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2024
On 26 February 2024, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the use of Voydeya® (danicopan) as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.
CHMP based its positive opinion on results from the ALPHA Phase III trial which were published in The Lancet Haematology journal on 27 November 2023.
PulseNews reported that Samsung Bioepis has received approval for Episcli® (SB12), biosimilar to Alexion’s Soliris® (eculizumab), from the Korean Ministry of Food and Drug Safety. Episcli® is approved to treat nocturnal hemoglobinuria.
On 3 January 2024 Alexion sued Samsung Bioepis in the US District Court for the District of Delaware asserting infringement of six of its eculizumab patents.
Alexion filed a complaint against Samsung in the US District Court for the District of Delaware asserting infringement of six US eculizumab patents. The allegations relate to Samsung’s abbreviated Biologics License Application (aBLA) for SB12, its biosimilar to Alexion’s Soliris® (eculizumab), accepted by the US Food and Drug Administration (FDA) on 7 July 2023. Soliris® is a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and other conditions. On 7 July 2023, Samsung provided its 180-day notice of commercial marketing to Alexion.
In August 2023, Amgen appealed Alexion’s successful preliminary injunction order regarding Amgen’s off-label use of its eculizumab biosimilar Bekemv® in Germany.
2023
The US Patent Trial and Appeal Board (PTAB) has instituted two more of Samsung Bioepis’ inter partes review (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent. The IPRs relate to US patent nos. 10,590,189 and 10,703,809 in IPR proceedings IPR2023-01069 and IPR2023-01070 respectively. The patents cover method of treatment claims in treating paroxysmal nocturnal hemoglobinuria (PNH).
On 8 December 2023, PTAB instituted three other Samsung Bioepis petitions against Alexion’s Soliris® patent: US patent nos. 9,725,504, 9,718,880 and 9,732,149. Samsung Bioepis launched Epysqli®, biosimilar to Soliris®, in three European countries on 19 October 2023. Epysqli® was approved by the EMA on 30 May 2023.
The US Patent Trial and Appeal Board (PTAB) has instituted three of Samsung Bioepis’ inter partes reviews (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent nos. 9,725,504, 9,718,880 and 9,732,149 in IPR proceedings IPR2023-00999, IPR2023-00998 and IPR2023-00933 respectively. The patents cover method of treatment, pharmaceutical composition and API claims.
Samsung Bioepis recently launched Epysqli®, biosimilar to Soliris®, in three European countries on 19 October 2023. Epysqli® was approved by the EMA on 30 May 2023.
The Korea Herald reported that Samsung Bioepis has launched Epysqli®, its biosimilar to AstraZeneca/Alexion’s Soliris® (eculizumab) in three European countries. Samsung Bioepis confirmed it is preparing to launch Epysqli® in France and the Netherlands by the end of 2023.
Samsung Bioepis’ Epysqli® was approved by the EMA on 30 May 2023.
AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved Soliris® (eculizumab) to treat a new indication: neuromyelitis optica spectrum disorder (NMOSD). Soliris® is the first and only complement inhibitor approved for the treatment of NMOSD in China.
On 24 August 2023 Soliris® was approved in Japan for a new indication to treat paediatric patients with generalised myasthenia gravis.
AstraZeneca announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for the extended use of Soliris® (eculizumab) to treat paediatric patients suffering from generalised myasthenia gravis (gMG). This approval specifically targets those who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control through high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). Soliris® is the exclusive targeted therapy cleared for treating gMG in Japanese children and adolescents.
On the same day AstraZeneca also announced the MHLW expanded approval for it and Merck’s Lynparza® (olaparib) with abiraterone to treat BRCAm mCRPC.
Managing IP has reported that Amgen filed an appeal with Germany’s Federal Court of Justice against a preliminary injunction order made by the Munich District Court on 4 August 2023. The preliminary injunction prevents Amgen from supplying Bekemv®, its biosimilar to Alexion’s Soliris® (eculizumab), in Germany unless certain conditions are met, including a requirement that Amgen customers, including hospitals, agree not to use Bekemv® off-label.
On 19 April 2023, the EMA approved Bekemv® for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) (after the CHMP provided its positive opinion on 23 February 2023). Alexion successfully applied to the Munich Regional Court for a preliminary injunction in May 2023, which was upheld by the 4 August 2023 District Court ruling.
The ODE rights expired in June 2019 for PNH. However Alexion argued that there was a real risk that the biosimilar would be used off-label to treat other conditions over which Alexion still has exclusive rights. The District Court noted that by sending letters of recommendation to medical practitioners, Amgen contributed to the risk of Bekemv®’s off-label use.
Alexion has also sued Samsung Bioepis in Germany over its eculizumab biosimilar Epysqli®, approved by the EMA on 30 May 2023, with a preliminary injunction hearing scheduled for 16 August 2023.
AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the MA for Astra Zeneca’s Soliris® (eculizumab) be expanded to include the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor antibody-positive. AZ confirmed that regulatory submissions for Soliris® for the treatment of paediatric patients with gMG are pending or planned with multiple health authorities.
On 13 June 2023 the Chinese NMPA approved Soliris® for treatment of gMG in adults who are anti-acetylcholine receptor antibody-positive.
Samsung Bioepis has filed an IPR in the US against Alexion’s Soliris® (eculizumab) patent 10,703,809 (’809 patent) advocating that all claims of the ‘809 patent are obvious in light of the prior art (including patent applications, a granted patent, manuscripts and a journal article).
On the same day, Samsung Bioepis also filed an IPR against Janssen’s Stelara® (ustekinumab) patent no. 10,961,307 (‘307 patent), addressed here
AstraZeneca announced that the Chinese NMPA has approved Soliris® (eculizumab) for treatment of refractory generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. This is the third approved indication approved for Soliris® in China, and is the first and only complement inhibitor approved to treat gMG in China. The NMPA’s approval was based on results of the Phase III REGAIN trial in which Soliris® demonstrated clinical benefit for patients with anti-AChR antibody-positive gMG who had previously failed immunosuppressive treatment and suffered significant unresolved disease symptoms.
Biosimilars to Soliris® are in the pipeline: on 30 May 2023 Samsung Bioepis’ Epysqli® (eculizumab) was approved in Europe to treat paroxysmal nocturnal hemoglobinuria, and on 23 February 2023 the CHMP recommended MA for Amgen’s Bekemv® for the same condition.
The European Commission (EC) has granted Marketing Authorisation for Samsung Bioepis’ Epysqli® (eculizumab), biosimilar to Alexion’s Soliris®. Epysqli® is approved for the treatment of adult and children patients with paroxysmal nocturnal hemoglobinuria (PNH), and is Samsung Bioepis’ first hematology biosimilar.
The EMA Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for Epysqli® on 30 March 2023.
EMA recommended granting marketing authorisation for Samsung Bioepis’ Epysqli™ (eculizumab), biosimilar to Alexion’s Soliris®. Epysqli is indicated for the treatment of adults and children with paroxysmal nocturnal haemoglobinuria. According to Samsung Bioepis, Epysqli™ is Samsung Bioepis’ first haematology biosimilar to be recommended for approval in Europe.
On 23 February, EU’s CHMP recommended a grant of market authorisation for Bekemv®, Amgen’s eculizumab biosimilar.
The EMA CHMP has recommended a grant of market authorization for Bekemv®, Amgen’s eculizumab biosimilar to Alexion’s Soliris® (eculizumab). Bekemv is indicated for the treatment of paroxysmal nocturnal haemoglobinuria in adults and children.
2022
Amgen announced the results of a Ph III study evaluating the efficacy and safety of ABP959 (proposed eculizumab biosimilar) compared with Soliris® in adult patients with paroxysmal nocturnal haemoglobinuria. Amgen reported that the study met its primary endpoints and that the safety and immunogenicity profile of ABP 959 was comparable to Soliris.
Samsung Bioepis presented data from its Ph III trials of SB12 (eculizumab biosimilar) in paroxysmal nocturnal hemoglobinuria at the European Hematology Association 2022, reporting that SB12 is bioequivalent to Alexion’s Soliris®.
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.
2021
Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I study.
Korea Biomedical Review announced that Samsung Bioepis has completed Ph III trials of SB12 (proposed eculizumab biosimilar) for the treatment of paroxysmal nocturnal hemoglobinuria.
2020
Biopharma supplier Alexion announces it will be acquired by AstraZeneca. The acquisition is expected to close in Q3 2021 for total consideration to Alexion shareholders of $39bn. Under the deal, AstraZeneca will acquire Alexion’s pipeline of 11 molecules, as well as Alexion’s blockbuster products Soliris® (eculizumab) and Ultomiris® (ravulizumab).
In a filing to the Securities and Exchange Commission, Alexion announces it has settled its eculizumab dispute with Amgen. Under the agreement, Amgen will receive a non-exclusive, royalty-free license to market its product from 01 March 2025.
Samsung and AffaMed announce Chinese approval for Phase III trials of eculizumab candidate.
2019
Alexion reveals that the EPO denied two patent applications relating to its eculizumab product, as they await the full written response.
US Patent and Trial Board commences an inter partes review of Alexion’s eculizumab patents following Amgen’s claims that they were anticipated or obvious.
Samsung Bioepis commences patient enrolment for Phase III clinical study of eculizumab biosimilar candidate, SB12.
Selexis announces first biosimilar eculizumab approval in Russia through partnership with Generium.
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.
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
natalizumab | Tysabri® | Biogen/Elan
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
BioBlast® Editor and Contributing Author
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