Enbrel® | Etanercept | Amgen

September 15, 2020

15 Sep 20 | CA | Merck | Merck announced Health Canada has approved Brenzys® (biosimilar etanercept) for four new indications:

  • adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

  • pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy

  • reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis and improving physical function in adult patients with psoriatic arthritis (PsA)

  • reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years 

26 Aug 20 | DE | Lupin, Mylan | 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.

 

28 Jul 20 | All | Pfizer | 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. 

 

01 Jul  20 | US | Sandoz, Amgen | 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.

 

04 Jun 20 | EU | Mylan, Lupin | Mylan and Lupin announce EMA marketing authorisation for Nepexto® (etanercept) for all indications of the reference product Enbrel®.

 

22 May 20 | EU | Mylan | JD Supra reports on Mylan's Q1 earnings call. In the call, Mylan announced its partner Biocon had received FDA pre-approval of its Malaysian manufacturing facility, as well as announcing a planned launch for Nepexto® (etanercept) in Europe within months.

 

27 Mar 20 | EU | Mylan, Lupin | Mylan and Lupin announce the EU's CHMP has adopted a positive opinion recommending Nepexto® (etanercept) for all indications as Enbrel®.

 

11 Jan 20 | All | Samsung | A Polish switching study reveals Samsung's biosimilar Etanercept SB4 is effective and well tolerated by patients who switched from Enbrel®.

 

02 Jan 20 | All | Clover Pharmaeuticals | Clover announces it has commenced dosing in Ph III trials of etanercept.

 

16 Dec 19 | EU | Lupin | Lupin releases results of Ph III trials of etanercept biosimilar, reporting similarity with the reference product.

 

04 Dec 2019 | All | Amgen, Abarca | 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.

 

12 Nov 2019 | All | Sandoz | Sandoz releases results of Erelzi® studies, including interim results of the COMPACT study, and long-term cost savings modelling analysis.

 

06 Nov 2019 | CN | Biogen, Samsung Bioepis | 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.

 

24 Oct 19 | All | Celltrion | 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.

 

11 Oct 19 | US | Lupin | Lupin announces plans to file applications for biosimilar etanercept in the US market by the fourth quarter of FY20.

 

09 Oct 19 | All | Samsung Bioepis | 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.

 

10 Sep 19 | BR | Samsung Bioepis | 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.

 

12 Aug 19 | AU | Amgen, Pfizer | 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.

 

09 Aug 19 | US | Sandoz, Amgen | 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.

 

04 Jun 19 | EU | Samsung Bioepis | Samsung Bioepis announces Benepali® dominates 40% share in European etanercept biosimilar market.

 

29 May 2019 | All | Sandoz | 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.

 

29 Apr 2019 | US | Amgen, Roche, Samsung Bioepis | 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.

 

29 Apr 2019 | US | Samsung Bioepis | FDA approves biosimilar etanercept Eticovo® for all eligible indications (RA, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis).

 

26 Mar 2019 | Japan | Lupin, YL Biologics | Lupin announces approval of biosimilar etanercept in Japan for the treatment of moderate to severe Rheumatoid Arthritis. 

 

21 Jan 2019 | All | Sandoz | Health Canada approves new indication for Erelzi®, allowing for the treatment of psoriatic arthritis. 

 

01 Nov 2018 | US | Sandoz | Sandoz reports etanercept biosimilar is comparable to originator at 48 weeks. 

 

04 Aug 2018 | CN | Clover Biopharmaceuticals | Clover announces that Phase I trials of a potential Etanercept biosimilar are underway.

 

28 Jun 2018 | All | Lupin, Mylan | Lupin and Mylan announce agreement to commercialise etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and Asia.

 

15 Jun 2018 | All | Sandoz | Sandoz reports results of long term switching studies for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in RA.

 

25 May 2018 |EU |Lupin | Lupin announces that its MA application for biosimilar etanercept has been accepted for review by the EMA.

 

08 May 2018 | JP | Lupin/Yoshido/YLBiologics/Kyowa | 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.  See the YL Biologics and Yoshindo announcement here. 

 

17 Mar 2018 | KR | LG Chem | 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.  Read more

 

10 Feb 2018 | EU, JP | Lupin | Lupin declares its intention to file an application in the EU and JP for biosimilar etanercept in July 2019.

 

23 Jan 2018 | CN | Clover Biopharmaceuticals/GE | 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.  Read more

 

19 Jan 2018 | JP | Mochida/Ayumi/LG Chem |Mochida receives approval for the first biosimilar etanercept in Japan, developed in Japan in collaboration with LG Chem, to be distributed in Japan by Ayumi.  The application took approximately 11 months to be approved by the PMDA.  

 

22 Dec 2017 |CN | Clover |Clover announced it has received approved to enter clinical trials in China with SCB-808, biosimilar etanercept.

 

01 Dec 2017 | AU | Samsung Bioepis | 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.

 

30 Nov 2017 | AU | Sandoz | Sandoz's biosimilar etanercept (Erelzi®)  approved in Australia in 3 dosages, the second approved biosimilar etanercept.

 

17 Nov 2017 | US | Amgen | Amgen announces US launch of new ENBREL Mini® single-dose prefilled cartridge with AutoTouch® reusable autoinjector. 

 

12 Sep 2017 | All | Lupin | Lupin secures external funding for its etanercept biosimilars program.  Read more


21 Aug 2017 | CA | Sandoz | Sandoz launches Erelzi® in Canada.  Read more

 

27 Jun 2017 | EU | Sandoz | Biosimilar etanercept (Erelzi®) approved in EU to treat multiple inflammatory diseases.  Read more

 

Apr 2017 | CA | Sandoz | 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).  Read more

 

01 Apr 2017 | AU | Samsung Bioepis | Samsung's biosimilar etanercept, Brenzys, is listed on the PBS in Australia with "A" flagging enabling substitution at the pharmacy level

 

16 Dec 2016 | EU | Samsung Bioepis | Samsung Bioepis receives positive CHMP opinion for its  application for indication extension of Benepali® (etanercept) to include juvenile idiopathic arthritis and pediatric plaque psoriasis.  Read more


12 Sept 2016 | CA | Samsung Bioepis | Brenzys®(SB4)  is the first biosimilar etanercept to be approved in Canada.  Read more

 

22 Jul 2016 | AU | Samsung Bioepis |  Brenzys® (SB4) becomes the first biosimilar etanercept to be approved in Australia.  Read more

 

30 Aug 2016| US | Sandoz | 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.  Read more

 

17 Jan 2016 | EU | Samsung Bioepis | 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.  Read more

 

7 Sep 2015 | KR | Samsung Bioepis/Merck | Brenzes® (SB4), biosimilar etanercept,  approved in South Korea with launch intended late 2015/early 2016.  Read more

 

 

 

 

 

 

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August 19, 2020

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