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2022Pfizer commences patent infringement proceedings against Samsung Bioepis, Merck, Organon and Arrow PharmaceuticalsMay 6, 2022
Pfizer commenced patent infringement proceedings in the Federal Court of Australia against Samsung Bioepis, Merck, Organon and Arrow Pharmaceuticals in relation to AU2005280034 and the supply of etanercept. |
Amgen publishes its Q1 2022 financial resultsApril 27, 2022
Amgen released its Q1 2022 financial results, reporting a 6% increase in YoY revenues. Amgen reported a 12% increase in Prolia® (denosumab) sales, a 7% decrease in Enbrel® (etanercept) sales, a 2% increase in Amgevita™ (biosimilar adalimumab) sales and a 40% decrease in Kanjinti® (biosimilar trastuzumab) sales. |
Samsung Bioepis secured 10 biosimilar products on its 10th year anniversaryFebruary 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. |
2021AU | AU’s PBAC publishes the outcomes from its July 2021 meetingNovember 12, 2021
AU’s PBAC published the outcomes from its July 2021 meeting. PBAC recommended listing:
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UK | UK’s NICE recommends biologics for treatment of moderate RAJuly 14, 2021
The UK’s NICE finalised its guidance on the treatment of moderate rheumatoid arthritis, recommending the use of adalimumab, etanercept, infliximab and abatacept for patients with moderate rheumatoid arthritis which is inadequately controlled on conventional therapies. |
UK | UK’s NICE recommends biologics for moderate RAJune 10, 2021
The UK’s NICE published final draft guidance recommending adalimumab, etanercept and infliximab for the treatment of moderate rheumatoid arthritis on the NHS. Previously, biologics had been recommended only for severe rheumatoid arthritis. |
US | Sandoz appeal to US Supreme Court dismissedMay 18, 2021
The US Supreme Court declined to hear Novartis’ appeals against a lower court decision which upheld two Amgen patents relating to Enbrel® (etanercept). Keren Haruvi, President of Sandoz US and Head of North America estimates that a biosimilar etanercept in the US could have saved payees USD$1 billion annually. |
Samsung Bioepis releases its Q1 2021 financial resultsApril 23, 2021
Samsung Bioepis released its Q1 2021 financial results. Global sales for Benepali® (biosimilar etanercept), Flixabi® (biosimilar infliximab) and Imraldi® (biosimilar adalimumab) increased 3.9% quarter-on-quarter, with Benepali® accounting for the largest share of those sales. |
CA | BC expands its biosimilars switching programApril 7, 2021
British Columbia expanded its biosimilars switching program to include adalimumab, and expanded coverage of etanercept. BC announced that almost 6,000 patients currently treated with Humira® will be switched to either Amgevita® (Amgen), Hadlima® (Merck/Samsung), Hulio® (Mylan), Hyrimoz® (Sandoz) or Idacio® (Fresenius Kabi) over a 6 month period. New and existing plaque psoriasis patients currently being treated by Enbrel® will also be transitioned to Brenzys® (Samsung Bioepis/Merck) or Erelzi® (Sandoz) over the same period. |
2020AU | Lupin biosimilar etanercept Etera® and Rymti® approvedOctober 1, 2020
Lupin receives approval for biosimilar etanercept in Australia under the trade names Etera® and Rymti® in PFS presentations. |
CA | Merck announces Health Canada approval of Brenzys® for indicationsSeptember 15, 2020
Merck announced Health Canada has approved Brenzys® (biosimilar etanercept) for four new indications:
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DE | Lupin and Mylan launch Nepexto® in GermanyAugust 26, 2020
Lupin and Mylan launch Nepexto® (biosimilar etanercept) in Germany. Nepexto® is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, severe axial spondyloarthritis and plaque psoriasis. |
Pfizer Q2 FY20 financial results releasedJuly 28, 2020
Pfizer releases its Q2 FY20 financial results. Pfizer reported a 16% decrease in international revenues for Enbrel® (etanercept), attributing this decrease to biosimilar competition in Europe, Japan and Brazil. |
US | Sandoz responds to US Court of Appeals judgement upholding judgement of Amgen etanercept patents validJuly 1, 2020
Sandoz responds to the US Court of Appeals judgment which upheld a ruling from the New Jersey District Court which declared the Amgen patents relating to (etanercept) valid. Sandoz stated that it will continue its efforts to make Erelzi® available in the US, and is evaluating its options, including a possible appeal to the US Supreme Court. |
EU | Mylan and Lupin Nepexto® receives EMA marketing authorisationJune 4, 2020
Mylan and Lupin announce EMA marketing authorisation for Nepexto® (etanercept) for all indications of the reference product Enbrel®. |
EU | Mylan Q1 earnings call released by JD SupraMay 22, 2020
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EU | EU’s CHMP recommends Mylan and Lupin Nepexto® for indicationsMarch 27, 2020
Mylan and Lupin announce the EU’s CHMP has adopted a positive opinion recommending Nepexto® (etanercept) for all indications as Enbrel®. |
HK | TW | Mundipharma enters exclusive commercialisation agreement with SamsungJanuary 13, 2020
Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung’s adalimumab, etanercept, trastuzumab and bevacizumab candidates in Taiwan and Hong Kong. |
Clover dosing in Ph III trials of etanercept commencesJanuary 11, 2020
Clover announces it has commenced dosing in Ph III trials of etanercept. |
Clover receives approval for clinical trials in ChinaJanuary 2, 2020
Clover announces it has received approved to enter clinical trials in China with SCB-808, biosimilar etanercept. |
2019EU | Lupin Ph III trials of etanercept biosimilar results releasedDecember 16, 2019
Lupin releases results of Ph III trials of etanercept biosimilar, reporting similarity with the reference product. |
Outcome based agreement for Enbrel® announced by Amgen and AbarcaDecember 4, 2019
Amgen and pharmacy benefit manager Abarca announce outcome based agreement for Enbrel®, under which Amgen will provide rebates to Abarca’s clients who start etanercept to treat RA but discontinue treatment after 3 months. This is the second outcome-based between Abarca and Amgen, the prebvious (2018) arrangement related to hyperlipidemia medicine Repatha. |
Sandoz releases results of Erelzi® studiesNovember 12, 2019
Sandoz releases results of Erelzi® studies, including interim results of the COMPACT study, and long-term cost savings modelling analysis. |
CN | Biogen and Samsung Bioepis partnership for commercialisation announcedNovember 6, 2019
Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilar ranibizumab and aflibercept for major markets world side including the US, Canada, Europe, Japan and Australia. Biogen has also acquired exclusive commercialisation rights for its anti-TNF portfolio, including BENEPALI® (etanercept), FLIXABI® (infliximab) and IMRALDI® (adalimumab), in China. Under the agreement, Biogen will make one $100 million upfront payment, with up to $210 million payable at additional development, regulatory and sales-based milestones. |
Celltrion 3 post marketing studies of etanercept biosimilar results releasedOctober 24, 2019
Celltrion presents pooled data from 3 post marketing studies of etanercept biosimilar, reporting that the study shows real-world evidence of the safety of the product. |
US | Lupin plans to file US market applications for biosimilar etanerceptOctober 11, 2019
Lupin announces plans to file applications for biosimilar etanercept in the US market by the fourth quarter of FY20. |
Results of Samsung Bioepis Benepali® psoriasis study releasedOctober 9, 2019
Samsung Bioepis releases results of Benepali® psoriasis study, announcing results demonstrate the product’s effectiveness and safety in a real-world setting. The study was conducted by the British Association of Dermatologists, Biologics and Immunomodulators Registry and enrolled 269 patients with moderate to severe psoriasis. |
BR | Samsung Bioepis receives Brazilian approval for Brenzys®September 10, 2019
Samsung Bioepis announces Brazilian approval for Brenzys®. For the first 10 years, Samsung Bioepis willl supply the drug to local distributors, during which a technology transfer with local partners will take place, allowing local partners to take over manufacturing after this period. |
AU | Quarterly etanercept data reveals slow uptakes of biosimilar in AU marketAugust 12, 2019
Quarterly etanercept data reveals biosimilar uptake remains slow in the Australian market. While the uptake of Brenzys® (MSD) has steadily grown, the biosimilar still only forms 15% of total scripts. |
US | US District Court rules against Sandoz in patent litigationAugust 9, 2019
Sandoz announces US District Court ruled against Sandoz in patent litigation, preventing the launch of Erelzi®. Sandoz has announced that they will appeal this decision, and that both parties have agreed to an expedited appeal. |
EU | Samsung Bioepis announces Benepali® share in EU etanercept biosimilar marketJune 4, 2019
Samsung Bioepis announces Benepali® dominates 40% share in European etanercept biosimilar market. |
Results of 24 week switching study on Sandoz candidate releasedMay 29, 2019
Results of 24 week switching study released, citing no changes in safety or efficacy outcomes. The study was conducted in patients with moderate to severe rheumatoid arthritis and compared the outcomes of those who swapped to the Sandoz candidate at 24 weeks and those who continued with the reference drug. |
US | Amgen and Roche file suit alleging infringement of patents in response to FDA approval of Eticovo®April 29, 2019
In response to FDA approval of Eticovo®, Amgen and Roche file a suit alleging the infringement of five patents. Within the complaint, Amgen and Roche allege that Samsung failed to provide them with a copy of its aBLA or details of the manufacturing process, as well as failing to provide the 180 day notice of commercial marketing. |
US | FDA approves biosimilar etanercept Eticovo®April 29, 2019
FDA approves biosimilar etanercept Eticovo® for all eligible indications (RA, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis). |
JP | Lupin biosimilar etanercept approved in JapanMarch 26, 2019
Lupin announces approval of biosimilar etanercept in Japan for the treatment of moderate to severe Rheumatoid Arthritis. |
Health Canada approves new indication for Erelzi®January 21, 2019
Health Canada approves new indication for Erelzi®, allowing for the treatment of psoriatic arthritis. |
2018US | Sandoz etanercept biosimilar comparable to originatorNovember 1, 2018
Sandoz reports etanercept biosimilar is comparable to originator at 48 weeks. |
CN | Ph I trials of Clover etanercept biosimilar commenceAugust 4, 2018
Clover announces that Phase I trials of a potential etanercept biosimilar are underway. |
Lupin and Mylan agreement to commercialise etanercept biosimilarJune 28, 2018
Lupin and Mylan announce agreement to commercialise etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and Asia. |
Sandoz biosimilars Zessly® and Erelzi® results reportedJune 15, 2018
Sandoz reports results of long term switching studies for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in RA. |
EU | Lupin MA application for biosimilar etanercept accepted for EMA reviewMay 25, 2018
Lupin announces that its MA application for biosimilar etanercept has been accepted for review by the EMA. |
JP | Lupin files BLA for biosimilar etanercept (YBL113) in JapanMay 8, 2018
Lupin announced YL Biologics has filed a BLA for biosimilar etanercept (YBL113) in Japan. YL Biologics is a joint venture between Yoshindo and Kyowa (Lupin’s subsidiary), and YBL113 is the first biosimilar developed by the JV. |
KR | LG Chem obtains Korean regulatory approval for biosimilar etanerceptMarch 17, 2018
LG Chem (formerly LG Life Sciences) obtains Korean regulatory approval for biosimilar etanercept. This is the second biosimilar etanercept approved in Korea (after Samsung’s 2015 approval of Brenzys), and follows the Japanese approval of LG Chem’s biosimilar etanercept in January this year. |
EU | JP | Lupin intends to file application in EU and JP for biosimilar etanerceptFebruary 10, 2018
Lupin declares its intention to file an application in the EU and JP for biosimilar etanercept in July 2019. |
CN | GE builds FlexFactory facility in ChinaJanuary 23, 2018
GE announces it is building a FlexFactory (single use technology with 2 x 2000L bioreactors) facility in China for Clover, which is expected to be up and running by the end of 2018. Clover intends to manufacture biosimilar etanercept for the Chinese market there. |
JP | Mochida biosimilar etanercept approved in JapanJanuary 19, 2018
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2017AU | AU Gov’t biosimilar initiative results in changes to PBS listing of Brenzys®December 1, 2017
The Australian government’s biosimilar uptake initiative results in changes to PBS listing for Samsung’s Brenzys® in Australia. “A” flagging (substitution at the pharmacy level) remains unchanged. |
AU | Erelzi® approved in AustraliaNovember 30, 2017
Sandoz’s biosimilar etanercept (Erelzi®) approved in Australia in 3 dosages, the second approved biosimilar etanercept. |
US | Amgen launches Enbrel Mini® in the USNovember 17, 2017
Amgen announces US launch of new ENBREL Mini® single-dose prefilled cartridge with AutoTouch® reusable autoinjector. |
Lupin secures external funding for etanercept programSeptember 13, 2017
Lupin secures external funding for its etanercept biosimilars program. |
CA | Sandoz launches Erelzi® in CanadaAugust 21, 2017
Sandoz launches Erelzi® in Canada. |
EU | EMA approves Erelzi®June 27, 2017
Biosimilar etanercept (Erelzi®) approved in EU to treat multiple inflammatory diseases. |
CA | Health Canada grants NOC for ErelziApril 4, 2017
Sandoz receives a Notice of Compliance for Erelzi® for the treatment of moderately to severely active rheumatoid arthritis in adults with or without methotrexate and for reducing signs and symptoms of active ankylosing spondylitis. (Sandoz did not seek registration for psoriatic arthritis or plaque psoriasis). |
AU | Brenzys receives ‘A flagged’ designation on the PBSApril 1, 2017
Samsung’s biosimilar etanercept, Brenzys, is listed on the PBS in Australia with “A” flagging enabling substitution at the pharmacy level |
2016EU | EMA approves Benepali® indication extensionDecember 16, 2016
Samsung Bioepis receives positive CHMP opinion for its application for indication extension of Benepali® (etanercept) to include juvenile idiopathic arthritis and pediatric plaque psoriasis. |
CA | Health Canada approves Brenzys®September 12, 2016
Brenzys®(SB4) is the first biosimilar etanercept to be approved in Canada. |
AU | TGA approves Brenzys®July 22, 2016
Brenzys® (SB4) becomes the first biosimilar etanercept to be approved in Australia. |
US | FDA approves Erelzi®July 13, 2016
FDA approves Sandoz’s Erelzi® for all indications included in the reference product label, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. |
EU | EMA approves Benepali®January 17, 2016
EMA approves Benepali®, biosimilar etanercept (SB4) for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. CHMP positive opinion was announced on 20 Nov 2015. Samsung says it developed, tested and had its Benepali® approved in under 4 years. |
2015KR | Brenzys® approved in South KoreaSeptember 7, 2015
Samsung Bioepis announces Brenzys® (SB4), biosimilar etanercept received approval in South Korea with launch intended late 2015/early 2016. |
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
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
infliximab | Remicade® | Johnson & Johnson
natalizumab | Tysabri® | Biogen/Elan
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
rituximab | Rituxan®/MabThera® | Genentech/Biogen
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
BioBlast® Editor and Contributing Author

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