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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: adalimumab

2021

JP | Mochida and Ayumi launch 100mg/mL adalimumab biosimilar in Japan

November 25, 2021

Mochida Pharmaceutical and Ayumi Pharmaceutical announced the launch of high-dose 100mg/mL Adalimumab BS MA (adalimumab biosimilar) in Japan.

NZ | NZ’s Pharmac to transfer Principal Supply status to Amgevita® (biosimilar adalimumab)

November 17, 2021

Pharmac announced that it will transfer Principal Supply status from Humira® (adalimumab) to Amgevita® (biosimilar adalimumab) from 01 March 2022.

AU | AU’s PBAC publishes the outcomes from its July 2021 meeting

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.

FDA review of CHS-201 (proposed adalimumab biosimilar) advancing towards the target action date in December 2021

November 9, 2021

Coherus BioSciences reported its Q3 2021 financial results. Coherus announced that FDA review of CHS-201 (proposed adalimumab biosimilar) is advancing towards the target action date in December 2021. Coherus also disclosed that the FDA has accepted the BLA for its proposed toripalimab biosimilar for advanced nasopharyngeal carcinoma, with a target action date of April 2022.

Pfizer to launch citrate-free adalimumab in the US as early as 1 July 2023

November 2, 2021

Pfizer released its Q3 2021 results, reporting a 34% increase operationally in biosimilars. Pfizer announced that it plans to launch citrate-free Abrilada® (biosimilar adalimumab) in the US as early as 1 July 2023 in accordance with its agreement with AbbVie. Pfizer disclosed that it plans to seek interchangeable status for Abrilada® in December 2021.

US | FDA approves Cyltezo® (biosimilar adalimumab) as the first biosimilar designated as interchangeable with Humira® (adalimumab)

October 15, 2021

Boehringer Ingelheim announced that FDA has approved Cyltezo® (biosimilar adalimumab) as the first biosimilar designated as interchangeable with Humira® (adalimumab).   Cyltezo® is a 50 mg/mL “citrate free” (ie acetate buffered) product, and the “interchangeable” designation will be limited to only some of the Humira® products, unless FDA responds favourably to the citizen petition lodged by Boehringer Ingelheim in December 2020 requesting FDA to interpret the term “strength” in legislation in section 351(k) of the Public Health Service Act (42 U.S.C. 262(k) in a manner which would extend BI’s interchangeability designation to all formulations delivering the same amount of active (irrespective of concentration).  The FDA stated in a May 2021 interim response that it has been unable to made a decision on the CP to date “because it raises complex issues requiring extensive review and analysis by Agency officials”.

AU | Australian pharmacists raise concerns over proforma letters provided by AbbVie

October 9, 2021

The Australian reported that Australian pharmacists have raised concerns over proforma letters provided by AbbVie to prescribing doctors (specialist rheumatologists and gastroenterologists) and public hospital clinics instructing chemists to only dispense Humira® branded adalimumab rather than biosimilar adalimumab.

US | US District Court dismisses Humira® trade secrets lawsuit brought by AbbVie against Alvotech

October 8, 2021

The US District Court for the Northern District of Illinois dismissed the Humira® trade secrets lawsuit brought by AbbVie against Alvotech for lack of jurisdiction.

JP | Humira® receives additional approvals for high-dose regimen in Japan

September 27, 2021

AbbVie, Eisai Co and EA Pharma announced Humira® (adalimumab) has received additional approvals in Japan for its high-dose regimen in adults with ulcerative colitis and in a new regimen in paediatric patients.

EU | EU’s CHMP recommends the approval of AVT02 (proposed adalimumab biosimilar)

September 17, 2021

Alvotech announced that the EU’s CHMP has adopted a positive opinion recommending the approval of AVT02 (proposed adalimumab biosimilar).

Alvotech announces positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®

September 10, 2021

Alvotech announced positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®. Alvotech reported that no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference cohort.

US | US District Court refuses to dismiss AbbVie’s Humira® infringement suit

August 26, 2021

The US District Court for the Northern District of Illinois refused to dismiss AbbVie’s Humira® (adalimumab) infringement suit against Alvotech hf. The court found that AbbVie is not required to sue the US based subsidiary listed on the aBLA form, but could sue Icelandic company Alvotech hf.

NZ | NZ’s Pharmac considering changes to adalimumab funding arrangements

August 26, 2021

NZ’s Pharmac announced that it is considering awarding Principal Supply to Amgevita® (biosimilar adalimumab). Pharmac is seeking feedback on the proposed changes to the funding arrangements.

Progenity released its Q2 2021 financial results

August 12, 2021

Progenity released its Q2 2021 financial results. Progenity disclosed that it has recently produced a GMP drug substance batch for its adalimumab oral biotherapeutics delivery system (PGN-0B1).

New study reports on the safety and efficacy of BI695501 (biosimilar adalimumab)

August 10, 2021

A new study published in the The Lancet reported that the safety and efficacy of Boehringer Ingelheim’s BI695501 (adalimumab biosimilar) in patients with Crohn’s disease is similar to reference adalimumab.

Coherus Biosciences releases its Q2 2021 financial results

August 5, 2021

Coherus Biosciences released its Q2 2021 financial results. Coherus announced that its partner, Junshi Biosciences plans to submit the BLA for toripalimab for a number of indications later this quarter. Coherus also disclosed that it anticipates a mid-2022 target action date for its BLA for biosimilar ranibizumab, and confirmed it plans to launch its biosimilar adalimumab on or after 1 July 2023.

AbbVie releases Q2 2021 financial results

July 30, 2021

AbbVie released its Q2 2021 financial results, reporting US Humira® (adalimumab) net revenues increased 7.1%, but decreased internationally 12.6% on an operational basis. AbbVie attributed this decrease to biosimilar competition.

New study confirms safety and efficacy of Celltrion’s adalimumab biosimilar

July 22, 2021

A new study published in Rheumatology reported that the safety and efficacy of Celltrion’s CT-P17 (biosimilar adalimumab) were comparable after one year of treatment, including for patients who switched from reference adalimumab after 24 weeks.

UK | UK’s NICE recommends biologics for treatment of moderate RA

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.

Boditech Med receives export approval for AFIAS Adalimumab diagnostic kit

July 12, 2021

Boditech Med announced it has obtained export approval for AFIAS Adalimumab, a diagnostic kit which measures adalimumab levels in blood. The test is able to return a result within 10 minutes using whole blood on-site.

Alvotech reaches primary completion date in AmAb switching study

June 15, 2021

Alvotech announced it has reached the primary completion date in its switching study for AVT02 (proposed adalimumab biosimilar). Alvotech hopes to list AVT02 as an interchangeable adalimumab biosimilar in the US, which would allow for pharmacy substitution.

UK | UK’s NICE recommends biologics for moderate RA

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.

EU | Celltrion to launch Yuflyma® (biosimilar adalimumab) in the EU in June

May 31, 2021

The Korea Herald has reported that Celltrion will launch Yuflyma® in the EU in June.  Citing ‘industry sources’ and a Celltrion official, the article discloses that Celltrion will initially launch Yuflyma® in six EU countries including Spain, before launching in an additional 7 EU countries in Q3 2021, and 3 more in Q4 2021.

AbbVie to present new data on its immunology products

May 25, 2021

AbbVie announced it will present new data from a number of studies on its immunology products including Rinvoq® (upadacitinib), Skyrizi® (risankizumab) and Humira® (adalimumab) at the EULAR 2021 Virtual Congress of Rheumatology.

US | US House of Reps Oversight Committee publishes scathing report on Humira®

May 20, 2021

The US House of Representatives Committee on Oversight and Reform published a Drug Pricing Investigation Staff Report which was scathing regarding AbbVie’s conduct regarding the sale of its blockbuster drugs Humira® (adalimumab) and Imbruvica® (ibrutinib) in pursuing ‘a variety of tactics to increase drug sales while raising prices for Americans, including exploiting the patent system to extend its market monopoly, abusing orphan drug protections to further block competition, and engaging in anti-competitive pricing practices.’. 

AU | Alphapharm receives AU approval for adalimumab biosimilar

May 14, 2021

Alphapharm received approval for Hulio® (biosimilar adalimumab) in Australia.  Hulio® was approved in a 20mg/0.4mL solution for pre-filled syringe, 40mg/0.8mL solution for pre-filled syringe, and 40mg/0.8mL solution for pre-filled pen.  Viatris launched Hulio® in Canada and Japan in February this year.

Alvotech takes front foot approach and commences suit against AbbVie

May 11, 2021

Alvotech filed a federal lawsuit against AbbVie in the US District Court of the Eastern District of Virginia, seeking to clear patent barriers relating to biosimilar adalimumab, AVT02.  Alvotech alleges that AbbVie has sought to protect its product monopoly by ‘overwhelming’ Alvotech with 60+ patent claims with questionable validity.  Specifically, Alvotech alleges that AbbVie has acted improperly by:

  • patenting purported inventions that it does not use in the production of Humira®
  • seeking multiple patents on the same invention but as part of different patent families in a manner designed to cause confusion;
  • obtaining patents through inequitable conduct;
  • by seeking patents that cover Humira® already in the prior art; and
  • obtaining patents on purported inventions that AbbVie did not invent.

AbbVie’s Humira® still holds a monopoly in the US, despite biosimilars being available in the EU, Japan, Canada and Australia.

CA | Alberta expands biosimilar switching program

May 6, 2021

The Government of Alberta announced it has expanded its biosimilars switching program to include adalimumab for all originator indications except pediatric juvenial idiopathic arthritis. All adult patients on Humira® will be switched to Amgevita®, Hadlima®, Hulio®, Hyrimoz® or Idacio® by 01 May 2022.  This follows extensions made to biosimilar switching programs by British Columbia and New Brunswick last month.

CA | Amgen launches Amgevita® (biosimilar adalimumab) in Canada

May 4, 2021

Amgen launched Amgevita® (biosimilar adalimumab) in Canada. Amgevita® is available in 50mg/mL PFS and pen presentations and is citrate-free. Amgevita® will be reimbursed on the public drug plans in BC, Alberta, Ontario, Quebec, New Brunswick and Newfoundland.

Merck reports its vision for Organon

May 3, 2021

Merck reported the vision, focus and business model for its new standalone company, Organon.  Merck disclosed that Organon with have a direct sales presence in 58 markets, with key growth drivers in Organon’s biosimilars portfolio expected to be Renflexis® (biosimilar infliximab), Aybintio® (biosimilar bevacizumab) and Hadlima® (biosimilar adalimumab).

New study indicates bimekizumab is noninferior and superior to adalimumab

April 23, 2021

A new study sponsored by UCB Biopharma SPRL indicates that bimekizumab is noninferior and superior to adalimumab at 16 weeks in the treatment of plaque psoriasis.

Samsung Bioepis releases its Q1 2021 financial results

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.

Boehringer Ingelheim reports on Ph III adalimumab switching study

April 23, 2021

Boehringer Ingelheim announced results from a Ph III switching study of Cyltezo® (biosimilar adalimumab) with Humira® produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity and safety.

CA | BC expands its biosimilars switching program

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.

New AbbVie study reports upadacitinib is superior to adalimumab

March 31, 2021

A new AbbVie study published in the NEJM reports a 30mg dose of upadacitinib is superior to adalimumab in DMARD-refractory psoriatic arthritis (PsA). The percentage of patients with PsA who achieved an ACR20 response at week 12 was 78.5% of patients treated with 30 mg upadacitinib, compared to 65% of patients treated with adalimumab.

AU | CA | Samsung Bioepis launches Hadlima® (biosimilar adalimumab) in Australia and Canada

March 29, 2021

Samsung Bioepis announced on 29 March 2021 that it has launched Hadlima®, its 50mg/mL biosimilar adalimumab in Australia and Canada. Australia’s PBAC previously confirmed that Hadlima® would be PBS listed from 01 April 2021.

Alvotech denies AbbVie’s claims of trade secret piracy

March 26, 2021

Alvotech has disputed AbbVie’s claim filed in the Northern District of Illinois last week relating to AbbVie’s allegations of wrongdoing in the development of Alvotech’s biosimilar adalimumab product.  Alvotech notes “AbbVie waited over three years from the purported date of the alleged wrongdoing to file its case, doing so after the ex-AbbVie employee had already left Alvotech and without naming the ex-AbbVie employee as a defendant”, suggesting that these latest accusations may be part of AbbVie’s broader strategy to delay biosimilar competition.

AU | AU’s PBAC makes changes to adalimumab listings

March 26, 2021

A number of changes have been made to the PBS listings of adalimumab. From 1 April:

  • The Amgen, Merck/Samsung, Sandoz and Fresenius 50mg/ml products will be PBS listed and A flagged against the 50mg/ml Humira formulations for all approved indications; and
  • Humira 100mg/ml 20mg and 40mg products will be listed and A flagged against the 50mg/ml Humira formulations, and the 50mg/ml Humira product will be phased out over 12 months but cannot be prescribed after 1 April (ie the pharmacies will honour scripts written prior to 1 April).
  • Humira 100mg/ml 80mg syringe and pen products will be PBS listed but will not be A flagged as they are not considered equivalent to the “original” Humira formulation/product.

JP | LG Chem receives approval for its biosimilar adalimumab in Japan

March 25, 2021

Korea Biomedical Review reported that LG Chem has received approval from Japan’s Health Ministry for its biosimilar adalimumab. The product will be commercialised by Mochida Pharmaceuticals.

KR | Samsung Bioepis enters biosimilar adalimumab agreement with Yuhan

March 15, 2021

Korea Biomedical Review reported that Samsung Bioepis has entered an agreement with Yuhan Corp for the commercialisation of Adalloce™ (biosimilar adalimumab) in South Korea. Adalloce™ is marketed in Europe as Imraldi®.

EMA publishes details of Celltrion’s Yuflyma® (biosimilar adalimumab)

March 3, 2021

The EMA published the EPAR for Celltrion’s Yuflyma®. The EPAR revealed that Celltrion’s product is citrate-free, but is not buffer-free, with other ingredients including ‘acetic acid, sodium acetate trihydrate, glycine, polysorbate 80 and water for injections’.

AU | NZ | Cipla expands biosimilar partnership with Alvotech for ANZ

March 2, 2021

Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).

US | Coherus reports Q420 and Full Year 2020 financial results

February 24, 2021

Coherus released its Q420 and Full Year 2020 financial results. Coherus reported it has captured 21% of the pegfilgrastim market and nearly 50% of the pre-filled syringe segment in the US. Additionally, Coherus announced it plans to file its BLA for its ranibizumab biosimilar mid-year 2021. Coherus also confirmed that it plans to launch its adalimumab biosimilar in the US on or after July 1, 2023.

AU | BR | EU | US | Fresenius Kabi announces it will launch its biosimilar adalimumab in Australia in Q2 2021

February 23, 2021

In its Q4 2020 investor presentation, Fresenius Kabi announced it will launch its biosimilar adalimumab in Australia in Q2 2021 and in Brazil in Q3 2021. Additionally, Fresenius Kabi announced it will launch its biosimilar pegfilgrastim in the US and the EU in Q3/4 2021. Fresenius Kabi’s biosimilar tocilizumab candidate is planned for launch in the US and the EU in 2023. An undisclosed autoimmune biosimilar is planned for a 2024 launch, and an oncology biosimilar in 2025.

CA | Viatris launches Hulio® (biosimilar adalimumab) in Canada

February 18, 2021

Viatris announced it has launched Hulio® (biosimilar adalimumab) in Canada. Hulio® is available in a 50mg/ml formulation (40mg/0.8mL) and is approved for all adalimumab indications.

CA | Fresenius Kabi launches Idacio® (biosimilar adalimumab) in Canada

February 18, 2021

Fresenius Kabi announced it has launched Idacio® (biosimilar adalimumab) in Canada. Idacio® is available in 50mg/ml formulation (40mg/0.8mL syringe, vial and pen presentations) and is approved for all Humira® indications.

CA | Sandoz launches Hyrimoz® (biosimilar adalimumab) in Canada

February 17, 2021

Sandoz announced that it has launched Hyrimoz®, its 50mg/mL biosimilar adalimumab in Canada. Hyrimoz® was approved by Health Canada in November 2020 with a full label. It was also previously launched in Europe in 2018.

US | FDA accepts Coherus’ BLA for biosimilar adalimumab

February 17, 2021

Coherus Biosciences announced the FDA has accepted the BLA for its biosimilar adalimumab candidate (CHS-1420). Coherus also announced that it plans to launch its product in the US on or after 01 July 2023. Coherus had previously disclosed that its license with AbbVie would commence in the US in December 2023.

JP | Fujifilm and Mylan launch Hulio® (biosimilar adalimumab) in Japan

February 15, 2021

Fujifilm Kyowa Kirin Biologics and Mylan announced the launch of Hulio® in Japan. Hulio® is available in a 40mg/0.8mL syringe and pen presentation (indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, ankylosing spondylitis, Entero-Behcet’s Disease and Crohn’s Disease), and a 20mg/0.4mL syringe (indicated for juvenile idiopathic arthritis). This is the first adalimumab biosimilar to be launched in Japan.

EU | Celltrion’s Yuflyma® (biosimilar adalimumab) approved in the EU

February 15, 2021

Celltrion announced it received EC marketing authorisation for Yuflyma® (biosimilar adalimumab) across all indications. This is the first approval of a high concentration, low-volume biosimilar adalimumab. The EPAR is yet to be published by EMA.

Celltrion discusses its adalimumab biosimilar

February 4, 2021

In an interview with the Centre for Biosimilars the head of Celltrion’s Medical and Marketing Division, HoUng Kim PhD, discussed its high concentration, citrate-free adalimumab biosimilar. Kim announced that Celltrion has completed patent settlements in the US and is approaching settlements in Europe. Kim also revealed that the application for Celltrion’s US biosimilar adalimumab product was filed in November 2020.

US | Vizient releases Pharmacy Market Outlook

January 27, 2021

Health care performance improvement company Vizient releases its Winter 2021 Pharmacy Market Outlook. Vizient projected that the greatest price increases to members would occur in Humira® (adalimumab), with a 7.5% price increase predicted over the next 18 months. Adalimumab also topped the list of greatest total spend by product among Vizient members, followed by pembrolizumab, rituximab, infliximab, ustekinumab, nivolumab and denosumab. New figures also showed trastuzumab biosimilars have captured a significant market share, contributing to 39% of cost to members in September 2020.

2020

EU | Celltrion receives positive opinion from CHMP for Yuflyma®(biosimilar adalimumab)

December 10, 2020

Celltrion receives a positive opinion from the EU’s CHMP for its proposed 100mg/mL adalimumab biosimilar Yuflyma® for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis. If approved, this will be the first registered high concentration, citrate-free adalimumab biosimilar anywhere in the world.

CN | China’s NMPA approves Henlius’ adalimumab

December 7, 2020

Shanghai Henlius Biotech announces its adalimumab biosimilar HLX03 has been approved by China’s NMPA for rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

Novartis provides updates on Sandoz biosimilar candidates

November 24, 2020

Novartis released its annual report ‘Meet Novartis Management 2020‘. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis has also indicated it  has planned launches for biosimilar adalimumab and natalizumab in 2021-2023 and denosumab in 2024-2026.

CA | Health Canada grants NOC for Hulio®

November 24, 2020

BGP Pharma receives a NOC from Health Canada for Hulio® (biosimilar adalimumab).

EU | US | EMA and FDA accept Alvotech’s adalimumab application

November 19, 2020

Alvotech announces the FDA and EMA have accepted its regulatory submissions for AVT02 (proposed adalimumab biosimilar). Approval is expected in the US in September 2021 and Q4 2021 in the EU.

CA | Health Canada issues NOCs for Amgevita®

November 4, 2020

Amgen receives three Notices of Compliance (NOC) from Health Canada relating to Amgevita® (50mg/mL biosimilar adalimumab).

Celltrion announces results of Ph III trials of proposed AmAb biosimilar

November 2, 2020

Celltrion announces the results of Ph III studies of CT-P17 (proposed adalimumab biosimilar) demonstrate comparable efficacy and safety against reference adalimumab in rheumatoid arthritis.

CA | Health Canada issues NOC for Idacio®

October 30, 2020

Fresenius Kabi receives a Notice of Compliance relating to its biosimilar adalimumab (50mg/mL), Idacio®.

US | Two amicus briefs filed in support of Humira® antitrust legislation

October 12, 2020

Two amicus briefs were filed in the 7th Circuit Court of Appeals in support of the plaintiffs in the Humira® (adalimumab) antitrust legislation UFCW Local 1500 Welfare Fund v AbbVie, Inc. The US Public Interest Research Group jointly filed its brief with Consumer Action, arguing that AbbVie’s conduct was anticompetitive, and that the District Court’s decision should be overturned. In its brief, the Open Markets Institute argued that the District Court should have evaluated AbbVie’s patent applications and lawsuits as a series of sham filings.

Oxford commences Ph II AmAb trials in COVID-19 patients

September 30, 2020

The University of Oxford announces it has commenced Ph II trials of adalimumab as a treatment for patients with COVID-19. The trial will enrol up to 750 patients from community care settings throughout the UK and is funded by the COVID-19 Therapeutics Accelerator, an initiative set up by Wellcome and Mastercard. The trial will assess Hyrimoz® (biosimilar adalimumab), developed by Sandoz.

CN | China’s NMPA approves Sulinno®

September 3, 2020

Innovent Biologics announces China’s NMPA has approved Sulinno® for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.

IN | Cadila launches Cadalimab® in India

August 28, 2020

Cadila Pharmaceuticals launches Cadalimab® (biosimilar adalimumab) in India. Cadalimab® is available in 40mg/0.8mL injection and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis. This is the fourth biosimilar launch in India by Cadila within 2 months following Bevaro® (biosimilar bevacizumab), Ritucad® (biosimilar rituximab) and NuPTH® (biosimilar teriparatide).

AU | PBAC adopts positive recommendation for expanded Hadlima® indications

August 21, 2020

PBS publishes the outcomes of the July 2020 meeting including a positive recommendation for Merck’s application to broaden out the PBS reimbursed indications for its Hadlima® (biosimilar adalimumab). Merck’s Hadlima® was first granted PBS listing in 2018 for rheumatoid arthritis only. The expanded recommendation follows Sandoz’s positive recommendation for Hyrimoz® earlier this year, which included the same indications as Humira®.

New study indicates ixekizumab demonstrates greater joint and skin improvement than adalimumab

August 10, 2020

Healio reports a new article published in the Annals of the Rheumatic Diseases showed that ixekizumab demonstrated significantly greater joint and skin improvement than adalimumab among patients with psoriatic arthritis (PsA). The 52 week SPIRIT trial assessed 566 adults with PsA who had not yet been treated with a biological disease-modifying anti-rheumatic drugs.

US | Celltrion preparing US AmAb application

August 7, 2020

Celltrion releases its Q2 FY20 earnings report.  Celltrion reported that it is “preparing” its US approval application for CT-P17 (biosimilar adalimumab candidate), following the filing of its application in the EU in March this year. 

Study reports comparability of Cyltezo® and Humira®

July 27, 2020

The Centre for Biosimilars reports a study presented at the American Academy of Dermatology’s Virtual Meeting Experience 2020 demonstrates the safety, efficacy and immunogenicity of Boehringer Ingelheim’s Cyltezo® (biosimilar adalimumab) is comparable to AbbVie’s Humira®.

EU | Humira® sales negatively impacted by prescription of alternative mechanism of action agents

July 20, 2020

Spherix reports that the EU market for AbbVie’s Humira® has been negatively impacted by gastroenterologists increasingly prescribing alternative mechanism of action agents, including Stelara® (ustekinumab) and Entyvio® (vedolizumab) for ulcerative colitis (UC) and Crohn’s disease (CD) and the increased prescription of adalimumab biosimilars. These increases have come at a cost to AbbVie, with use of Humira® in UC and CD decreasing in the EU.

US | FDA approves Hulio®

July 9, 2020

Mylan announces FDA approval of Hulio® (biosimilar adalimumab) for PFS and auto-injector presentations.

JP | Fujifilm receives AmAb manufacturing and marketing approval in Japan

June 29, 2020

Fujifilm Kyowa Kirin Biologics announces manufacturing and marketing approval in Japan for FKB237 (adalimumab biosimilar). This product was developed in partnership with Mylan and has been marketed as Hulio® in 20 countries across Europe.

AU | TGA approves Idacio®

June 17, 2020

Fresenius Kabi receives Australian approval for Idacio® (biosimilar adalimumab) with identical indications as Humira®, in 40mg vial, PFS and pen.

Hetero releases results of AmAb trials

June 11, 2020

A new study published in BMC Rheumatology reports that Hetero’s biosimilar adalimumab Mabura® was effective and well tolerated in comparison to Humira® in patients with active rheumatoid arthritis.

US | US District Court rules AbbVie’s conduct was not illegal, but prevented competition

June 9, 2020

The Big Molecule Watch reports that a US District Court Judge ruled AbbVie’s conduct in relation to its blockbuster Humira® (adalimumab), while preventing competitors from reaching the market in the US, was not illegal. The action was filed against AbbVie by a number of parties including the City of Baltimore and a pension for Police Officers, and alleges that by amassing a ‘patent thicket’ and settling litigation with competitors which prevented them launching in the US, AbbVie had engaged in conduct which breached federal and state antitrust laws.

DE | Fresenius Kabi and Medac reach AmAb deal

May 29, 2020

Fresenius Kabi announces it has signed an agreement with Medac to cooperate in Germany in the area of treatments for rheumatic illnesses. From 01 June 2020, Medac’s sales representatives will be able to offer Fresenius Kabi’s adalimumab biosimilar Idacio. Medac is already a provider of methotrexate, a product which is often used in combination with adalimumab.

CN | Shanghai Henlius Biotech’s AmAb under NDA review in China

May 27, 2020

Shanghai Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.

Alvotech announces results of Ph I and III AmAb trials

May 12, 2020

Alvotech releases the results of two studies for AVT02, a proposed adalimumab biosimilar, announcing both studies met their primary endpoints. Alvotech announced that the Ph I clinical study demonstrated the PK similarity of AVT02 to the reference product Humira®, while the Ph III study demonstrated equivalent efficacy compared to Humira® in patients with moderate-to-severe chronic plaque psoriasis.

Novartis reports on adalimumab and secukinumab comparison study

May 8, 2020

Results of the Novartis’ EXCEED study comparing adalimumab and secukinumab for the treatment of PSA (psoriatic arthritis) were released.  Researchers reported no statistically significant superiority between secukinumab and adalimumab as first-line treatment of psoriatic arthritis, but secukinumab was associated with a higher treatment retention rate than adalimumab.

AbbVie reports decline in global Humira® sales

May 1, 2020

AbbVie released its Q1 2020 financial results, reporting a 13.7% increase in US sales of Humira® from Q1 2019. In global markets, Humira® sales were down 14.9%, a decline that was attributed to biosimilar competition.

Alvotech and DKSH announce AmAb deal

March 24, 2020

Alvotech and DKSH announce an exclusive license partnership for the commercialisation of AVT02 (adalimumab candidate) in 36 emerging countries in South-East Asia. Under the agreement, Alvotech will be responsible for development and supply and DKSH will be responsible for registration and commercialisation.

Hisun completes Ph III AmAb trials

March 12, 2020

Hisun Pharmaceuticals completes Phase III trials of HS016 (adalimumab). Researchers concluded that HS016 was similar to adalimumab in terms efficacy and safety in the treatment of ankylosing spondylitis.

EU | Celltrion submits AmAb application in the EU

March 9, 2020

Celltrion submits its application for CT-P17 (adalimumab) to the EMA. If approved, CT-P17 will be the first high-concentration adalimumab available.

US | AbbVie outlines defence strategy for Humira® competition

February 18, 2020

AbbVie outlines defence strategy for Humira® (adalimumab) competition in the US market. CEO Gonzalez stated that AbbVie’s strategy will be based on the strategy already employed in Europe and other markets, while also admitting that global competition was much more aggressive than had been predicted.

EU | Pfizer delays Amsparity® launch in EU

February 13, 2020

Despite receiving CHMP approval earlier this month, Pfizer has announced it does not currently plan to launch Amsparity® (adalimumab) in the EU, citing unfavourable market conditions. 

US | AbbVie warns of Humira® profit erosion in 2023

January 21, 2020

AbbVie management acknowledge losses will be felt when biosimilar adalimumab products launch in the US market in 2023. Drawing from an international profit erosion of 45-48% for Humira® in 2019, AbbVie’s CEO Gonzalez warned stakeholders that biosimilar competition in the US would further impact profits. Gonzalez also noted that the erosion rate in the US would not be directly comparable to European markets as it would be heavily impacted by negotiations with managed care and pharmacy benefit managers.

HK | TW | Mundipharma and Samsung announce AmAb deal

January 13, 2020

Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung’s adalimumab candidate in Taiwan and Hong Kong.

CN | Bio-Thera launches Qletli® in China

January 10, 2020

Bio-Thera launches adalimumab biosimilar, Qletli® in China following Nov 2019 approval.

US | US Court of Appeals affirms invalidity of three Humira® patents

January 7, 2020

US Court of Appeals affirms US PTAB’s earlier decision, which invalidated three AbbVie patents (8,889,135, 9,017,680 and 9,073,987) as obvious. The initial challenges to these patents were brought by Coherus and Boehringer Ingelheim, who have since settled with AbbVie, leaving the appeal to be defended by the USPTO.

2019

EU | CHMP recommends approval of Amsparity®

December 13, 2019

Pfizer receives positive CHMP opinion for its biosimilar adalimumab product.

Boehringer announces results of Ph III trials of AmAb

December 13, 2019

Boehringer Ingelheim has released the results of its Ph III trials of its biosimilar adalimumab, announcing the product demonstrated non-inferior efficacy and similar safety profile to the originator.

EU | Coherus and Amgen announce AmAb settlement

November 27, 2019

Coherus and Amgen settle suit over adalimumab. Notice of the agreement has been approved by a US Federal Court, however no further details about the settlement have been published. This dispute arose when Amgen launched Amgevita® in Europe in 2018 (manufactured in the US), with Coherus alleging the product infringed 4 of its own patents. 

US | FDA approves Abrilada®

November 15, 2019

FDA approves Pfizer’s adalimumab biosimilar Abrilada®. This product will not be launched until November 2023, under the terms of Pfizer’s agreement with AbbVie entered into in November 2018.

CN | China’s NMPA approves Qletli®

November 7, 2019

Bio-Thera announces China’s National Medicinal Products Administration has approved its biosimilar adalimumab, Qletli® for the treatment of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

CN | Biogen acquires rights to Samsung’s Imraldi®

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.

AbbVie reports decrease in Humira® revenues due to biosimilar competition

November 1, 2019

AbbVie releases Third-Quarter results, showing an overall decrease in Humira® revenues of 3.7% due to biosimilar competition. While Humira® revenues continued to increase in the US by 9.6%, internationally revenues decreased by 33.5%.

US | Humira® identified in Report on Unsupported Price Increases

October 8, 2019

The Institute for Clinical and Economic Review releases its report on Unsupported Price Increases, highlighting AbbVie’s Humira® as one of the products with price increases which are unsupported by new clinical evidence. 

UK | NHS reports £110 million in AmAb savings

August 31, 2019

NHS announces saving of £110 million by using AmAb biosimilars since AbbVie’s Humira® lost patent protection in October 2018.

Innovent announces reults of Ph III AmAb trials

August 30, 2019

Results of Phase III trial of proposed adalimumab biosimilar demonstrate therapeutic equivalence in terms of efficacy, safety and immunogenicity. The results, published in the first issue of the Lancet Rheumatology, support Innovent’s bid to launch the first biosimilar adalimumab in China.

Momenta drops proposed AmAb biosimilar

August 2, 2019

Momenta announces it has dropped proposed AmAb biosimilar candidate, M923, citing changes in market opportunity due to patent litigation settlements.

Alvotech and Cipla announce AmAb deal

July 29, 2019

Alvotech and Cipla announce they have entered an exclusive arrangement relating to the commercialisation of AVT02, Alvotech’s biosimilar adalumimab.  Alvotech is responsible for development and supply of the product, while Cipla is responsible for registration and commercialisation. AVT02 is in Phase-3 clinical development with an expectation that applications will be filed with EMA and FDA by “early 2020”.

US | FDA approves Hadlima®

July 24, 2019

Samsung announces FDA approval of adalimumab biosimilar, Hadlima® for RA, JIA, PSA, Crohn’s, UC, PP and AS.  This is Samsung’s third biosimilar anti-TNF Ab approval in the US.  It will be marketed by Merck in the US, after 30 June 2023 pursuant to the terms of Samsung’s settlement with AbbVie.

Alvotech completes enrolment of Ph III AmAb trials

July 15, 2019

Alvotech announces completion of enrolment in Phase III trials of biosimilar adalimumab AVT02.  407 participants across Europe have enrolled, while Phase I PK trials are ongoing.

ES | EU | Mylan launches Hulio® in Spain

July 9, 2019

Mylan launches Hulio® in Spain following EC approval in September 2018.

Sandoz announces results of Hyrimoz® switching studies

June 14, 2019

Sandoz announces results of Hyrimoz® switching studies in patients with moderate-to-severe rheumatoid arthritis, announcing no clinically meaningful differences in safety, efficacy or immunogenicity.

EU | Imraldi dominates 46% share of EU AmAb biosimilar market

June 4, 2019

Samsung BioLogics announces Imraldi® dominates 46% share in European adalimumab biosimilar market.

AbbVie and Boehringer Ingelheim announce AmAb settlement

May 15, 2019

AbbVie announces global settlement with Boehringer Ingelheim. This is the 9th global deal AbbVie has entered into, with BI securing a US market entry date of 1 July 2023, after Amgen (31 Jan 2023) and Samsung Bioepis (30 Jun 2023), and before Mylan (31 Jul 2023), Fresenius Kabi and Sandoz (30 Sept 2023), Momenta Pharmaceuticals and Pfizer (20 Nov 2023), and Coherus BioSciences (15 Dec 2023). The agreement is royalty bearing, however no further details have been released.

EU | EMA approves Idacio®

April 3, 2019

Fresenius Kabi announces European Commission approval of biosimilar adalimumab, Idacio® for all indications. 

US | Baltimore files class action against AbbVie

April 2, 2019

The Mayor and City Council of Baltimore files additional class action against AbbVie, alleging that anti-competitive behaviour prevented the introduction of biosimilars and allowed AbbVie to demand ‘supra competitive prices’. Additionally, the complaint alleges that through the agreements reached with AbbVie, Amgen has been awarded a 5 month period with reduced competition as the only biosimilar available from January 2023.

Celltrion completes recruitment of Ph III AmAb trials

March 28, 2019

Celltrion announces completion of recruitment for Phase III clinical trials of biosimilar adalimumab.

US | UFCW Local 1500 Welfare Fund files class action against AbbVie, Amgen, Samsung, Mylan, Sandoz, Fresenius, Pfizer and Momenta

March 18, 2019

UFCW Local 1500 Welfare Fund, a grocery union, files class action against AbbVie, Amgen, Samsung Bioepis, Mylan, Sandoz, Fresenius Kabi, Pfizer and Momenta, alleging misconduct and antitrust violations. The union alleges that the hundreds of patents which protect Humira® and settlements reached which the other seven companies have resulted in a monopoly which has prevented any competition. The class action includes persons or entities who have purchased or paid for Humira® since January 1, 2017.

Alvotech commences Ph III AmAb trials

March 13, 2019

Alvotech commences Phase III trial of 100mg/mL adalimumab biosimilar. 400 participants will be enrolled across 30 sites in Europe in this comparability study.

AU | TGA approves Hyrimoz®

March 1, 2019

Sandoz obtains Sandoz Australian approval for biosimilar adalimumab Hyrimoz®. This is the third biosimilar adalimumab approval in Australia.

US | US court orders Boehringer to disclose AmAb launch plans

February 27, 2019

In ongoing litigation between Boehringer and AbbVie, the court has ordered Boehringer to release its plans for biosimilar adalimumab, Cytelzo®. Cytelzo® has been approved by the FDA but has not yet been launched.

EU | CHMP recommends granting approval of Fresenius Kabi’s AmAb

February 1, 2019

The CHMP recommends granting approval for two AmAb biosimilars, Idacio® and Kromeya®. Both products are indicated for RA, psoriasis, psoriatic athritis and Crohn’s disease.

AbbVie and Coherus announces AmAb settlement

January 25, 2019

Coherus announces an 8th global deal with AbbVie for the commercialisation of biosimilar AmAb, under which Coherus has global, non-exclusive license rights which are royalty bearing.  Coherus’ US rights commence on 15 Dec 2023, just under a month after Momenta’s & Pfizer’s.

2018

UK | NHS announces AmAb biosimilars deal

December 20, 2018

The NHS announces negotiations for the supply of adalimumab biosimilars have concluded with Amgen, Biogen, Mylan, Sandoz and AbbVie. This deal is predicted to save the NHS £300M per year.

EU | Pfizer withdraws EU AmAb application

December 5, 2018

Pfizer notifies the CHMP it wishes to withdraw its application for Fyzoclad®, biosimilar adalimumab, due to changes in the company’s strategy.  

AbbVie and Pfizer announce AmAb settlement

November 30, 2018

AbbVie announces a 7th global deal for biosimilar adalimumab. A non-exclusive royalty bearing license to Pfizer for AmAb will begin on 20 November 2023 in the US and on approval in the EU (no other dates disclosed).  Pfizer’s US launch date is the same as Momenta’s, 10 months after the first licensed biosimilar launch (Amgen).

CN | China’s NMPA accepts Innovent AmAb application

November 13, 2018

China’s National Medical Products Administration accepts Innovent’s application for biosimilar adalimumab. The application seeks approval for the treatment of ankylosing spondylitis, rheumatoid arthritis, and psoriasis.

AbbVie and Momenta announce AmAb settlement

November 6, 2018

AbbVie announces a 6th global deal for biosimilar AmAb, this time with Momenta.  Momenta has obtained a global royalty bearing licence beginning on 20 November 2023 for the US, and in the EU “on approval” (no other dates disclosed). Momenta will be able to launch in the US 10 months after Amgen, with Samsung, Mylan, Fresenius and Sandoz able to launch between June and September of 2023.

US | FDA approves Hyrimoz®

October 31, 2018

FDA approves Sandoz adalimumab biosimilar Hyrimoz® for treatment of rheumatoid arthritis, juvenile idiopathic arthitis, psoriatic arthritis, ankylosing spodylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

EU | Mylan launches Hulio® in EU

October 19, 2018

Mylan announces launch of Hulio®, biosimilar adalimumab in Europe.

AbbVie and Fresenius reach AmAb settlement

October 18, 2018

AbbVie and Fresenius separately announce global deal with Fresenius Kabi under which Fresenius has a US licence from 30 Sept 2023 (the same date as Sandoz), and may sell in EU on approval.  The deal is global, and different dates apply for other regions.  The Fresenius (and Sandoz) US launch date is 9 months after Amgen’s (31 Jan 2023), 3 months after Samsung Bioepis’ (30 Jun 2023), and 2 months after Mylan’s (31 Jul 2023).

EU | Sandoz, Samsung and Amgen launch AmAb products in the EU

October 15, 2018

Sandoz, Samsung and Amgen launch their biosimilar adalimumab products (Hyrimoz®, Imraldi® and Amgevita®) pursuant to the terms of their IP licences with AbbVie.  Mylan also has EMA approval (but no AbbVie EU IP licence) but has indicated an intention to launch their biosimilar Hulio® on or after 16 October.  Similarly Boehringer has no IP licence, but we have no indication of BI’s launch plans for approved Cyltezo®

AbbVie and Sandoz announce global settlement

October 11, 2018

AbbVie announces global settlement with Sandoz, under which Sandoz receives a royalty-bearing, non-exclusive licence to AbbVie’s Humira® patents from 30 Sep 2023 in the US, and 16 Oct 2018 in EU (and other dates elsewhere).  The EU date is the same as AbbVie has given to Amgen and Samsung Bioepis (note – Mylan has no EU license), and the US date is later than those given to Amgen (31 Jan 2023), Samsung Bioepis (30 Jun 2023) and Mylan (31 Jul 2023).

Momenta announces new focus on AmAb biosimilar

October 1, 2018

Momenta announces an end to its strategic review, revealing a sole focus to advance a Humira® biosimilar. Momenta announced it will file a BLA with the FDA and is working to find a commercialisation partner for the product. 

US | FDA accepts Samsung’s AmAb BLA

September 27, 2018

FDA accepts BLA for biosimilar adalimumab. 

EU | EMA approves Hulio®

September 20, 2018

Mylan announces the EU approval of Hulio®, biosimilar adalimumab licensed from Fujifilm in April 2018.

CN | China’s CNDA accepts Bio-Thera’s AmAb BLA

August 24, 2018

Bio-Thera announces that the CNDA (China National Drug Administration) has accepted its BLA for biosimilar adalimumab BAT1406.  This is expected to be Bio-Thera’s first drug approval.

Celltrion commences Ph I and III AmAb trials

August 7, 2018

Celltrion announces Phase I and III trials for AmAB biosimilar across 75 sites in 8 European nations, expected to be completed by 2020.

AU | PBAC to list Amgevita and Hadlima as ‘a-flagged’

July 28, 2018

AU’s PBAC has confirmed that Amgen and Samsung’s biosimilar adalimumab (respectively Amgevita and Hadlima) will be “A-flagged”, enabling pharmacy substitution.

EU | EMA approves Sandoz AmAb

July 27, 2018

Sandoz announces EC approval for Hyrimoz®, biosimilar adalimumab for use in all indications.

EU | CHMP adopts positive opinion on Mylan AmAb

July 27, 2018

Mylan and Fujifilm announce positive response from CHMP for biosimilar adalimumab for use in all indications. 

US | AbbVie and Mylan announce global settlement

July 17, 2018

AbbVie announces a global settlement with Mylan under which Mylan acknowledges Humira® AbbVie’s patents are valid, and Mylan receives a royalty-bearing, non-exclusive global license (excluding Europe) from 31 July 2023.  This date will not be accelerated by entry of Amgen or Samsung Bioepis.

US | Grassley and Klobuchar urge FTC to investigate Humira settlements

June 22, 2018

US Senators Chuck Grassley and Amy Klobuchar urge FTC to investigate ‘pay-for delay’ settlements, in particular AbbVie’s Humira settlements, for anti-competitive behaviour.  Of particular concern is investigating whether these settlements are keeping biosimilars out of the hands of patients.

Fresenius announces Ph III AmAb results

June 14, 2018

Fresenius reports the results of its Ph III studies for biosimilar adalimumab MSB11022 in moderate-to-severe chronic plaque psoriasis at the European League Against Rheumatism’s Annual European Congress of Rheumatology.

EU | CHMP adopts positive opinion for Sandoz AmAb

May 31, 2018

CHMP recommends granting marketing authorisation for 3 biosimilar AmAbs developed by Sandoz – HalimatozHefiya and Hyrimoz.

Coherus confirms 2022 AmAb launch date

May 10, 2018

Coherus BioSciences confirms its 2022 target launch date for CHS-1420, biosimilar adalimumab.  Commercial partnering options are being considered.

EU | Mylan and Fujifilm announce AmAb deal

April 11, 2018

Mylan announces EU deal with Fujifilm (with other territories still under negotiation) relating to Fujifilm’s biosimilar adalimumab, filed in EMA on 18 May 2017 with approval expected “late 2018”.  Mylan’s existing partner Biocon will receive payments under the deal.

AbbVie and Samsung announce global settlement

April 5, 2018

Samsung announces a royalty-bearing, global settlement with AbbVie enabling Samsung to launch its SB5 biosimilar adalimumab in Europe from 16 October 2018 and in the US from 30 June 2023.  The EU date is the same as AbbVie gave Amgen’s in its September 2018 global settlement, but the US date is 5 months later than Amgen’s licensed date of 31 Jan 2023.  SB5 is registered in EU as Imraldi® and in AU as Hadlima®.

AU | TGA approves Hadlima®

January 24, 2018

The second biosimilar AmAb, Samsung Bioepis’ Hadlima®, is registered on the ARTG in 2 different dosages.

US | FDA accepts Sandoz’s AmAb for review

January 16, 2018

Sandoz announced the FDA has accepted for review its application under s351(k) for biosimilar adalimumab.   

AbbVie confirms it does not expect AmAb biosimilar competition until 2022

January 11, 2018

At the JP Morgan conference, Richard Gonzalez, (chairman of the board and CEO of AbbVie) confirms that AbbVie does not expect biosimilar competition for Humira® until 2022.

IN | Glenmark launches biosimilar AmAb in India

January 4, 2018

Glenmark announces the launch of biosimilar adalimumab (developed by Zydus, marketed as Adaly®), in India.

2017

EU | EMA approves Boehringer Ingelheim’s Cyltezo®

November 10, 2017

EMA approves BI’s Cyltezo® (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases in adults and children.

AU | TGA approves Amgevita®

November 9, 2017

The first biosimilar adalimumab, Amgen’s Amgevita®, is registered on the ARTG in 3 different dosages.

Boehringer Ingelheim publishes results from AmAb switching study

November 9, 2017

BI publishes results from switching study showing efficacy and safety maintained in patients who switched from Humira® to biosimilar Cyltezo®.

Coherus publishes Ph III AmAb results

November 7, 2017

Coherus publishes phase 3 studies on proposed biosimilar adalimumab, CHS-1420.

Hexal publishes new AmAb study

November 7, 2017

Hexal/Parexel publishes results of PK, immunogenicity and safety studies relating to proposed adalimumab biosimilar GP2017. 

US | AbbVie and Amgen settle AmAb dispute

September 28, 2017

Amgen and AbbVie settle global patent disputes regarding adalimumab, and Amgen secures a royalty-bearing, non-exclusive license to AbbVie’s Humira® IP.  Amgen’s license commences in the US on 31 Jan 2023, in most EU countries on 16 Oct 2018, and “on other dates in various countries in which AbbVie has intellectual property.”

KR | Samsung receives approval to launch AmAb in South Korea

September 20, 2017

Samsung says it has approval to sell biosimilar adalimumab in South Korea, but will delay launch due to patent expiry.

EU | CHMP gives positive approval for Boehringer Ingelheim’s AmAb

September 15, 2017

BI receives positive CHMP opinon on Cyltezo®, biosimilar to adalimumab.  Approval is expected in Q4/17.

Sandoz announces 51 week results for AmAb biosimilar

September 14, 2017

Sandoz announces at the EADV results from 51 week clinical study confirming that Sandoz’s biosimilar adalimumab matches Humira® in safety and efficacy profile.

US | PTAB denies institution of Coherus’ IPR petitions

September 7, 2017

PTAB denies institution of Coherus Biosciences’ 4 IPR petitions against AbbVie’s 9,085,619 relating to the Humira® formulation.

US | FDA approves Cyltezo®

August 29, 2017

Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for Cyltezo® (adalimumab-adbm), a biosimilar to Humira®.  This is the first biosimilar from BI to be FDA approved.  According to the release:

  • Cyltezo® is not yet commercially available due to the active patent litigation between Boehringer Ingelheim and AbbVie.

  • EMA is expected to provide an opinion on BI’s EU application in 2017.

EU | EMA approves Imraldi®

August 24, 2017

Imraldi®, Biogen/Samsung’s adalimumab biosimilar approved in the EU.

US | AbbVie commences BPCIA proceedings against Boehringer Ingelheim

August 2, 2017

AbbVie commences BPCIA proceedings against Boehringer Ingelheim for Humira® (adalimumab) biosimilar in the District Court of Delaware, alleging infringement of 8 patents: (8,926,975; 9,018,361; 9,090,867; 9,096,666; 9,255,143; 9,266,949; 9,272,041; and 9,546,212), a subset of the 74 listed under § 262(l)(3)(C) and § 262(l)(7).  Two of the patents in suit overlap with the 10 patents in suit in the earlier Delaware proceedings commenced against Amgen in August 2016 (8,663,945; 8,911,964; 8,916,157; 8,961,973; 8,986,693; 9,096,666; 9,220,781; 9,272,041; 9,359,434; and 9,365,645) which has been set down for hearing on 4 November 2019.   AbbVie alleges those 10 patents are a subset of 61 patents in dispute, the remainder of which could be addressed in phase 2 BPCIA litigation.

Boehringer Ingelheim commences AmAb interchangeability studies

July 28, 2017

BI commences interchangeability studies between biosimilar BI695501 and Humira 40mg/0.8ml, with the results expected in second half of 2019.

EU | CHMP gives positive opinion for Samsung’s AmAb

June 23, 2017

Imraldi®, Samsung’s adalimumab biosimilar (SB5) receives positive opinion from CHMP in EMA.

EU | EC accepts MA for Fujifilm’s AmAb

May 22, 2017

Fujifilm announces EC has accepted its MA for biosimilar adalimumab (FKB327) which Fujifilm filed in April 2017.   Clinical trials were conducted in RA and commenced in Dec 2014.

US | EMA approves Amgevita®

March 23, 2017

EMA approves Amgen’s biosimilar adalimumab Amgevita® with a full indication set.  This is the first EU approval for biosimilar adalimumab.

UK | UK High Court hands down AmAb decision

March 3, 2017

UK High Court hands down decision in Samsung v Abbvie.

EU | CHMP gives positive opinion for Amgen’s AmAb

January 27, 2017

CHMP (Committee for Medicinal Products for Human Use) for EMA gives positive opinion for Amgen’s biosimilar adalimumab.

2016

EU | Amgen/Allergan submit adalimumab application to EMA

December 2, 2016

Amgen/Allergan submit EMA application for biosimilar adalimumab.

US | FDA approves Amgen’s Amjevita® (biosimilar adalimumab)

September 23, 2016

FDA approves Amgen’s biosimilar to adalimumab, Amjevita™ (adalimumab-atto), 11 months after Amgen’s application was filed.

EU | EMA accepts Samsung’s AmAb application

July 18, 2016

Samsung announces the EMA has accepted for its review its application for adalimumab biosimilar.

US | FDA Advisory Committee to review Amgen’s biosimilar AmAb candidate

June 13, 2016

Amgen announces FDA Advisory Committee Meeting to review ABP 501 (biosimilar adalimumab).  FDA has set a Biosimilar User Fee target action date of 25 September 2016.

US | FDA Advisory Committee reviews Amgen adalimumab BLA

June 13, 2016

FDA’s Arthritis Advisory Committee reviews data supporting Amgen’s BLA for ABP 501 (biosimilar adalimumab).

UK | Samsung files UK revocation suit

March 24, 2016

Samsung Bioepis files suit in the UK to remove Abbvie patents regarding adalimumab.

2015

US | Amgen submits BLA for biosimilar adalimumab

November 25, 2015

Amgen submits BLA under s351(k) pathway for ABP 501 (proposed adalimumab biosimilar).