Humira® | Adalimumab | AbbVie

November 24, 2020

24 Nov 20 | CA | BGP Pharma receives a NOC from Health Canada for Hulio® (biosimilar adalimumab).

 

19 Nov 20 | US, EU | Alvotech | 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.

 

04 Nov 20 | CA | Amgen | Amgen receives three Notices of Compliance (NOC) from Health Canada relating to Amgevita® (50mg/mL biosimilar adalimumab).

 

03 Nov 20 |  All | Celltrion | 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.

 

30 Oct 20 | CA | Fresenius Kabi | Fresenius Kabi receives a Notice of Compliance relating to its biosimilar adalimumab (50mg/mL), Idacio®.

 

12 Oct 20 | US | AbbVie | 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.

 

30 Sep 20 | All | Sandoz | 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.

 

03 Sep 20 | CN | Innovent | Innovent Biologics announces China's NMPA has approved Sulinno® for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.

 

28 Aug 20 | IN | Cadila Pharmaceuticals | 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).

 

21 Aug 20 | AU | Merck | 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®.

 

10 Aug 20 | All | 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.

 

07 Aug 20 | EU | Celltrion | 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. 

 

27 Jul 20 | All | Boehringer Ingelheim | The Centre for Biosimilars reports a study presented at the American Academy of Dermatology's Virtual Meeting Experience 2020 which demonstrated the safety, efficacy and immunogenicity of Boehringer Ingelheim's Cyltezo® (biosimilar adalimumab) is comparable to AbbVie's Humira®.

 

20 Jul 20 | EU | AbbVie | 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.

 

09 Jul 20 | US | Mylan | Mylan announces FDA approval of Hulio® (biosimilar adalimumab) for PFS and auto-injector presentations.

 

29 Jun 20 | JP | Fujifilm Kyowa Kirin Biologics | 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.

 

17 Jun 20 | AU | Fresenius Kabi | Fresenius Kabi receives Australian approval for Idacio® (biosimilar adalimumab) with identical indications as Humira®, in 40mg vial, PFS and pen.

 

11 Jun 20 | All | Hetero | 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.

 

09 Jun 20 | US | AbbVie | 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.

 

29 May 20 | EU | Fresenius Kabi, Medac | 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.

 

27 May 20 | CN | Henlius Biotech | Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.

 

12 May 20 | All | Alvotech | 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.

 

08 May 20 | All | Novartis | 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.

 

01 May 20 | All | AbbVie | 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.

 

24 Mar 20 | All | Alvotech, DKSH | 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.

 

12 Mar 20 | CN | Hisun | 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.

 

09 Mar 20 | EU | Celltrion | Celltrion submits its application for CT-P17 (adalimumab) to the EMA. If approved, CT-P17 will be the first high-concentration adalimumab available.

 

18 Feb 20 | All | AbbVie | 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.

 

13 Feb 20 | EU | Pfizer | 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. 

 

21 Jan 20 | All | AbbVie | 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.

 

13 Jan 20 | Mundipharma, Samsung | Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung's adalimumab candidate in Taiwan and Hong Kong.

 

10 Jan 20 | CN | Bio-Thera | Bio-Thera launches adalimumab biosimilar, Qletli® in China following Nov 2019 approval.

 

07 Jan 20 | US | AbbVie | 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.

 

13 Dec 19 | EU | Pfizer | Pfizer receives positive CHMP opinion for its biosimilar adalimumab product. 

 

13 Dec 19 | All | Boehringer Ingelheim | 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.

 

27 Nov 19 | US | Coherus, Amgen | 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. 

 

15 Nov 19 | US | Pfizer | 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 (see below). 

 

07 Nov 19 | CN | Bio-Thera | 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.

 

06 Nov 2019 | CN | Biogen, Samsung Bioepis | Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilar ranibizumab and aflibercept for major markets world side including the US, Canada, Europe, Japan and Australia. Biogen has also acquired exclusive commercialisation rights for its anti-TNF portfolio, including BENEPALI® (etanercept), FLIXABI® (infliximab) and IMRALDI® (adalimumab), in China.  Under the agreement, Biogen will make one $100 million upfront payment, with up to $210 million payable at additional development, regulatory and sales-based milestones.

 

01 Nov 19 | All | AbbVie | 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%.

 

08 Oct 19 | US | AbbVie | 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. 

 

31 Aug 19 | UK | AbbVie, Amgen, Samsung Bioepis, Sandoz, Mylan | NHS announces saving of £110 million by using AmAb biosimilars since AbbVie's Humira® lost patent protection in October 2018.

 

30 Aug 19 | All | Innovent Biologics | 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.

 

02 Aug 19 | All | Momenta | Momenta announces it has dropped proposed AmAb biosimilar candidate, M923, citing changes in market opportunity due to patent litigation settlements.

 

29 Jul 19 | US | Alvotech/Cipla | 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".

 

24 Jul 19 | US | Samsung Bioepis/Merck | 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.

 

15 Jul 19 | All | Alvotech | Alvotech announces completion of enrolment in Phase III trials of biosimilar adalumimab AVT02.  407 participants across Europe have enrolled, while Phase I PK trials are ongoing.

 

09 Jul 19 | EU | Mylan | Mylan launches Hulio® in Spain following EC approval in September 2018.

 

14 Jun 19 | All | Sandoz | Sandoz announces results of Hymrioz® switching studies in patients with moderate-to-severe rheumatoid arthritis, announcing no clinically meaningful differences in safety, efficacy or immunogenicity.

 

04 Jun 19 | EU | Samsung BioLogics, Biogen | Samsung BioLogics announces Imraldi® dominates 46% share in European adalimumab biosimilar market

 

15 May 19 | Global | AbbVie BI | 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.

 

03 Apr 19 | EU | Fresenius Kabi |Fresenius Kabi announces European Commission approval of biosimilar adalimumab, Idacio® for all indications. 

 

02 Apr 19 | US | AbbVie | 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.

 

28 Mar 19 | All | Celltrion | Celltrion announces completion of recruitment for Phase III clinical trials of biosimilar adalimumab.

 

18 Mar 19 | US | AbbVie | 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.

 

13 Mar 19 |All | Alvotech | Alvotech commences Phase III trial of 100mg/mL adalimumab biosimilar. 400 participants will be enrolled across 30 sites in Europe in this comparability study.

 

01 Mar 19 | AU | Sandoz |Sandoz obtains Sandoz Australian approval for biosimilar adalimumab Hyrimoz®. This is the third biosimilar adalimumab approval in Australia.

 

27 Feb 19 | US | Abbvie, Humira | 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.

 

01 Feb 19  | EU | Fresenius Kabi | 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.

 

25 Jan 19 | Coherus Biosciences & AbbVie | 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.

 

20 Dec 18 | UK | Amgen/Biogen/Mylan/Sandoz/AbbVie | 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.

 

05 Dec 18 | EU | Pfizer | Pfizer notifies the CHMP it wishes to withdraw its application for Fyzoclad®, biosimilar adalimumab, due to changes in the company's strategy.  

 

30 Nov 18 | All | Pfizer | 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).

 

13 Nov 18 | CN | Innovent | 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.

 

6 Nov 18 | All | Momenta | 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. 

 

31 Oct 18 | US | Sandoz | 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.

 

19 Oct 18 | EU | Mylan/Fujifilm | Mylan announces launch of Hulio®, biosimilar adalimumab in Europe.

 

18 Oct 18 | All | Fresenius Kabi | 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).

 

15 Oct 18 | EU | Sandoz, Amgen, Samsung | Sandoz, Samsung and Amgen launched 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® 

 

11 Oct 18 | All | Sandoz | 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). 

 

01 Oct 18 | US | Momenta | Momenta announces end to strategic review, revealing a sole focus to advance Humira biosimilar. Momenta announced they will file a BLA with the FDA and is working to find a commercialisation partner for the product. 

 

27 Sep 18 | US | Samsung Bioepis | FDA accepts BLA for biosimilar adalimumab. 

 

20 Sep 18 | EU | Mylan & Fujifilm Kyowa Kirin Biologics | Mylan announces the EU approval of Hulio®, biosimilar adalimumab licensed from Fujifilm in April 2018.

 

24 Aug 18 | CN | Bio-Thera Solutions | 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.

 

7 Aug 18 | EU | Celltrion | Celltrion announces Phase I and III trials for AmAB biosimilar across 75 sites in 8 European nations, expected to be completed by 2020.

 

28 Jul 18 | AU | Amgen & Merck/Samsung | AU's PBAC has confirmed that Amgen and Samsung's biosimilar adalumimab (respectively Amgevita and Hadlima) will be "A-flagged", enabling pharmacy substitution.

 

27 Jul 18 | EU | Sandoz | Sandoz announces EC approval for Hyrimoz®, biosimilar adalimumab for use in all indications.

 

27 Jul 18 | EU | Mylan, Fujifilm Biologics| Mylan and Fujifilm announce positive response from CHMP for biosimilar adalimumab for use in all indications. 

 

17 Jul 18 | All | Mylan | 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.

 

22 Jun 18 | US | AbbVie | 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.

 

14 Jun 18 | All | Fresenius Kabi| Fresenius reports the results of its ph3 studies for biosimilar adalimumab MSB11022 in moderate-to-severe chronic plaque psoriasis at the European League Against Rheumatism's Annual European Congress of Rheumatology.

 

31 May 2018 | EU | Sandoz | CHMP recommends granting marketing authorisation for 3 biosimilar AmAbs developed by Sandoz - Halimatoz, Hefiya and Hyrimoz.

 

10 May 2018 | All | Coherus BioSciences | Coherus BioSciences confirms its 2022 target launch date for CHS-1420, biosimilar adalimimab.  Commercial partnering options are being considered.

 

11 Apr 2018 | EU | Mylan Fujifilm Kyowa Kirin Biologics |  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.  

 

5 Apr 2018 | All | Samsung Bioepis | 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®.

 

24 Jan 2018 | AU | Samsung Bioepis | The second biosimilar AmAb, Samsung Bioepis' Hadlima®, is registered on the ARTG in 2 different dosages.

 

16 Jan 2018 | US | Sandoz | Sandoz announced the FDA has accepted for review its application under s351(k) for biosimilar adalimimab.   

 

11 Jan 2018 | All | AbbVie | 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. Read more 

 

04 Jan 2018 | IN | Glenmark/Zydus | Glenmark announces the launch of biosimilar adalimumab (developed by Zydus, marketed as Adaly®), in India.  

 

13 Nov 2017 | EU | Boehringer Ingelheim | BI announces EMA approval of Cyltezo®, adalimumab biosimilar for the treatment of multiple chronic inflammatory diseases in adults and children. Read more

 

09 Nov 2017 | AU | Amgen | The first biosimilar adalimumab, Amgen's Amgevita®, is registered on the ARTG in 3 different dosages.

 

07 Nov 2017 | All | Coherus Biosciences | Coherus publishes phase 3 studies on proposed biosimilar adalimumab, CHS-1420.  Read more

 

07 Nov 2017 | All | Hexal AG/Parexel| Hexal/Parexel publishes results of PK, immunogenicity and safety studies relating to proposed adalimumab biosimilar GP2017.  Read more

 

06 Nov 2017 | All |Boehringer Ingelheim | BI  claims publishes results from switching study showing efficacy and safety maintained in patients who switched from Humira® to biosimilar Cyltezo®.  Read more

 

28 Sep 2017 | All | Amgen | 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."  Read AbbVie's release here, and Amgen's release here.

 

20 Sep 2017 | KR | Samsung Bioepis | Samsung says it has approval to sell biosimilar adalimumab in South Korea, but will delay launch due to patent expiry.  Read more

 

15 Sep 2017 | EU | Boehringer Ingelheim |  BI receives positive CHMP opinon on Cyltezo®, biosimilar to adalimumab.  Approval is expected in Q4/17.  Read more

 

14 Sep 2017 | All | Sandoz | Sandoz announces at the EADV results from 51 week clinical study confirming that Sandoz’s biosimilar adalimumab matches Humira® in safety and efficacy profile.  Read more

 

7 Sep 2017 | US | Coherus Biosciences | PTAB denies institution of Coherus Biosciences' 4 IPR petitions against AbbVie’s 9,085,619 relating to the Humira® formulation. Read more

 

29 Aug 2017 | US & EU | Boehringer Ingelheim | 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. Read more

 

24 Aug 2017 | EU | Biogen/Samsung | Imraldi®, Biogen/Samsung’s adalimumab biosimilar approved in the EU.  Read more


2 Aug 2017 | US | AbbVie/Boehringer Ingelheim | 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. 

 

23 Jun 2017 | EU | Samsung Bioepis | Imraldi®, Samsung’s adalimumab biosimilar (SB5) receives positive opinion from CHPM in EMA.  Read more

 

July 2017 | All | Boehringer Ingelheim | BI commences interchangeability studies between biosimilar BI695501 and Humira 40mg/0.8ml, with the results expected in second half of 2019.  Read more

 

22 May 2017 | EU | Fujifilm Kyowa Kirin Biologics | Fijifilm 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.

 

23 Mar 2017 | EU | Amgen | EMA approves Amgen's biosimilar adalimumab Amgevita® with a full indication set.  This is the first EU approval for biosimilar adalimumab.

 

3 Mar 2017 | UK | Samsung/Abbvie | decision handed down by UK High Court in Samsung v Abbvie.  Read more.  Read the decision here.

 

27 Jan 2017 | EU | Amgen |  CHMP (Committee for Medicinal Products for Human Use) for EMA gives positive opinion for Amgen’s biosimilar adalimumab.  Read more

 

18 Jul 2016 | EU | Samsung Bioepis | Samsung's EU application for adalimumab biosimilar accepted for review by EMA.  Read more

 

13 Jun 2016 | US | Amgen | 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.  Read more

 

2 Dec 2016 | EU | Amgen/Allergan | Amgen/Allergan submit EMA application for biosimilar adalimumab.  Read more

 

23 Sep 2016 | US | Amgen | FDA approves Amgen's biosimilar to adalimumab, Amjevita™ (adalimumab-atto), 11 months after Amgen's application was filed.

 

13 Jun 2016 | US | Amgen | FDA’a Arthritis Advisory Committee review data supporting Amgen’s BLA for ABP 501 biosimilar adalimumab.  Read more

 

24 Mar 2016 | UK | Samsung Bioepis | Samsung Bioepis files suit in the UK to remove Abbvie patents regarding AmAb.  Read more

 

25 Nov 2015 | US | Amgen | Amgen submits BLA under s351(k) pathway for ABP 501, biosimilar adalimumab.  Read more

 

 

 

 

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Biosimilars Bulletin 

November 9, 2020

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