BioBlast®

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 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.

The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10^th 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.

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.

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.

The UK’s NICE published final draft guidance recommending adalimumab, etanercept and infliximab for the treatment of moderate rheumatoid arthritis on the NHS.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.

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 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.

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.

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

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

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 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. 

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.

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

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.

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

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

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

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

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

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 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.

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

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.

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.

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.

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.

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

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.

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.

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

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

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

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

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

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

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

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

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.

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.

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

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.

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.

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.

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

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

Lupin secures external funding for its etanercept biosimilars program.

Sandoz launches Erelzi® in Canada.

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

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).

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

Samsung Bioepis receives positive CHMP opinion for its  application for indication extension of Benepali® (etanercept) to include juvenile idiopathic arthritis and pediatric plaque psoriasis.

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

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

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.

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.

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