosimilarity.

On 8 June 2023, JAMA Ophthalmology published the Ph III trial results for SB15, and demonstrating equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to Eylea® in participants with nAMD.  In April 2023, Samsung Bioepis announced 1-year outcomes of its Ph III study at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

September 20, 2023

Biocon Biologics announced that Yesafili®, its biosimilar to Regeneron’s Eylea® (aflibercept), has received marketing approval from the European Commission (EC).  It was approved to treat various ophthalmic conditions such neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

This approval follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)  positive opinion for Yesafili® on 21 July 2023.

August 29, 2023

Formycon and Klinge Biopharma announced that the FDA has accepted for review the BLA for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).  The FDA has assigned a target action date of June 2024.

Formycon submitted the BLA for FYB203 in June 2023.  FYB203 is being developed by Formycon and will be commercialised by Klinge Biopharma.

August 24, 2023

Korea Biomedical Review reported that Sam Chun Dang Pharm has licensed its aflibercept biosimilar to Apotex for Canada.  Under the agreement, Sam Chun Dang Pharmaceutical will receive an upfront payment of approximately 4 billion South Korean won.  Additionally, Sam Chun Dang Pharmaceutical expects to receive up to 50% of the gross profit if the PFS product is the first to be listed on drug coverage plans, or if it is listed within three months of the first biosimilar aflibercept PFS product.  If the product is listed within 4-6 months of other biosimilar aflibercept PFS products, Sam Chun Dang will receive 35% of the gross profit.

August 18, 2023

Regeneron announced that the FDA approved its 8mg Eylea® (aflibercept) to treat Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR).  The 8mg dose is the only treatment approved in wAMD and DME for immediate dosing at 8-week and up to 16-week intervals following three initial monthly doses.

On 10 August 2023, Regeneron announced the results of two-year (96 week) data from its PULSAR trials investigating aflibercept 8mg in wet age-related macular degeneration.  In June 2023 Regeneron announced that the FDA had issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.

August 18, 2023

Samsung Bioepis filed an IPR petition against Regeneron’s US10,464,992 relating to formulations of aflibercept.  Samsung Bioepis has sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

Samsung Bioepis has previously filed petitions against Regeneron’s method of treatment patent US11,253,572 in April 2023 and US10,888,601 in April 2023, with a third IPR previously filed against a third method of treatment patent US10,130,681 in January 2023.

August 15, 2023

Sandoz published the results from MYLIGHT Ph III trials of its biosimilar aflibercept in patients with wet macular degeneration.  Sandoz reported that the study met its primary efficacy endpoint and showed no clinically meaningful differences to Regeneron’s Eylea®.  Sandoz commenced the MYLIGHT trials in May 2021 and expects to file for regulatory approval for its biosimilar aflibercept in the EU and US in the coming months.

On 18 August 2023, Novartis issued an invitation to an Extraordinary General Meeting (EGM) of Novartis shareholders on 15 September 2023 to vote on the approach to the proposed spin-off of Sandoz.

August 10, 2023

On 10 August 2023, Regeneron announced the results of two-year (96 week) data from its PULSAR trials investigating aflibercept 8mg in wet age-related macular degeneration.  Regeneron reported that aflibercept 8mg demonstrated durable vision gains at extended dosing intervals (including intervals greater than 12 weeks) and that the safety of aflibercept 8mg remained consistent with the known safety profile of Eylea®.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.  In June 2023 Regeneron announced that the FDA had issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.

August 8, 2023

Regeneron filed an unopposed motion to terminate IPR2023-00620 after disclaiming all claims of the US process patent no 10,406,226. Celltrion filed the IPR in February 2023, and it had not yet been instituted by the PTAB.  All claims of the ‘226 patent relate to a method of making a VEGF antagonist fusion protein involving expressing the fusion protein in CHO, purifying the fusion proteins such that a defined percentage is not an aggregate.

The results of Celltrion’s Ph III trials of CT-P42 were reported on 3 April 2023.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®.  On 30 June 2023, Celltrion filed an NDA for CT-P42 with the FDA, and  announced that it intends to file an ABLA in at least the US and Europe later in 2023.

July 26, 2023

According to the Korea Biomedical Review Celltrion has applied to the Ministry of Food and Drug Safety for marketing authorisation of its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) for all of Eylea®’s indications approved in Korea, including wet age-related macular degeneration and diabetic macular edema.

Celltrion announced the results of its Ph III trials of CT-P42 on 3 April 2023 which demonstrated equivalence and similarity to Eylea®.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®.

On 30 June 2023, Celltrion filed an NDA for CT-P42 with the FDA, and  announced that it intends to file an ABLA in at least the US and Europe later in 2023.

July 21, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for three biosimilars:

  • Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra®. Tyenne® is intended for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19. Tyenne is the first biosimilar for this active substance.
  • Sandoz’s Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®.  Tyruko® is intended to treat active relapsing remitting multiple sclerosis.
  • BGP Pharma’s Yesafili® (aflibercept), a biosimilar to Regeneron’s Eylea®. It is intended to treat age-related macular degeneration

To obtain approval in Europe, the European Commission needs to approve the above positive recommendations from the CHMP.

During this same July 2023 CHMP meeting, the CHMP also issued a positive opinion for BMS’s Opdivo® (nivolumab) to treat completely resected stage IIB or IIC melanoma and Merck’s Keytruda® (pembrolizumab) to treat HER2-Positive Advanced Gastric or Gastroesophageal Junction.

June 30, 2023

The Korea Biomedical Review reported that Celltrion has filed an NDA with the FDA for CT-P42 (aflibercept), biosimilar to Regeneron’s Eylea®.  Based on its phase III trials which demonstrated equivalence and similarity to Eylea®, Celltrion is seeking approval for all adult indications (including wet age-related macular degeneration and diabetic macular edema).  Celltrion will seek marketing authorisation for CT-P42 in key markets including Europe.

June 29, 2023

Formycon and Klinge Biopharma announced that its BLA for FYB203 (biosimilar to Regeneron’s Eylea® aflibercept) has been submitted to the FDA. A response from the FDA is expected by the end of August 2023.  FYB203 is being developed by Formycon, and will be commercialised by Klinge Biopharma.

June 28, 2023

Bloomberg reported that the Complete Response Letter (CRL) issued by the FDA in relation to Regeneron’s BLA for aflibercept 8mg identified deficiencies at Catalent Inc.’s facility in Bloomington, Indiana.  On 27 June 2023, Regeneron announced that that the FDA had issued a CRL in relation to inspection findings at a third-party filler, and that no issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.

June 27, 2023

Regeneron announced that the FDA has issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.  Aflibercept 8mg is being jointly developed by Regeneron and Bayer AG as a higher dose formulation of aflibercept (compared to the currently approved 2mg Eylea®) with the aim of extending treatment intervals.

Regeneron reported that the CRL was issued in relation to inspection findings at a third-party filler, and that no issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL.  Regeneron reported that it will work with the FDA and the third-party filler to obtain approval as soon as possible.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.

June 8, 2023

JAMA Ophthalmology published the results of Ph III trials of Samsung Bioepis’ SB15 (aflibercept biosimilar).  Researchers reported that SB15 showed equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to reference aflibercept in participants with neovascular age-related macular degeneration.  In April 2023, Samsung Bioepis announced 1-year outcomes of its Ph III study of SB15 at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

May 23, 2023

Amgen filed a motion to intervene in the proceedings on foot between Regeneron and Mylan in West Virginia relating to aflibercept, and has sought to unseal certain documents. Amgen argued that the sealing of the documents blocked the public’s right of access to Court documents, and that the Court has provided no justification for sealing a number of documents.

Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea (including the ‘601 patent), and a 10 day trial has been set down for June 2023, which is 10 months after Regeneron filed its complaint.

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.

May 10, 2023

Alvotech announced that an exclusive agreement with Polifarma for the commercialisation of AVT06 (aflibercept, biosimilar to Bayer/Regeneron’s Eylea®) in Turkey.  Alvotech announced the initiation of ALVOEYE clinical trials for AVT06 in July 2022 in (wet) age-related maculation degeneration (AMD).

May 4, 2023

Regeneron published its Q1 2023 financial results, reporting a 5% drop in US Eylea® sales from the previous quarter. The FDA accepted for priority review Regeneron’s BLA for higher dose aflibercept 8mg for treatment of patients with wet age-related macular degeneration in February 2023, with a target action date of 27 June 2023.

April 27, 2023

Samsung Bioepis filed an IPR petition against Regeneron’s US patent no. 11,253,572directed to methods of treating an angiogenic eye disorder by intravitreal injection of aflibercept via a specified dosage regime, with a specified result.

Apotex (unsuccessfully) filed an IPR against claims 1-14 of the Patent on 10 March 2023, as the PTAB denied institution of Apotex’ petition in March 2023.  Conversely, Samsung is challenging all 30 claims of the Patent.   Samsung argues that a number of the claims are anticipated by press releases and a peer reviewed publication pertaining to phase III clinical trials for aflibercept.  It is also arguing that various claims are invalid for obviousness in light of those disclosures.

This comes only two days after Samsung released its new phase III trial data for its aflibercept (Eylea®) biosimilar.

April 26, 2023

Regeneron listed additional aflibercept patents on the Purple Book patent list.  The Purple Book patent list records the patents exchanged between the originator and biosimilar applicant as part of the patent dance and suggests that another dance has begun with a second biosimilar applicant. There are now 46 aflibercept patents listed on the Purple Book, including the 24 asserted against Mylan in August 2022. 

April 25, 2023

Samsung Bioepis announced 1-year outcomes of its Ph III study of SB15 (biosimilar to Eylea® aflibercept) at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.  Samsung Bioepis reported that the safety, immunogenicity and PK profiles of SB15 were comparable with those of aflibercept, and that no treatment-induced or treatment-boosted anti-drug antibodies developed in the switching group after week 32.

April 20, 2023

Samsung Bioepis announced that it will present new data on its SB15 (proposed aflibercept biosimilar) at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, on 23 and 24 April 2023, including 56-week results from its Ph III trials.

Samsung Bioepis and Biogen announced a partnership for the commercialisation of aflibercept and ranibizumab biosimilars in November 2019.

April 19, 2023

The US District Court of West Virginia has issued a claim construction order pertaining to seven claims of the four patents asserted in Regeneron’s BPCIA case against Mylan.  The four patents in suit (US Patent Nos. 10,888,601, 11,084,865, 11,253,572, and 11,104,715) are directed to Regeneron’s Eylea® (aflibercept).  The Court only adopted one of Regeneron’s proposed constructions of the terms, and adopted the remaining six terms as proposed by Mylan.  On 20 April 2023, Mylan sought summary judgment of non-infringement or invalidity of particular claims in the above four patents.  The case is set down for an expedited two-week trial beginning 12 June 2023.

April 14, 2023

The District Court of West Virginia denied Mylan’s emergency motion seeking orders which would require Regeneron to immediately narrow the scope of its infringement proceedings to 12 claims of 3 patents. As it currently stands, Regeneron is required to narrow the scope of the proceedings within seven days of the court making its Markman order, or seven days after the close of fact discovery, whatever is later.  The Court found that Mylan had not shown good cause for an emergency order status or a modification of the scheduling order.

Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea®, and a 10 day trial has been set down for June 2023, which is 10 months after Regeneron filed its complaint.

April 3, 2023

Korea Biomedical Review reported that the 24 week results from Celltrion’s Ph III trials of CT-P42 (aflibercept) demonstrate equivalence and similarity to Regeneron’s Eylea®.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®.  Celltrion intends to file an ABLA for CT-P42 in at least the US and Europe later in 2023.

We have previously reported on the Celltrion IPR challenges to Regeneron’s key aflibercept patents in the US.

March 22, 2023

PTAB instituted Celltrion’s IPR challenges to US 10,888,601 (decision here) and US 10,130,681 (decision here) and Samsung Bioepis’ IPR challenge to US 10,888,601 (decision here).  PTAB also granted Celltrion and Samsung Bioepis’ motions to join these IPRs with the earlier IPRs filed against the same Regeneron patents by Mylan in July 2022 which were instituted in January 2023.  Celltrion and Samsung Bioepis sought to join the Mylan IPRs in February 2023.

Note:

March 13, 2023

Luye Pharma Group announced that it has completed patient enrolment in Ph III trials of BA9101 (also known as OT-702), biosimilar to Regeneron’s aflibercept/Eylea®.  BA9101 was developed by Luye Pharma’s subsidiary Boan Biotech with clinical studies being conducted in conjunction with Boan’s partner Ocumension Therapeutics under an agreement announced in October 2020.

March 10, 2023

PTAB denied institution of the IPR filed by Apotex against Regeneron’s 11,253,572 patent relating to a method of treating an angiogenic eye disorder by administering a VEGF antagonist, including Eylea® (aflibercept).  Apotex filed the IPR in September 2022, challenging claims 1-5, 8-11, 14 and 26 for anticipation and 6, 7, 12 and 13 for obviousness.  PTAB found that Apotex had not demonstrated a reasonable likelihood that it would prevail in showing that any of the challenged claims of the ‘572 patent is unpatentable.

The ‘572 patent is one of the 24 patents included in the Regeneron suit against Mylan in West Virginia, filed in August 2022, and one of the six patents chosen by Regeneron to be determined at a 10 day trial in June 2023, 10 months after Regeneron filed its complaint.  No other application for IPR has been filed to date against the ‘572 patent, although there are currently 7 other applications against 3 patents pending: 10,130,681 (filed by Mylan, Celltrion and Samsung Bioepis), 10,888,601 (filed by Mylan, Celltrion and Samsung Bioepis) and 10,464,992 (filed by Celltrion).  Institution of Mylan’s challenge to 10,857,205 was recently denied after Regeneron disclaimed all claims of the patent. Last year PTAB invalidated Regeneron’s 9,254,338 and 9,669,069 for anticipation based on Mylan’s application for IPR.

In December 2022, we reported on Ontario’s biosimilar switching program which required patients to be transitioned to biosimilars (including infliximab) by 29 December 2023.

March 1, 2023

PTAB denied institution of Mylan’s IPR challenge to US10,857,205 (relating to Regeneron’s Eylea® aflibercept), after Regeneron filed a disclaimer with the USPTO, disclaiming all claims of the patent  

February 28, 2023

Celltrion filed an application for inter-partes review (IPR) against a fourth Regeneron US patent 10,406,226 relating to a method of making a VEGF antagonist fusion protein, including the fusion protein aflibercept supplied by Regeneron as Eylea®.    

Celltrion previously filed IPRs against Regeneron’s method of treatment patents 10,888,601 and 10,130,681 patents on 10 February 2023, as did Viatris (Mylan) on 11 January 2023 and Samsung Bioepis on 10 February 2023 and 6 January 2023 respectively.  Last month Celltrion and Samsung Bioepis separately sought joinder of their challenges to Regeneron’s ’601 and ’681 patents with Viatris’ IPR against the ‘601 and ‘681 patents, which were instituted in January 2023 

The Regeneron suit against Mylan in West Virginia, filed in August 2022, includes each of the ‘601, ‘681 and ‘226 patents.  The ‘601 patent is one of the six patents chosen by Regeneron to be determined at a 10 day trial in June 2023, 10 months after Regeneron filed its complaint.  

February 23, 2023

Regeneron announced that the FDA has accepted for priority review its BLA for aflibercept 8mg for treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.  The BLA was supported by two pivotal trials demonstrating non-inferior vision gains to EYLEA® (aflibercept) Injection, with vast majority of patients maintaining extended dosing regimens through 48 weeks.  The FDA target action date is 27 June 2023. Aflibercept 8mg is being jointly developed by Regeneron and Bayer A.G.

February 22, 2023

South Korea’s Alteogen announced that its subsidiary Altos Biologics has completed patient enrolment in its Ph III trials of ALT-L9 aflibercept (biosimilar to Regeneron’s Eylea®) in patients with neovascular  age-related macular degeneration.  Alteogen reported that it plans to submit the BLA in early 2024, with a European launch anticipated in the first half of 2025.

February 10, 2023

Celltrion and Samsung Bioepis each filed motions seeking joinder of their respective IPR challenges to Regeneron’s 10,888,601 and 10,130,681 patents for Eylea® (aflibercept) with Mylan’s, which was instituted in January 2023.

PTAB also instituted Mylan’s IPR against Regeneron’s US10,130,681.   A third Mylan IPR challenge against US10,857,205 remains pending and is likely to be initiated in April 2023.

Separately, Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea (including the ‘601 patent), and a 10 day trial has been set down for June 2023, which is 10 months after Regeneron filed its complaint.

February 10, 2023

Samsung Bioepis filed a petition for inter partes review of Regeneron’s US 10,888,601, relating to Eylea® (aflibercept).  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the‘601 patent.

February 8, 2023

Regeneron announced that the FDA has approved Eylea® (aflibercept) for the treatment of preterm infants with retinopathy of prematurity.  Eylea is now approved in the US to treat five retinal conditions caused by ocular angiogenesis.

January 20, 2023

PTAB instituted two IPR petitions filed by Mylan challenging Regeneron’s US10,130,681 and US10,888,601 patents, which relate to Eylea® (aflibercept).  PTAB found that Mylan demonstrated a reasonable likelihood that at least claim 1 of the ‘681 patent and claim 34 of the ‘601 patent is unpatentable as being anticipated by the same piece of prior art.  A third Mylan IPR challenge, to Regeneron’s US10,857,205 is likely to be initiated in April 2023.

January 17, 2023

Celltrion filed a petition for inter partes review of Regeneron’s US 10,464,992, relating to Eylea® (aflibercept).  Celltrion has alleged the 992 patent is invalid on obviousness and anticipation grounds.  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the 992 patent.

January 16, 2023

Business Korea has reported that Regeneron has filed patent infringement and prevention claims against Samsung Biologics and its subsidiary Samsung Boepis relating to Eylea® (aflibercept).  Regeneron claims that the Samsung Bioepis’ aflibercept (biosimilar to Eylea®) infringes Regeneron’s Korean patents.   

This comes only a few days after Samsung Bioepis filed a petition for inter partes review of Regeneron’s US10,130,681, relating to Eylea® in the US.    

January 9, 2023

Coherus Biosciences announced that it has executed a binding term sheet with Klinge Biopharma granting Coherus the exclusive US commercialisation rights to Klinge’s FYB203 (biosimilar aflibercept, targeting Bayer’s Eylea®, developed by Regeneron).  Coherus expects to complete the transaction in Q1 2023, and to file a BLA later in 2023.  Coherus plans to launch the product at biosimilar market formation, currently expected to be in 2025.

January 7, 2023

Mylan filed a petition for inter partes review of Regeneron’s US 10,130,681 and US 10,888,601, relating to Eylea® (aflibercept).  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the ‘681 and ‘601 patents.

January 6, 2023

Samsung Bioepis filed a petition for inter partes review of Regeneron’s US10,130,681, relating to Eylea® (aflibercept).  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the ‘681 patent.

2022

December 6, 2022

In its aflibercept suit against Mylan in the Northern District of West Virginia Regeneron filed an expedited motion seeking to compel Mylan  to  redesignate its biosimilar regulatory file and regulator correspondence from “Outside Counsel’s Eyes Only” (“OCEO”) to enable Regeneron’s in-house Counsel to access the materials.    Regeneron has asked the court to de-designate Mylan’s aBLA immediately to confidential, and to correct the remainder of its designations.  Regeneron asserts that its in-house Counsel has already seen a substantial portion of the materials in the patent dance.

November 9, 2022

PTAB issued decisions in Mylan’s IPR challenges relating to Regeneron’s 9,254,338 and 9,669,069 relating to Eylea® (aflibercept),  invalidating all claims the subject of the Mylan challenge, for anticipation.  Mylan’s IPRs were heard by PTAB in August 2022.  Regeneron filed a complaint against Mylan in West Virginia on 03 August 2022, alleging infringement of twenty-four patents – including the 2 subject patents – relating to Eylea® (aflibercept).

October 25, 2022

A trial date of 12 – 23 June 2023 has been set in the Regeneron v Mylan aflibercept District Court (NDWV) BPCIA dispute.  Regeneron has identified 6 patents (10,888,601, 11,053,280, 11,084,865, 11,104,715, 11,253,572 and 11,299,532) from 3 patent families for initial proceedings, and has stipulated that it will not seek injunctive relief on the other 18 patents asserted in its complaint.  This hearing date will be a mere ten months after Regeneron filed a complaint against Mylan in August 2022. Mylan filed it’s a-BLA for biosimilar aflibercept in October 2021, and received FDA notification that the application was accepted on 28 December 2021.

October 21, 2022

Regeneron announced that the FDA has granted paediatric exclusivity for Eylea® (aflibercept), extending market exclusivity in the US to 17 May 2024. Paediatric exclusivity was granted on the basis of Ph III trials of Eylea as a treatment for retinopathy of prematurity in preterm infants.

October 12, 2022

Regeneron announced that the FDA has accepted for Priority Review the sBLA for Eylea® (aflibercept) to treat retinopathy of prematurity in preterm infants.   The target action date for the FDA decision is 11 February 2023.

October 9, 2022

India’s Central Drug Standard Control Organisation granted permission to IQVIA to conduct Ph III clinical trials of Alvotech’s AVT06 (biosimilar aflibercept) for the treatment of retinal vascular diseases.

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 15, 2022

Apotex filed an IPR against Regeneron, seeking revocation of Regeneron’s method of treatment (MOT) patent US 11,253,572, relating to the sequential administration of 2mg doses of aflibercept (Eylea®) on the grounds of anticipation and obviousness.

September 8, 2022

Regeneron announced that the primary endpoints were met in two pivotal trials evaluating aflibercept 8mg with 12 and 16 week dosing regimes in diabetic macular edema and wet age-related macular degeneration.

September 7, 2022

Lupin and DKSH announced that they have signed an exclusive licensing and supply agreement to market five of Alvotech’s biosimilar products in the Philippines.  The biosimilars include AVT03 (biosimilar denosumab – Prolia® and Xgeva®), AVT05 (biosimilar golimumab/Simponi®) and AVT06 (biosimilar aflibercept/Eylea®) as well as two undisclosed proposed biosimilars for immunology and oncology.

August 10, 2022

The IPRs (inter-partes reviews) commenced by Mylan against Regeneron’s Eylea® patents 9,669,069 and 9,254,338 (instituted in December 2021) were heard by the PTAB together on 10 August 2022.  The patents relate to Regeneron’s blockbuster product Eylea® (aflibercept) and analysts have reported that (at least) the ‘338 patent is likely to be invalidated, based on comments made by the PTAB during the proceedings.

August 3, 2022

Regeneron has filed a complaint against Mylan in West Virginia under the BPCIA alleging infringement of twenty-four patents relating to Eylea® (aflibercept).  This follows the FDA’s acceptance for review of Mylan’s aBLA for its aflibercept biosimilar.  Regeneron recently listed twenty-four patents in the Purple Book as part of its patent dance with Mylan.  Mylan previously sought IPR of several aflibercept patents.

July 7, 2022

Alvotech announced the initiation of its ALVOEYE clinical trials for AVT06, biosimilar to Eylea® (aflibercept) which is indicated for the treatment of adult patients with neovascular (wet) age-related macular degeneration (AMD).  AVT06 is the third Alvotech biosimilar product to enter the clinic, and is one of eight products under development.

Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.

June 29, 2022

Regeneron announced that the FDA has accepted for review the sBLA for Eylea® (aflibercept) for a 16-week 2mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy.  The FDA has set a target action date of 28 February 2023.

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.

2021

December 7, 2021

Alvotech and Oaktree Acquisition Corp. II announced that they have entered into a merger agreement for the creation of a publicly-traded global biopharmaceutical company. Alvotech is led by a team of highly experienced biopharma leaders, including Mark Levick as CEO, Anil Okay as CCO, and Philip Caramanica as Chief IP Counsel and Deputy General Counsel. The merger is expected to deliver gross proceeds to Alvotech in excess of USD$450 million.  Alvotech currently has seven products in its pipeline, including a biosimilar candidate to Humira® (adalimumab), Stelara® (ustekinumab), Eylea® (aflibercept), Prolia®/Xgeva® (denosumab) and Simponi®/Simponi ARIA® (golimumab).

November 10, 2021

Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.

August 17, 2021

Novartis announced the results of its Ph III trials of Beovu® (brolucizumab) versus aflibercept in patients with diabetic macular edema, reporting that Beovu® demonstrated superiority versus aflibercept in key endpoints.

May 12, 2021

Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%.  Celltrion announced that it is planning to complete Ph III trials of biosimilar bevacizumab in the first half of 2021, and that ustekinumab, aflibercept, omalizumab and denosumab candidates remain in Ph III trials.

May 3, 2021

Sandoz announced it will commence enrolling patients in MYLIGHT, its Ph III efficacy and safety study of its proposed aflibercept biosimilar.  MYLIGHT will assess the efficacy and safety of the biosimilar candidate in comparison to Eylea® in patients with neovascular age-related macular degeneration.

April 8, 2021

Alteogen announced it has completed Ph I trials of its proposed aflibercept biosimilar ALT-L9. Alteogen reported that the trial confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea®.

March 5, 2021

Korea Biomedical Review reported that Alteogen has completed Ph I trials of ALT-L9 (proposed aflibercept biosimilar).

March 2, 2021

Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).

February 12, 2021

Roche announced new Ph III data shows faricimab (given at intervals of up to four months) is non-inferior compared to aflibercept (given every two months). This may reduce the treatment burden for patients suffering from diabetic macular edema and neovascular age-related macular degeneration.

February 8, 2021

Celltrion announces it has commenced Ph III trials of its proposed aflibercept biosimilar.

2020

October 30, 2020

Ocumension Therapeutics announces it has reached an agreement with Shandong Boan Biological Technology to jointly develop OT-702, a proposed aflibercept biosimilar. Under the agreement, Ocumension has been granted an exclusive license to promote and commercialise the product in mainland China. OT-702 is currently in Ph III trials.

June 30, 2020

Samsung Bioepis announces it has commenced Ph III trials of SB15, proposed aflibercept biosimilar.

June 15, 2020

Samsung Bioepis announces it has received approval to commence a global Ph III trial of SB15 (proposed aflibercept biosimilar) in patients with age-related macular degeneration.

May 22, 2020

JD Supra reports on Mylan’s Q1 earnings call. In the call, Mylan announced that the BLA and marketing authorisation for its bevacizumab candidate is currently under review by the FDA and European authorities. Mylan also confirmed that its biosimilar insulin and aflibercept projects remain on target.

May 15, 2020

Formycon releases an update on its biosimilar portfolio, announcing its biosimilar aflibercept candidate is proceeding as expected, with Ph III clinical trials expected to begin mid-2020.

2019

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.

November 3, 2019

Gene Techno Science and Kishi Kasei announce agreement for the joint development of an aflibercept biosimilar.

October 12, 2019

Alteogen announces Phase I clinical trials of biosimilar aflibercept candidate will begin this month.

August 13, 2019

Regeneron announces FDA approval for Eylea® in 2mg, single dose prefilled syringe. The product is expected to launch this year and will require fewer preparation steps in comparison to the previously approved vials.

February 22, 2019

Alteogen announces new drug application to the Ministry of Food and Drug Safety for aflibercept biosimilar, ALT-L9.

January 7, 2019

Regeneron announces $4.07 billion in 2018 US net sales for Eylea®, as it awaits the commencement of new clinical trials for a high dose formulation.  Additionally, the FDA has assigned 13 May 19 as the action date for a potential new indication in diabetic retinopathy.

January 4, 2019

Alteogen announces it has been granted a process patent for producing aflibercept biosimilar, ALT-L9.  Alteogen reports the process improves the productivity and quality of large-scale production of fusion proteins.

2018

October 25, 2018

Regeneron announces completion of Phase III clinical trials of Eylea® (aflibercept) in patients with moderately severe and severe non-proliferative diabetic retinopathy.  The company reported the trial met its one year primary endpoint and key secondary endpoints.

October 1, 2018

Momenta announces a shift in focus from biosimilars to novel therapeutics. The 5 year re-structuring plan will involve cuts to staff of 50%, however the company will continue to develop biosimilar aflibercept candidate M710.

May 10, 2018

Coherus BioSciences discloses that preclinical studies will be ongoing in 2018 for CHS-2020 biosimilar aflibercept.

January 17, 2018

Korean Biosimilar company Alteogen announces completion of pre-clinical studies relating to ALT-L9, biosimilar aflibercept, and that it intends to file an investigational NDA with the US in 2018.  It also intends to roll out aflibercept in Japan (through partner Kissei Pharmaceutical) and China in 2022 “when the patents of the brand-name drug lapse”.

January 3, 2018

Mylan and Momenta announce deal relating to the development of M710, biosimilar aflibercept.  Pivotal clinical trials are planned for early 2018.

BioBlast® extract From January 3, 2018 to February 26, 2024