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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: etanercept

2024

January 31, 2024

A study by the Italian University of Bologna published in Springer Link’s Clinical Drug Investigation, found that Sandoz’s GP2015 (etanercept biosimilar), Samsung Bioepis SB4 (etanercept biosimilar) and Sandoz’s GP2017 (adalimumab biosimilar) have equivalent effectiveness over a long period of time, compared to originator medicines etanercept and adalimumab respectivelyThe study recruited a total of 1598 patients with rheumatoid arthritis and monitored them for over 48 months during treatment

2023

December 20, 2023

mAbxience announced it has entered a licence agreement with Intas Pharmaceuticals, under which Intas will gain the right to commercialise etanercept (biosimilar to Amgen’s Enbrel®) in more than 150 countries including Europe and the US for various autoimmune disorders.  mAbxience (majority owned by Fresenius Kabi, partially owned by Insud Pharma) will develop, manufacture and supply the etanercept biosimilar.

On 20 September 2023, mAbxience reached an agreement with Abbott to commercialise several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets in Latin America, Southeast Asia, the Middle East and Africa.

December 19, 2023

A study published in Reumatismo found that Samsung Bioepis’ SB4, biosimilar to Amgen’s Enbrel® (etanercept), and Amgen’s ABP501, biosimilar to AbbVie’s Humira® (adalimumab) both have similar safety profiles to their respective originator products in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.  The study also found that there was a reduced biosimilar retention rate at 24 months.  It concluded that biosimilars “could be considered a valid, safe, and less expensive alternative to originators”.

October 30, 2023

A Sandoz study published in Drug Safety found that eight Sandoz biosimilars (adalimumab (Hyrimoz®), epoetin alfa (Binocrit®), etanercept (Erelzi®), filgrastim (Zarzio®), infliximab (Zessly®), pegfilgrastim (Ziextenzo®), rituximab (Rixathon®), and somatropin (Omnitrope®) “can be used as safely as their respective reference biologics” based on real-world experience of all eight marketed products.   The study summarised post-approval cumulative patient exposure and safety experience for the eight products based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding PSUR assessment reports authored by health authorities, where available, as of 31 January 2023.  The authors also concluded that “it is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)”.

October 18, 2023

The FDA approved Amgen’s Enbrel® (etanercept) on 18 October 2023 for a new indication: active juvenile psoriatic arthritis (JPsA) in paediatric patients 2 years of age and older.

On 21 March 2023, one of the largest studies to date examining etanercept biosimilar/originator outcomes found that Biogen’s Benepali® and Novartis’ Erelzi® demonstrated comparable efficacy to Enbrel®.   Erelzi® was the first etanercept biosimilar approved by the FDA on 30 August 2016, with  Samsung Bioepis’ Eticovo® (marketed as Benepali® in Europe) receiving FDA approval on 25 April 2019.

October 3, 2023

An FDA meta-analysis found that there are no differences in safety profiles or immunogenicity rates in patients who switched to biosimilars compared to those who remained on an originator biologic or biosimilar.  Biologics assessed in the study include adalimumab, epoetin alfa-epbx, etanercept, filgrastim, infliximab, insulin glargine, rituximab, and trastuzumab.  

On 18 September 2023, the FDA released its draft industry guidance for biosimilar and interchangeable biosimilar product labelling.   

September 14, 2023

According to the Pharmaceutical Benefits Assessment Committee (PBAC) November 2023 agenda published last week, the meeting will be jammed with biopharma applications for reimbursement.  PBAC will consider the following applications for PBS listing additions or amendments at its November 2023 meeting:

New listing applications: Amendment Applications
1. Organon’s Hadlima® (adalimumab) biosimilar to AbbVie’s Humira® 1. Sanofi-Aventis’ Libtayo® (cemiplimab)
2. GSK’s Jemperli® (dostarlimab) 2. BMS’s Opdivo® (nivolumab)
3. Vertex’s Kalydeco® (ivacaftor) 3. Merck’s Keytruda® (pembrolizumab)
4. GSK’s Menveo® (meningococcal vaccine) 4. AbbVie’s Skyrizi® (risankizumab)
5. Pfizer’s Prevenar 20® (pneumococcal conjugate vaccine) 5. Novartis’ Cosentyx® (secukinumab)
6. Generic Health’s Teriparatide Lupin® (teriparatide) biosimilar to Eli Lily’s Forteo®
7. Gedeon Richter’s Terrosa® (teriparatide) biosimilar to Eli Lily’s Forteo®
8. Beigene’s Tevimbra® (tiselizumab)
9. AstraZeneca’s Enhertu® (trastuzumab deruxtecan) biosimilar to Genentech’s Herceptin®

 
In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to Alphapharm’s Hulio® (adalimumab, biosimilar to AbbVie’s Humira®), Pfizer’s Zirabev® (bevacizumab, biosimilar to Genentech’s Avastin®) and Alphapharm’s Rymti® (etanercept) biosimilar to Amgen’s Enbrel®.

On 1 March 2023, the November 2022 PBAC outcomes were announced, with three biologics listed, including Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms, Merck’s pembrolizumab (Keytruda®) and AbbVie’s risankizumab (Skyrizi®).

May 26, 2023

A study published in JAMA Network Open has found in a systematic review and meta-analysis that biosimilars of adalimumab, etanercept, and infliximab were associated with clinically equivalent effects in patients with rheumatoid arthritis compared with their reference biologics (AbbVie’s Humira®, Amgen’s Enbrel® and J&J’s Remicade® respectively).  The authors assessed 25 head-to-head trials (including 10,642 randomised participants) and found the biosimilars were associated with similar rates of adverse events, study discontinuation, and immunogenicity responses compared with reference biologics.

Only two weeks ago on 8 June 2023, the Ph III results of Samsung Bioepis’ SB15 (aflibercept biosimilar) published in JAMA Ophthalmology showed equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to reference aflibercept.

March 21, 2023

A new study published in Rheumatology has found that etanercept biosimilars (Biogen’s Benepali® and Novartis’ Erelzi®) demonstrated comparable efficacy to Pfizer’s Enbrel®.  The study is one of the largest to date, and showed that biologic-naïve rheumatoid arthritis patients had similar outcomes in terms of survival and disease activity whether they received the originator or biosimilar treatment.

The study was supported by the British Society for Rheumatology.

2022

December 20, 2022

Ontario announced that it will adopt a biosimilars switching program from 31 March 2023.  Patients currently treated with Copaxone® (glatiramer acetate), Enbrel® (etanercept), Humalog® (insulin lispro), Humira® (adalimumab), Lantus® (insulin glargine), NovoRapid® (insulin aspart), Remicade® (infliximab), and Rituxan® (rituximab) will be required to transition to the biosimilar version by 29 December 2023.  Ontario is the 8th jurisdiction to adopt a biosimilars switching program, following British Columbia, Alberta, New Brunswick, Quebec, Northwest Territories, Nova Scotia and Saskatchewan.

November 7, 2022

Amgen announced that it will present data across its portfolio at the American College of Rheumatology Convergence on 10-14 November 2022, including data for Amgevita® (biosimilar adalimumab), Enbrel® (biosimilar etanercept) and Prolia® (biosimilar denosumab).

September 13, 2022

Lupin announced that Health Canada has approved Rymti® (biosimilar etanercept) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondylarthritis (including ankylosing spondylitis and non-radiographic axial spondylarthritis), plaque psoriasis and paediatric plaque psoriasis.

July 27, 2022

Alphapharm (Viatris’ Australian subsidiary) has its etanercept biosimilar, Nepexto®, on the agenda for the November PBAC meeting.  If the PBAC recommends that Nepexto is PBS-listed, it will become the third PBS-listed etanercept product after Pfizer’s Enbrel® and Arrow’s Brenzys®.

May 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.

April 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.

February 28, 2022

The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10th year anniversary.  Six biosimilars have been approved globally: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab and ranibizumab.  Eculizumab has recently completed its Ph III clinical trial, and three other biosimilar candidates are under Ph III trials.

2021

November 12, 2021

AU’s PBAC published the outcomes from its July 2021 meeting. PBAC recommended listing:

  • Pfizer’s Abrilada® (50mg/mL adalimumab biosimilar) in 20mg/0.4mL syringe, 40mg/0.8mL syringe and 40mg/0.8mL pen for all indications as Humira®.
  • Janssen’s Darzalex SC® (daratumumab) for all indications for which the intravenous form of daratumumab is currently listed.
  • Pfizer’s Enbrel® (etanercept) in 50mg/1mL single use dose-dispenser cartridges under the same conditions as existing listings for etanercept.
  • BMS’ Opdivo® (nivolumab) for the treatment of patients with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression following treatment with a fluoropyrimidine and platinum (FP)-based chemotherapy regimen.

July 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.

June 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.

May 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.

April 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.

April 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.

2020

October 1, 2020

Lupin receives approval for biosimilar etanercept in Australia under the trade names Etera® and Rymti® in PFS presentations.

September 15, 2020

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

August 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.

July 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. 

July 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.

June 4, 2020

Mylan and Lupin announce EMA marketing authorisation for Nepexto® (etanercept) for all indications of the reference product Enbrel®.

May 22, 2020

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.

March 27, 2020

Mylan and Lupin announce the EU’s CHMP has adopted a positive opinion recommending Nepexto® (etanercept) for all indications as Enbrel®.

January 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.

January 11, 2020

Clover announces it has commenced dosing in Ph III trials of etanercept.

January 2, 2020

Clover announces it has received approved to enter clinical trials in China with SCB-808, biosimilar etanercept.

2019

December 16, 2019

Lupin releases results of Ph III trials of etanercept biosimilar, reporting similarity with the reference product.

December 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.

November 12, 2019

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

November 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.

October 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.

October 11, 2019

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

October 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.

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.

August 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.

August 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.

June 4, 2019

Samsung Bioepis announces Benepali® dominates 40% share in European etanercept biosimilar market.

May 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.

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.

April 29, 2019

FDA approves biosimilar etanercept Eticovo® for all eligible indications (RA, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis).

March 26, 2019

Lupin announces approval of biosimilar etanercept in Japan for the treatment of moderate to severe Rheumatoid Arthritis. 

January 21, 2019

Health Canada approves new indication for Erelzi®, allowing for the treatment of psoriatic arthritis. 

2018

November 1, 2018

Sandoz reports etanercept biosimilar is comparable to originator at 48 weeks.

August 4, 2018

Clover announces that Phase I trials of a potential etanercept biosimilar are underway.

June 28, 2018

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

June 15, 2018

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

May 25, 2018

Lupin announces that its MA application for biosimilar etanercept has been accepted for review by the EMA.

May 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.

March 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.

February 10, 2018

Lupin declares its intention to file an application in the EU and JP for biosimilar etanercept in July 2019.

January 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.

January 19, 2018

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.

2017

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.

November 30, 2017

Sandoz’s biosimilar etanercept (Erelzi®)  approved in Australia in 3 dosages, the second approved biosimilar etanercept.

November 17, 2017

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

September 13, 2017

Lupin secures external funding for its etanercept biosimilars program.

August 21, 2017

Sandoz launches Erelzi® in Canada.

June 27, 2017

Biosimilar etanercept (Erelzi®) approved in EU to treat multiple inflammatory diseases.

April 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).

April 1, 2017

Samsung’s biosimilar etanercept, Brenzys, is listed on the PBS in Australia with “A” flagging enabling substitution at the pharmacy level

2016

December 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.

September 12, 2016

Brenzys®(SB4)  is the first biosimilar etanercept to be approved in Canada.

July 22, 2016

Brenzys® (SB4) becomes the first biosimilar etanercept to be approved in Australia.

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.

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.

2015

September 7, 2015

Samsung Bioepis announces Brenzys® (SB4), biosimilar etanercept received approval in South Korea with launch intended late 2015/early 2016.

BioBlast® extract From September 7, 2015 to January 31, 2024