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Home / News / BioBlast®

EXPLORE OUR

BioBlast®

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: ustekinumab

2024

March 9, 2024

On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States.   

For its Humira® biosimilar (adalimumab/SB5), Samsung Bioepis presented further information relating to its Phase 4 (switching) study results, which formed the basis of its sBLA seeking interchangeability filed in November 2023.  Results from the same trials were published in Ocular Immunology and Inflammation in January 2024, and in the BMJ Open Opthalmology in December 2023.  Hadlima™ is FDA approved and has been supplied in the US since 1 July 2023 under a licence from AbbVie entered into in 2018. 

For SB17, biosimilar to Janssen’s Stelara® (ustekinumab), Samsung Bioepis presented the Phase 3 results for SB17 with switching studies, which demonstrated efficacy, safety, and immunogenicity for 52 weeks.  These results were presented at ECCO last month. 

SB5/Hadlima™ is commercialised in the US by Organon.  SB17 will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreement  inked in September 2023.   

March 5, 2024

Johnson and Johnson (J&J) and Janssen have filed a Motion to Dismiss a class action brought by several US health insurers alleging the companies unlawfully delayed biosimilar competition for Stelara® (ustekinumab) in the US.  J&J/Janssen argue that the alleged facts do not meet the standard of unlawful exclusionary conduct. 

The insurers filed the class action in the US District Court of East Virginia on 7 December 2023, alleging that the companies would lose exclusivity for Stelara® in the US on 25 September 2023 upon expiration of the relevant composition patent, and implemented a scheme to unlawfully prolong patent protection.   

March 4, 2024

Amgen announced that Wezlana™ (ustekinumab injection) and Wezlana™ (ustekinumab for injection, solution for intravenous infusion), biosimilar to Janssen’s Stelara®, is now available in Canada.  Wezlana™ is the first biosimilar to be approved by Health Canada for all Stelara® indications, but the second ustekinumab Canadian launch following the launch of  the first ustekinumab biosimilar (Jamteki™) in Canada by JAMP Pharma on 1 March 2024.   

Jamteki™ was developed by Alvotech and was approved by Health Canada in November 2023. 

March 1, 2024

On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada.  Jamteki was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding ustekinumab. 

Jamteki was developed by Alvotech and is JAMP Pharma’s second biosimilar launch in Canada in two years, following the Canadian launch of Simlandi® (adalimumab) biosimilar of AbbVie’s Humira® (adalimumab) in 2022.  The approved presentations for Jamteki™ are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

February 29, 2024

On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch its Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in the USA from February 2025.  The FDA previously accepted for review Biocon’s Biologics License Application for Bmab 1200. 

The settlement will result in the termination of the pending Inter Partes Review petition filed by Biocon in November 2023 against Janssen’s US method of treatment (severely active ulcerative colitis (UC)) patent 10,961,307 relating to Stelara® (ustekinumab). 

J&J and Janssen recently entered into ustekinumab settlements with Alvotech (launch dates of no later than 21 February 2025 (US), May 2024 (Japan), late July 2024 (EU) and Q1 2024 (Canada)), BioPharma (US launch date of 15 May 2025), Samsung Bioepis (US launch date from 22 February 2025), Celltrion (US launch date of 7 March 2025), Fresenius Kabi and Formycon (US launch date no later than 15 April 2025), and Amgen (US launch date no later than 1 January 2025).  To date, only Amgen has obtained FDA approval for its ustekinumab biosimilar, with its Wezlana® approved in October 2023. 

February 23, 2024

On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s Stelara®) at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) in Stockholm, Sweden.  The results demonstrate SB17 is highly similar to Stelara® in structural, physicochemical, and biological attributes.  On 25 February 2024, CHMP provided a positive recommendation for SB17.   

The medicine will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreemententered in September 2023 

February 22, 2024

On 22 February 2024, EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Samsung Bioepis’s Pyzchiva® (ustekinumab biosimilar).  Pyzchiva® is recommended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease in adults.  Pyzchiva® is intended to be supplied as 45 mg and 90 mg solutions for injection and a 130 mg solution for infusion.  

Pyzchiva® will be commercialised by Sandoz pursuant to a deal entered into in September 2023, between Sandoz and Samsung Bioepis for SB17 which covers the US, Canada, EEA, Switzerland and the UK. 

February 19, 2024

According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement.  The applications for PBS listing additions or amendments that the PBAC will consider at its March 2024 meeting include the following: 

New Listings  Amendment Applications  
Janssen-Cilag’s Stelara® (ustekinumab)  Sanofi-Aventis’s Dupixent® (dupilumab) 
Amgen’s Wezlana® (ustekinumab)  Bristol-Myers Squibb’s Opdivo® (nivolumab) 
Bayer’s Eylea® (aflibercept)  Merck’s Erbitux® (cetuximab) 
AstraZeneca’s Enhertu® (trastuzumab deruxtecan)  AbbVie’s Humira® (adalimumab) 
Celltrion’s Vegzelma® (bevacizumab)   
Celltrion’s Yuflyma® (adalimumab)   
AstraZeneca’s Saphnelo® (anifrolumab)   
Roche’s Tecentriq® (atezolizumab)   
UCB’s Bimzelx® (bimekizumab)   

 

 

 

 

 

 

 

In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to AbbVie’s Skyrizi® (risankizumab), and Novartis’s Cosentyx® (secukinumab). 

February 15, 2024

Alvotech announced that it has settled with Johnson & Johnson in the European Economic Area (EEA), Japan and Canada for its ustekinumab biosimilar, AVT04, and has provided guidance on its proposed launch dates in these regions.  AVT04 received regulatory approval in January 2024 in Europe, in September 2023 in Japan and in November 2023 in Canada.  The products will be marketed by Stada (as Uzpruvo®) in Europe from late July 2024, by Fuji Pharma in Japan (as Ustekinumab BS (F)) from May 2024, and by JAMP in Canada (as Jamteki®) from Q1 2024. 

Alvotech’s applications for AVT04 elsewhere around the world are pending, including in the US.   

In June 2023, Alvotech and Teva announced a US settlement with J&J relating to ustekinumab, with a market entry date of no later than 21 February 2025.   

February 13, 2024

A paper published in the journal BioDrugs reported the results of a Phase III study conducted in Eastern Europe and the Republic of Korea comparing the efficacy, safety, pharmacokinetics and immunogenicity of Celltrion’s CT-P43 with Janssen’s Stelara® (ustekinumab).  The study, conducted in 509 patients with moderate to severe plaque psoriasis, demonstrated equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles. 

On 5 February 2024, Rani Therapeutics published positive topline results from its phase I clinical trial on RT-111, an oral formulation of CT-P43.   

February 5, 2024

On 5 February 2024, Rani Therapeutics published positive topline results from its phase I clinical trial regarding RT-111, a RaniPill® capsule containing Celltrion’s ustekinumab biosimilar, CT-P43 (biosimilar to Janssen’s Stelara®).  The study shows that RT-111 was well-tolerated and delivered ustekinumab with high bioavailability. 

In June 2023, Rani Therapeutics announced that it expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar (RT-105), following their earlier collaboration on ustekinumab (CT-P43). 

January 22, 2024

The Therapeutic Goods Administration (TGA) has approved Amgen’s Wezlana®, the first approved biosimilar to Janssen’s Stelara® (ustekinumab), in Australia.  The vial and pre-filled syringe for subcutaneous injection have been approved to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease (CD) and ulcerative colitis (UC).  The vial for IV infusion is indicated for CD and UC.

The FDA approved Wezlana® as the first biosimilar to Stelara® on 31 October 2023.

January 19, 2024

Alvotech announced that its facility in Iceland received a form 483 from the FDA with only one observation.  The inspection started on 10 January 2024 and has concluded.  Alvotech said it will provide a response to the FDA in the coming days, and that the observation is “readily addressable”.  The company believes it is in a position to receive FDA approval for AVT02 (adalimumab, biosimilar to AbbVie’s Humira®) and AVT04 (ustekinumab, biosimilar to Janssen’s Stelara®) by their respective goal dates of 24 February 2024 and 16 April 2024.

The European Commission granted marketing authorisation for AVT04 under the brand name Uzpruvo® – the first EU-approved biosimilar to Stelara® – on 10 January 2024.

January 10, 2024

Alvotech and STADA announced the European Commission (EC) has granted centralised marketing authorisation (MA) for Uzpruvo® (AVT04), the first EU-approved biosimilar to Janssen’s Stelara® (ustekinumab).  The marketing authorisation is valid in all European Economic Area countries, including the 27 European Union Member States as well as in Iceland, Liechtenstein, and Norway.  The announcements state the approval ‘paves the way’ for market entry as soon as possible after expiry of a European Supplementary Protection Certificate (SPC) for Stelara® in July 2024.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Uzpruvo® (AVT04) on 10 November 2023.

January 4, 2024

Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115, its proposed biosimilar to Janssen’s Stelara®.

DMB-3115 was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas exclusive licensing rights worldwide excluding certain Asian countries, in an agreement announced in 2021.  Accord BioPharma will be responsible for US commercialisation.

In the same announcement, Accord announced that in October 2023 it reached a settlement with Janssen that would allow Accord to launch DMB-3115 in the US no later than 15 May 2025, pending FDA approval.

2023

December 7, 2023

Carefirst and another Blue Cross/Blue Shield licensee have brought class action proceedings against Johnson & Johnson (J&J) and Janssen alleging that the companies unlawfully delayed the introduction of biosimilar competition for its Stelara® ustekinumab product onto the US market.  The complaint alleges that J&J would lose exclusivity for Stelara® in the US on 25 September 2023 upon expiration of the relevant composition patent, and that J&J delayed biosimilar competition through a series of unlawful acts to unlawfully prolong patent protection for Stelara® well beyond September 2023.

The acts alleged in the Class Action include defrauding the US Patent and Trademark Office into incorrectly issue a patent to the use of ustekinumab to treat ulcerative colitis, acquiring the company Momenta, which held patents to manufacturing methods for ustekinumab, and suing or threatening suit of would-be biosimilar entrants for patent infringement. 

November 30, 2023

Samsung announced that has signed a settlement and licence agreement with Johnson & Johnson settling all pending US patent litigation between the companies, with a licence to Samsung to commercialise its Stelara (ustekinumab) biosimilar SB17 in the US from 22 February 2025.

Samsung and J&J subsidiary Janssen previously made reference to a settlement (without reference to the licence date) in their joint motion dated 3 August 2023, to terminate Samsung’s Inter Partes Review (IPR) challenging Janssen’s US patent 10 961 307.

Samsung’s BLA for SB17 is under review with the FDA and if approved will be commercialised in the US by Sandoz.

J&J has also entered into ustekinumab settlements with Celltrion (with a US licence date of 7 March 2025), Fresenius Kabi and Formycon (with a US licence date no later than 15 April 2025), Alvotech and Teva (with US licence date no later than 21 February 2025) and Amgen (with a US licence date no later than 1 January 2025).

November 29, 2023

Bio-Thera Solutions announced that its phase III study of BAT2206 demonstrated it is highly similar to Janssen’s Stelara® (ustekinumab) in patients with moderate to severe plaque psoriasis.  Bio-Thera confirmed it will present the results at a future medical meeting or in a publication.

On 16 June 2023, Bio-Thera entered a distribution agreement for BAT2206 in Brazil.  In 2021 Bio-Thera entered into a licence agreement with Hikma for the US (with option to add Europe) and with Pharmapark for Russia and other CIS countries.

November 28, 2023

Alvotech reported unaudited financial results for the first nine months of 2023.  Results included product revenue of US$29.8 million in 2023 compared to US$11.1 million for the same period in 2022, and R&D expenses of US$152.8 million compared to US$133.1 million in 2022.  The 2023 revenue consisted of European and Canadian sales of AVT02, Alvotech’s Humira® (adalimumab) biosimilar.

Alvotech also announced that it has resubmitted its BLA for AVT04 Stelara® (ustekinumab) biosimilar, which the FDA has accepted for review with a BsUFA goal date of 16 April 2024.  It also reported highlights including the FDA’s acceptance for review of its resubmitted BLA for AVT02 with a goal date of 24 February 2024, as well as marketing approvals for AVT04 in Canada and Japan, and a positive CHMP opinion in Europe.

November 22, 2023

Biocon Biologics filed an Inter Partes Review (IPR) petition against Janssen’s US patent no. 10,961,307 relating to Stelara® (ustekinumab).  Biocon Biologics is challenging all 34 claims of the patent, relating to methods of treating ulcerative colitis with ustekinumab.

On 9 August 2023, the USPTO Patent Trial and Appeal Board terminated Samsung Bioepis’s IPR challenging the ‘307 patent following Samsung and Janssen’s joint motion for termination on the basis that the parties had resolved the dispute.

November 22, 2023

A Phase III study funded by Celltrion compared the efficacy and safety of its ustekinumab biosimilar CT-P43 to Janssen’s Stelara® (ustekinumab).  The study concluded that CT-P43 was equivalent in efficacy in treating patients with moderate to severe plaque psoriasis, and had comparable pharmacokinetic, safety and immunogenicity profiles to Stelara®. 

In April 2023, Celltrion filed an application in Australia seeking approval of CT-P43 for all Stelara® indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. 

November 21, 2023

On 21 November 2023, the Canadian Federal Court of Appeals dismissed Janssen’s appeal from a decision of the Federal Court upholding Canada’s Office of Submission and Intellectual Property (OSIP) refusal of Janssen’s application to list Canadian Patent 3113837 on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab).

The Federal Court decision was handed down in July 2023.

November 14, 2023

Alvotech and JAMP Pharma announced that Health Canada has granted marketing authorization for Jamteki™ (AVT04), the first approved biosimilar to Stelara® (ustekinumab) in Canada.  AVT04 was developed by Alvotech and will be marketed under the name Jamteki® by JAMP in Canada.  The approved presentations are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

This is the first approved ustekinumab biosimilar in Canda, and the second biosimilar to receive marketing authorisation in Canada under the exclusive commercialization partnership between Alvotech and JAMP Pharma (following Simlandi®, biosimilar to Abbvie’s Humira® (adalimumab)).  The companies announced their exclusive partnership for the commercialisation of five biosimilars in Canada in January 2020, which was expanded to seven biosimilars in October 2022.

November 10, 2023

Alvotech and its EU partner Stada announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for ustekinumab Uzpruvo (AVT04), biosimilar to Janssen’s Stelara®.  This is the first positive CHMP opinion for a Stelara® biosimilar.

The Alvotech and Stada MAA was accepted by the EMA in February 2023.

Under their 2019 strategic partnership for seven biosimilars, Alvotech is primarily responsible for developing and manufacturing AVT04, and Stada holds commercial rights within Europe.  In May 2023 Alvotech announced that it had terminated the Stada agreement with respect to three biosimilars (excluding ustekinumab), and entered into an agreement with Advanz for Europe for five biosimilars month.

November 9, 2023

A pre-filled pen presentation of Janssen-Cilag’s Stelara® (ustekinumab) injection (90mg/1mL and 45mg/0.5mL) has been listed on the Australian Register of Therapeutic Goods.

October 31, 2023

On 31 October 2023, the FDA approved Amgen’s Wezlana® (ustekinumab-auub), as the first FDA-approved biosimilar to Janssen’s Stelara®Wezlana is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis (each in both adults and paediatric patients six years and older), and the treatment of moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis (in adults)Wezlana® is a subcutaneous injection in a 45mg/0.5mL pre-filled syringe and a 45mg/0.5mL vial

October 26, 2023

It has been reported that the Munich Regional Court has issued a preliminary injunction against Formycon’s manufacture of FYB202, its Stelara® (ustekinumab) biosimilar, in Germany until expiry of Janssen’s SPC on its basic ustekinumab patent on 20 July 2024.  According to the reports, the decision reflected the arguments submitted by Janssen that in order to rely on the EU manufacturing waiver to export FYB202 before SPC expiry, Formycon was required to produce a relevant marketing authorisation in a country outside the EU in which the SPC was not in force, and had not done so.

FYB202 is not approved in the EU.  Formycon and its commercialisation partner Fresenius Kabi announced in September 2023 that their MAA for FYB202 has been accepted for review by the EMA.

October 15, 2023

An AbbVie sponsored phase 3 study evaluating risankizumab for treatment of Crohn’s disease shows that risankizumab performs better than ustekinumab in primary and secondary endpoints. The study compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn’s disease. The safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified. 

In November 2023, the Korean MFDS approved AbbVie’s Skyrizi® (risankizumab) to treat Chron’s disease. 

October 12, 2023

Alvotech announced that FDA has issued a Complete Response Letter (CRL) regarding its aBLA for AVT04, biosimilar to Janssen’s Stelara® (ustekinumab).  The letter relates to certain deficiencies that were conveyed following the FDA’s inspection of Alvotech’s Reykjavik facility in March 2023.  No other deficiencies were noted by the FDA.  Alvotech intends to resubmit the BLA for AVT04 to the FDA shortly.  This will likely trigger a new BsUFA date for Alvotech’s ustekinumab.

In June 2023 Alvotech and Teva (the exclusive commercialization partner for AVT04 in the US), reached a settlement and license agreement with Johnson & Johnson that grants an entry date for AVT04 in the US no later than 21 February 2025.

On 25 September 2023 Alvotech received approval in Japan for AVT04.

October 11, 2023

Samsung Bioepis presented new data on its SB17 (ustekinumab, biosimilar to Janssen’s Stelara®) and Imraldi® (adalimumab, biosimilar to AbbVie’s Humira®) at the European Academy of Dermatology and Venereology (EADV) Congress.  The SB17 phIII study demonstrates that SB17 has equivalent efficacy and comparable safety and PK to Stelara® up to week 28 in patients with moderate to severe plaque psoriasis.  The Imraldi® four-year follow up study indicates that Imraldi can be started or transitioned from AbbVie’s Humira® (adalimumab) in patients with moderate-to-severe psoriasis.

On 11 September 2023, Sandoz and Samsung Bioepis entered an exclusive commercialisation agreement for SB17 in the US, Canada, EEA, Switzerland and the UK.

September 29, 2023

Formycon and its commercialisation partner Fresenius Kabi announced that the EMA has accepted for review their MAA for FYB202, biosimilar to Johnson & Johnson’s Stelara® (ustekinumab).

In February 2023, Fresenius Kabi and Formycon AG announced they had reached a global agreement to commercialise FYB202. Under the agreement, Fresenius has exclusive commercialisation rights in key global markets, whilst Formycon is responsible for development and registration.  Formycon acquired the rights to FYB202 from Athos in May 2022.

September 25, 2023

Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received marketing approval for AVT04 (ustekinumab), a biosimilar to Janssen’s Stelara®, from the Japanese Ministry of Health, Labor and Welfare.  Alvotech reported that, based on publicly available information this is the first ustekinumab biosimilar approved in Japan, and is also the first biosimilar approved under its agreement with Fuji which covers the commercialisation of seven biosimilars in total in Japan.

Alvotech and Fuji Pharma announced their exclusive agreement for the commercialisation of a Stelara® biosimilar in Japan in April 2019.

September 19, 2023

Korea Biomed reported that Rani Therapeutics has begun its phase I clinical trial for oral ustekinumab (RT-111) using Celltrion’s CT-P43 (ustekinumab), biosimilar to Janssen’s Stelara®.  Rani will evaluate pharmacokinetics and safety of RT-111 in up to 55 participants.

On 5 June 2023, Rani Therapeutics announced that it has expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar RT-105, following their previous collaboration on an ustekinumab biosimilar.

September 11, 2023

Sandoz and Samsung Bioepis announced they have entered an exclusive agreement to develop and commercialise SB17 (ustekinumab, biosimilar to Janssen’s Stelara®) in the US, Canada, EEA, Switzerland and the UK.  Others details of the deal are confidential.

This follows a confidential settlement in August 2023 between Samsung Bioepis and Janssen which resolved all pending disputes between the parties.  In that same month, Samsung Bioepis and Janssen filed a joint motion to terminate Samsung Bioepis’ IPR against Janssen’s US patent 10,961,307 filed 2 months earlier.

September 1, 2023

Business Korea reported that Celltrion filed an application with Australia’s Therapeutic Goods Administration (TGA) for approval of CT-P43, its biosimilar to Janssen’s Stelara® (ustekinumab).   Celltrion applied for approval of all Stelara® indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Celltrion submitted its aBLA for CT-P43 to the US FDA in June 2023 (and reached a settlement and licence agreement with Johnson & Johnson (J&J) permitting Celltrion to launch CT-P43 in the US on 7 March 2025), and submitted its MAA to EMA in May 2023.

August 31, 2023

Alvotech announced in its 2023 Q2 Earnings Presentation that it has resubmitted its interchangeable BLA for AVT02, biosimilar to AbbVie’s high concentration Humira® (adalimumab). The company did not disclose the BsUFA date but anticipated launch in 2024.

The FDA issued a complete response letter (CRL) for Alvotech’s interchangeable BLA on 28 June 2023, noting issues at Alvotech’s facility in Reykjavik, Iceland.

Alvotech also reported that AVT04, its biosimilar to Stelara®, is filed and pending approval in 7 markets including U.S, EU, Japan, and Canada, and it is expecting some approvals to occur before end of 2023.

Alvotech published its financial results on 30 August 2023.

August 29, 2023

The Korea Herald reported that Dong-A ST submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for its Stelara® biosimilar DMB-3115.  DMB-3115 was jointly developed by Dong-A and Meiji Seika Pharma, and will be commercialised in Europe by the Intas subsidiary Accord Healthcare.

Dong-A published the results of its global Ph III trials of DMB-3114 in January 2023.

August 25, 2023

Korea Biomedical Review reported that Celltrion has finalised an agreement with Johnson & Johnson (J&J) permitting Celltrion to launch CT-P43, its biosimilar to Stelara®, in the US on 7 March 2025.  Celltrion submitted its aBLA to the FDA in June 2023, and is seeking to obtain marketing authorisation in 2024.

This follows J&J’s ustekinumab settlements with Fresenius Kabi and Formycon (AG) (with a US licensed entry date no later than 15 April 2025), Alvotech and Teva (with a US licensed entry date no later than 21 February 2025), Amgen (with a licensed entry date no later than 1 January 2025) and with Samsung (for an unknown licensed entry date).

Celltrion filed its MAA with the EMA for CT-P43 in May 2023.

August 9, 2023

The USPTO Patent Trial and Appeal Board has terminated Samsung Bioepis’s Inter Partes Review (IPR) challenging Janssen’s US patent 10,961,307 relating to Stelara® (ustekinumab).  The Board’s decision follows Samsung and Janssen’s joint motion, dated 3 August 2023, stating that parties have resolved the dispute and request termination.  The motion states that the parties have entered into  a confidential settlement to resolve all present disputes and to avoid any additional disputes regarding the patent.

Samsung filed the IPR on 21 June 2023, arguing all claims of the patent are invalid, citing (amongst other things) a Janssen clinical overview summary for a phase III clinical trial of ustekinumab.

Samsung also filed a notice of opposition to the grant of an Australian counterpart, AU application no 2019346134, on 12 July 2023.  Law firm Reddie & Grose filed a post-grant notice of opposition (presumed to be on behalf of an unnamed client) to the European counterpart, EP patent no 3883606, on 27 July 2023.

August 7, 2023

Fresenius Kabi and Formycon AG announced they reached a settlement in the US with Johnson & Johnson relating to their ustekinumab (FYB202), biosimilar to Stelara®.  As part of the agreement, Fresenius and Formycon can launch in the US “no later than 15 April 2025”.  There were no proceedings on foot between the parties on foot in relation to FYB202 at the time of the settlement.

On 25 April 2023, Formycon announced the successful conclusion of its extended Phase I clinical study comparing the pharmacokinetics of FYB202 to Stelara®.   Formycon expects to file its BLA for FYB202 with the FDA later in 2023.

This settlement follows Johnson & Johnson’s previous settlement agreements with Amgen (for a licensed entry date no later than 1 January 2024), and with  Alvotech and Teva (for a licensed entry date for AVT04 in the US no later than 21 February 2025).

July 17, 2023

The Canadian Federal Court upheld a decision of Canada’s Office of Submission and Intellectual Property (OSIP) to refuse Janssen’s application to list Canadian Patent 3113837 (‘837 patent) on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab) OSIP refused the application as the ‘837 patent application was filed in Canada after the submissions.

Health Canada approved ulcerative colitis as an indication for Stelara® on 27 January 2020.

July 14, 2023

Intas Pharmaceuticals announced that the European Medicine Agency (EMA) has confirmed acceptance of its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (ustekinumab). The MAA was submitted by Accord Healthcare, a wholly owned subsidiary of Intas, on 23 June, and the EMA accepted the MAA submission on 14 July. Intas will commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada. 

On 22 July 2021, Intas Pharma announced it had signed a commercialisation agreement with Meiji and Dong-A St, under which Intas receives exclusive licensing rights to DMB-3115 worldwide excluding Japan, Korea and certain countries in Asia. 

July 12, 2023

A study comparing the efficacy, safety, tolerability, pharmacokinetics and immunogenicity between AVT04 (ustekinumab biosimilar) and Janssen’s Stelara® in patients with moderate-to-severe chronic plaque psoriasis (PsO) has been published.   The authors report that the study demonstrates the therapeutic equivalence between AVT04 and Stelara® in patients with moderate-to-severe chronic PsO, with similar safety and tolerability.

Alvotech announced clinical studies supporting biosimilarity and comparability of ATV04 and Stelara® on 17 March 2023, and the data was presented at the American Academy of Dermatology Annual Meeting on 17-21 March in New Orleans.

July 7, 2023

Aurobindo Pharma announced that its wholly owned subsidiary, CuraTeQ Biologics, has entered into an exclusive license agreement with the USA-based BioFactura Inc, to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara® (ustekinumab).  Ustekinumab is a recombinant monoclonal antibody for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

Under the terms of the agreement, CuraTeQ has exclusive license rights to commercialise BFI-751 in all major ‘regulated’ markets including the US, EU, UK, Canada, ANZ as well as in certain other markets, and the global manufacturing rights.  The product will be produced at CuraTeQ facilities in Hyderabad, India.  BioFactura has plans to begin a global Phase 3 trial of the product.  CuraTeQ intends to file the product in India and ‘emerging markets’ as early as 2024 and in the regulated markets beginning in 2026.

June 21, 2023

Samsung Bioepis has filed an IPR against Janssen’s US patent no. 10,961,307 (‘307 patent) relating to Stelara® (ustekinumab).  Samsung Bioepis argues that all claims of the ‘307 patent are invalid. Claims 1-4, 6-22, and 24-34 allegedly lack novelty and are anticipated by a Janssen clinical overview summary for a phase III clinical trial of ustekinumab (NCT-236).   All claims (1-34) are allegedly obvious in light of NCT-236 combined with a journal article and the Stelara® Prescribing Information.

On the same day, Samsung Bioepis filed an IPR against Alexion’s US patent no. 10,703,809 (’809 patent) relating to Soliris® (eculizumab).

On 12 June 2023 Alvotech and Teva announced they reached a settlement and licence agreement with J&J for AVT04 (Alvotech’s biosimilar to Stelara®) providing a licensed US launch date of no later than 21 February 2025, and on 22 May 2023 Amgen settled its Stelara® patent invalidity suit with Janssen in the US with a licensed US launch date of no later than 1 January 2025.

June 16, 2023

BusinessWire reports that Bio-Thera Solutions and Biomm SA have reached a licensing and supply agreement for BAT2206 (ustekinumab biosimilar).  Under the agreement, Biomm will have exclusive rights to distribute and market the product in Brazil.

We previously reported that Bio-Thera has previously entered into a licence agreement with Hikma for the US (with option to add Europe) and with Pharmapark for Russia and other CIS countries.

June 12, 2023

Alvotech and Teva announced they have reached a settlement and license agreement with Johnson & Johnson for AVT04, Alvotech’s biosimilar to Stelara® (ustekinumab).  J&J have granted a license entry date for AVT04 in the US no later than 21 February 2025. This is seven weeks after the reported date by which Amgen will be able to enter the market (1 January 2025) pursuant to its recent settlement with J&J.

On 6 January 2023, the FDA accepted the BLA for AVT04.

May 26, 2023

Korea Biomed has reported that Celltrion filed a marketing authorisatn application with the EMA for CT-P43, its biosimilar to Janssen’s Stelara® (ustekinemab).  Based on its phase III clinical trial in plaque psoriasis patients, which demonstrated similar efficacy, pharmacokinetic, and safety results between CT-P43 and Stelara®, Celltrion’s MAA sought approval for all Stelara® indications.  Celltrion confirmed it intends to seek approval in other key countries.

May 24, 2023

As previously reported, on 22 May 2023 the US District Court of Delaware dismissed Janssen’s patent infringement case against Amgen pertaining to its Stelara® (ustekinumab) biosimilar with prejudice on the basis that each party bears its own costs. The proposed orders made it clear that the parties had settled.

Reuters has since reported a statement by Amgen that the ustekinumab settlement will permit Amgen to sell its biosimilar “no later than January 1st, 2025”, suggesting the permitted launch date may be earlier than 1 January 2025.  As the API patent, one of six patents Janssen asserted in the proceedings, expires on 25 September 2023, we speculate that the agreed launch date is some time between 25 September 2023 and 1 January 2025.

May 22, 2023

The US District Court of Delaware has dismissed with prejudice Janssen’s patent infringement case against Amgen pertaining to its Stelara® (ustekinemab) biosimilar.  The parties agreed to dismiss the action with prejudice and each party will bear its own costs, expenses and attorney’s fees, and the proposed orders state the parties have agreed to settle the litigation.

Janssen commenced these proceedings against Amgen in November 2022 in relation to the API and MOT (UC) patents, and filed a motion for preliminary injunction in March 2023 (following dismissal of an earlier application due to non-compliance with the Court’s page limit requirements).

April 25, 2023

Formycon AG announced the successful conclusion of its extended Phase I clinical study comparing the pharmacokinetics of FYB202 and the reference drug Stelara® (ustekinumab).  This follows Formycon’s report in August 2022 that its Phase III studies demonstrated the comparable efficacy of FYB202 and Stelara® in patients with moderate-to-severe psoriasis vulgaris (plaque psoriasis).  Formycon stated FYB202 was bioequivalent to the reference drug Stelara® sourced in the EU as well as in the U.S. for all primary endpoint parameters.

EU and US regulatory submissions are still planned for the third quarter of 2023.  The product will be sold by Fresenius Kabi in key global markets.

April 12, 2023

Samsung filed a notice of opposition to the grant of Janssen’s Australian patent application AU2019346134 for the treatment of ulcerative colitis using an anti-IL12/IL23 antibody including Stelara® (ustekinumab).  Samsung’s Statement of Grounds and Particulars in support of the opposition are due to be filed with the Australian Patent Office by 12 July 2023.

We recently reported on Samsung’s Phase I clinical studies for SB17, its biosimilar to Janssen’s Stelara®.

March 17, 2023

Samsung announced that its Phase I clinical studies for SB17, biosimilar to Stelara® (ustekinumab), demonstrated pharmacokinetic bioequivalence and comparable safety, tolerability, and immunogenicity to reference ustekinumab in healthy volunteers.   Samsung will present these results at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, March 17-21, 2023.

March 17, 2023

Alvotech announced clinical studies support biosimilarity and comparability of its ATV04 (ustekinumab biosimilar) and Johnson & Johnson’s Stelara®.  The data will be presented at the American Academy of Dermatology Annual Meeting on 17-21 March in New Orleans.

EMA accepted Alvotech’s MAA for AVT04 in February 2023, and the FDA accepted a BLA for AVT04 in January 2023.

March 15, 2023

Janssen Biotech, Inc. has filed a redacted, public version of its opening brief in support of its motion for a preliminary injunction in proceedings relating to Amgen’s Stelara® (ustekinemab) biosimilar.  Janssen is seeking to enjoin Amgen, Inc. from manufacturing and using in commercial quantities, offering to sell, selling within the United States, or importing for commercial purposes into the United States its ABP 654 biosimilar product.  We previously reported that Janssen initially asserted two patents: US Patent Nos 6,902,734 (API) and 10,961,307 (methods of treating ulcerative colitis).  In its redacted brief Janssen states that while it has also asserted four ‘manufacturing’ patents, it is seeking a preliminary injunction for the duration of the proceedings based on only two of these: US Patent Nos 9217168 and 9475858.  We also previously reported that Janssen refiled its preliminary injunction motion after its original motion was denied because it did not comply with the court’s page limit requirements.

March 6, 2023

Janssen Biotech, Inc. has filed another motion for a preliminary injunction against Amgen regarding its ustekinemab biosimilar, after its original motion was denied by US District Court Judge Noreika on 2 March 2023.  Janssen is seeking to enjoin Amgen, Inc. from manufacturing and using in commercial quantities, offering to sell, selling within the United States, or importing for commercial purposes into the United States its ABP 654 biosimilar product. 

As we previously reported, Judge Noreika had denied Janssen’s motion because it did not comply with the court’s page limit requirements.  Her Honour orally ordered that the motion could be re-filed in compliance with court requirements. 

March 4, 2023

Janssen announced its positive long-term safety and clinical data for Stelara® (ustekinumab) in Chron’s disease and ulcerative colitis (five and four years respectively) at the ECCO CongressThe findings indicate that key safety events were similar between a placebo and Stelara®The data demonstrated that of the patients with moderate to severe ulcerative colitis who achieved clinical response and continued treatment with Stelara® for 200 weeks – 58% were in clinical remission and 80% were in clinical response.  

March 2, 2023

On Thursday, US District Court Judge Noreika denied a motion filed by Janssen Biotech, Inc (a Johnson & Johnson subsdiary) for a preliminary injunction regarding Amgen’s ustekinemab biosimilar, because the motion did not comply with the court’s page limit requirements.  We previously reported that Janssen commenced proceedings against Amgen in the US District Court (District of Delaware) in November 2022, asserting infringement of two patents, US 6902734 (ustekinemab compound) and US 10961307 (use of ustekinemab for the treatment of ulcerative colitis).   Judge Noreika ordered that the motion may be refiled in compliance with court requirements, so the consequences of the denial may be short-lived.   Janssen’s original Complaint states that Amgen had notified Janssen of its intention to commence marketing its Stelara® biosimilar on 6 May 2023 or as soon as it received FDA approval thereafter.

March 1, 2023

Alvotech announced its full financial results for 2022, highlighting its annual revenue increased by 114% to USD$85M, primarily driven by the commercialisation of AVT02 (adalimumab), biosimilar to AbbVie’s Humira® in 17 countries.  As of December 31, 2022, the company had cash and cash equivalents of US$66.4 million, and R&D expenses were US$180.6 million.  In addition, Alvotech highlighted recent corporate achievements, including its marketing applications for AVT04  (ustekinumab), a proposed biosimilar to Johnson & Johnson’s Stelara® in the US (FDA accepted BLA for review in January 2023 with a new goal date of 13 April 2023), and EU (expected EMA recommendation in the second half of 2023).

The company held a business update conference with the investment community on 2 March 2022.

Robert Wessman, Chairman and CEO of Alvotech said that “Looking ahead, 2023 is expected to be equally important.  We’re currently preparing for a reinspection of our Reykjavik facility by the FDA, which, if satisfactory, could pave the way for the approval and subsequent launch of our interchangeable, high concentration biosimilar to Humira® in the US market on July 1, 2023.”

February 14, 2023

JSR Life Sciences’ Similis Bio announced plans to enter into a partnership with Novel351K to co-develop three undisclosed biosimilar programs.  Under the initial agreement, Similis will be responsible for cell line development, analytics, process development, and cGMP production, leading to pharmacokinetics/pharmacodynamic clinical trials, while Novel351K will assist with accelerating the development of the programs to commercialisation.

February 9, 2023

Alvotech and STADA announced that EMA has accepted the MAA for Alvotech’s AVT04 biosimilar to Janssen’s Stelara™.  The companies expect the EMA to recommend AVT04 for approval as early as the second half of 2023.  In January 2023, the FDA accepted for review the BLA for AVT04.

February 2, 2023

Fresenius Kabi and Formycon AG announced they have reached a global license agreement to commercialise FYB202, biosimilar to Johnson & Johnson’s Stelara®. Under the agreement, Fresenius will have the exclusive commercialisation rights in key global markets, whilst Formycon will be responsible for development and registration with health authorities.

On 19 September 2022, Formycon announced that it was developing a biosimilar to Merck’s Keytruda® (pembrolizumab).

January 16, 2023

Korea Biomedical Review reported that Dong-A STl has published the results of its global Ph III trials of DMB-3115 (biosimilar ustekinumab).  Dong-A ST reported that the study confirmed the therapeutic equivalence and safety of DMB-3115 compared to Janssen’s Stelara®.  DMB-3115 will be commercialised by Intas Pharma in Japan, Korea and certain countries in Asia under a July 2021 agreement.

January 9, 2023

Rani Therapeutics announced that it has partnered with Celltrion for the development of RT-111 (orally administered ustekinumab biosimilar).  Under the agreement, Celltrion will exclusively supply drug substance CT-P43 (biosimilar ustekinumab drug substance) to Rani.  Rani is granted an exclusive licence to use CT-P43 in the development and commercialisation of RT-111 and Celltrion has a right of first negotiation to acquire worldwide rights to RT-111 following Ph I trials.  The RaniPill™ capsule, is “intended to replace subcutaneous or intravenous injection of biologics and drugs with oral dosing”.

January 6, 2023

Alvotech and Teva announced that the FDA has accepted for review a BLA for AVT04 (biosimilar ustekinumab). Alvotech reported that it expects the review to be completed in the second half of 2023.  AVT04 is being developed under a strategic agreement between Alvotech and Teva announced in August 2020.

2022

December 12, 2022

The EMA reported that it is reviewing an application for biosimilar ustekinumab.  If approved, this will be the first ustekinumab biosimilar approved in the EU.

November 30, 2022

Janssen sued Amgen in the District Court of Delaware in relation to Amgen’s ABP654 (biosimilar ustekinumab).  Janssen alleges that Amgen’s product will infringe US patent Nos 6,902,734 (API) and 10,961,307 (methods of treating ulcerative colitis).  Amgen released preliminary results from its Ph III trials of ABP654 in April 2022, and it has not yet been approved by the FDA.

November 29, 2022

Hikma Pharmaceuticals announced that it has signed an exclusive licence agreement with Celltrion for CT-P43 (biosimilar ustekinumab).  Under the agreement, Hikma will receive exclusive rights to market Celltrion’s product in all of Hikma’s MENA markets.

November 17, 2022

Korea Biomedical Review reported that Dong-A ST has completed Ph III trials of DMB-3115 (biosimilar ustekinumab).  Dong-A ST reported that it plans to file for regulatory approval in the US and Europe in the first half of 2023.  DMB-3115 has been jointly developed by Dong-A ST and Meiji Seika Pharma.  Intas Pharma and Meiji/Dong-A ST signed a commercialisation agreement in July 2021 for DMB-3115.

October 28, 2022

The Australian Pharmaceutical Benefits Advisory Counsel (PBAC) published the public summary documents from its July 2022 meeting.  Among the updates were:

  • Yuflyma® (adalimumab): recommended with ‘a-flagged’ status for the same indications as Humira®.
  • Tysabri® (natalizumab): amended listings (removing a requirement for neurologists prescribing natalizumab to be registered with the Tysabri Australian Prescribing Program) recommended by PBAC.
  • Epidyolex® (cannabidiol): not recommended for the treatment of Lennox-Gastaut syndrome, as the incremental cost effectiveness ratio was deemed to be unacceptably high at the price proposed.
  • Keytruda® (pembrolizumab): amended listings (increasing the max number of repeats, and maximum number of cycles in a lifetime) recommended by PBAC.
  • Stelara® (ustekinumab): vial for IV infusion and PFS recommended for the treatment of moderate to severe ulcerative colitis. 90mg/1mL PFS recommended for the treatment of Crohn disease and severe chronic plaque psoriasis.

October 24, 2022

Rani Therapeutics announced that it has commenced preclinical development of RT-111 a RaniPill GO capsule containing an ustekinumab biosimilar.  BioFactura and Rani Therapeutics entered into an agreement in September 2021 to assess Bio-Thera’s BFI-751 (ustekinumab biosimilar) in combination with Rani’s RaniPill® platform.

October 17, 2022

Biocon Biologics announced that it will license its ustekinumab and denosumab biosimilars to Yoshindo for Japan.  Yoshindo will pay an upfront licence fee and further payments over the next few years as certain development milestones are achieved. Biocon Biologics estimates the market opportunity for the two biosimilars in Japan to be US$700m.

October 14, 2022

BioFactura has announced successful completion of its Ph I trials relating to biosimilar ustekinumab candidate BFI-751.  The trial in Australia and New Zealand involved 226 subjects and demonstrated bioequivalence of BFI-751 to the US and EU versions of Janssen’s Stelara.  BioFactura now intends to conduct a Ph III confirmatory safety and efficacy trial in patients.

September 7, 2022

Yonhap News Agency reported that Celltrion’s ustekinumab biosimilar CT-P43 Ph III trials demonstrated comparable efficacy and safety to Janssen’s Stelara®.  Data from the global 28-week study in 509 plaque psoriasis patients was presented at the European Academy of Dermatology and Venereology Congress 2022 in Milan, Italy.

September 6, 2022

German based biosimilars focussed company Formycon published its preliminary and unaudited financial results for the first half of 2022.  Formycon reported a turnover of Euro 17.6 million in the first six months of 2022.  The preliminary report does not include the purchase price allocation effects from the ATHOS transaction reported in May 2022 under which Formycon acquired rights to FYB202 (biosimilar Stelara®), 50% of the rights to FYB201 biosimilar Lucentis® and the operational development unit Bioeq GmbH.  Formycon has six biosimilars in development, and is also working on the development of a COVID-19 drug FYB207.

August 31, 2022

Alvotech published its first half 2022 financial results, reporting a revenue growth to over $40 million compared to $2.0 million in the first half of 2021 due to recent launches of adalimumab (AV02) in Canada and Europe.  The company has $128.4Min cash/equivalents and has current borrowings of $120.8M.  Its R&D costs in the same period were 86.9M.

Alvotech “pipeline highlights” includes (amongst other things) an exclusive global licence agreement with BiosanaPharma regarding biosimilar omalizumab/to Xolair®, expanded partnership with Fuji Pharma, the completion and US submission of interchangeability studies for its high concentration adalimumab biosimilar, a US settlement with AbbVie relating to adalimumab and positive results from clinical studies on AVT04 (biosimilar ustekinumab/Stelara®).  Alvotech also secured funding of approximately $185M through the OACB merger and PIPE financing.

August 16, 2022

Formycon has reported that its ustekinumab biosimilar candidate FYB202 showed comparable efficacy and safety to Janssen’s Stelara in a Ph III clinical trial in plaque psoriasis patients.  Formycon’s extended pharmacokinetics Ph I study has commenced.  This follows Formycon’s acquisition of 100% of the rights to FYB202 from Athos, as previously reported.

August 1, 2022

Janssen announced that the FDA has approved Stelara® (ustekinumab) for the treatment of paediatric patients aged six and over with active psoriatic arthritis (PsA).  As there were insufficient paediatric patients with PsA to conduct clinical trials, the FDA based its approval on phase III trials in adults and children with plaque psoriasis and adults with PsA.

July 6, 2022

Janssen’s Stelara® (ustekinumab): requesting a General Schedule Authority Required listing of a new form for the treatment of patients with Crohn disease and chronic plaque psoriasis

June 21, 2022

Formycon published its Q1 2022 financial results, reporting sales and other earnings of EUR 8.2 million.  Formycon also announced the addition of two biosimilar projects to its pipeline, FYB208 and FYB209, for undisclosed products.  Late stage Formycon development programs include biosimilars to Lucentis® (ranibizumab), Stelara® (ustekinumab) and Eylea® (aflibercept). Formycon plans to launch its biosimilar to Lucentis® (ranibizumab) in the second half of 2022.

May 16, 2022

Alvotech announced positive top-line results from a 3 arm, parallel design study conducted in Australia and New Zealand regarding AVT04 (ustekinumab biosimilar), reporting that the study results demonstrate bioequivalence between AVT04 and Janssen’s Stelara®.  Teva and Stada are Alvotech’s exclusive strategic partners for commercialising AVT04 in the US and EU respectively.

May 10, 2022

Merck announced that it will present data from studies of six medicines and pipeline candidates in more than 25 cancers at the 2022 American Society of Clinical Oncology Annual Meeting in June.  This will include data on Keytruda® (ustekinumab), Lenvima® (lenvatinib) and its investigational anti-LAG-3 therapy favezelimab.

May 10, 2022

Formycon and Athos KG announced closing of the acquisition by Formycon of 50% of the rights to FYB201 (biosimilar ranibizumab), 100% of the rights to FYB202 (biosimilar ustekinumab), together with Bioeq GMBH, which is described as its “long-time partner”.  The total value of the deal is €650M.

April 18, 2022

Amgen released preliminary results from its Ph III study of ABP654 (proposed ustekinumab biosimilar) in adults with severe plaque psoriasis.  Amgen reported that the study met the primary efficacy endpoint, and that the safety profile of ABP654 was comparable to STELARA®.

March 29, 2022

Formycon and Athos KG announced that they have agreed to enter into a long-term strategic partnership regarding biosimilars.  As part of this agreement, Formycon will acquire 100% of the rights in FYB202 (biosimilar ustekinumab candidate) and a 50% stake in FYB201 (biosimilar ranibizumab candidate) in exchange for EUR 650 million.

January 26, 2022

Vizient announced that remdesivir has replaced Humira® (adalimumab) as the most expensive drug by total member spend in its Winter 2022 Market Outlook.  Pembrolizumab, ustekinumab, ocrelizumab, denosumab, infliximab, nivolumab and tocilizumab also featured in the top 10 most expensive drugs by member spend.

2021

December 14, 2021

Hyphens Pharma announced that it has signed an exclusive license and supply agreement with DKSH’s subsidiary Favorex Pte Ltd for the commercialisation of Alvotech’s proposed biosimilar ustekinumab in Singapore, Malaysia and the Philippines.

December 7, 2021

Alvotech and Oaktree Acquisition Corp. II announced that they have entered into a merger agreement for the creation of a publicly-traded global biopharmaceutical company. Alvotech is led by a team of highly experienced biopharma leaders, including Mark Levick as CEO, Anil Okay as CCO, and Philip Caramanica as Chief IP Counsel and Deputy General Counsel. The merger is expected to deliver gross proceeds to Alvotech in excess of USD$450 million.  Alvotech currently has seven products in its pipeline, including a biosimilar candidate to Humira® (adalimumab), Stelara® (ustekinumab), Eylea® (aflibercept), Prolia®/Xgeva® (denosumab) and Simponi®/Simponi ARIA® (golimumab).

November 10, 2021

Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.

October 25, 2021

Janssen announced data from two new analyses of Stelara® (ustekinumab) for the treatment of adults with Crohn’s disease and ulcerative colitis. Janssen reported that the data from these analyses provides additional support for Stelara® as a first-line option for Crohn’s disease and ulcerative colitis.

October 16, 2021

Bio-Thera Solutions announced it has reached a licensing and supply agreement with Pharmapark for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Pharmapark will have exclusive rights to distribute and market the product in Russia and other CIS countries.

October 8, 2021

Janssen announced the submission of a sBLA to the FDA seeking expanded approval of Stelara® (ustekinumab) to treat paediatric patients aged 5 years and older with juvenile psoriatic arthritis.

September 9, 2021

BioFactura announced it has reached an agreement with Rani Therapeutics to assess BFI-751 (proposed ustekinumab biosimilar) in combination with the RaniPill® platform. The RaniPill® capsule is intended to replace subcutaneous or IV injection of biologics with oral dosing.

August 27, 2021

Bio-Thera Solutions and Hikma Pharmaceuticals announced that they have signed an exclusive commercialisation and license agreement for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Hikma will gain exclusive commercialisation rights in the US with a first-right-to-negotiate to add Europe (excluding CIS countries) to the agreement.

July 22, 2021

Intas Pharma announced it has signed a commercialisation agreement with Meiji and Dong-A St for DMB-3115 (proposed ustekinumab biosimilar). Under the agreement, Intas will receive exclusive licensing rights to DMB-3115 worldwide excluding Japan, Korea and certain countries in Asia.

July 19, 2021

Samsung Bioepis announced that it has commenced Ph III trials of SB17 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

July 15, 2021

Bio-Thera Solutions announced that the first patient has been dosed in its Ph III trials of BAT206 (proposed ustekinumab biosimilar).

July 6, 2021

Australia’s PBAC recommended the listing of Amgen’s Mvasi® (biosimilar bevacizumab). The PBAC also recommended listing Keytruda® (pembrolizumab) for the first line treatment of unresectable or metastatic mismatch repair deficient colorectal cancer and recommended listing Stelara® (ustekinumab) for the treatment of paediatric patients with severe chronic plaque psoriasis.

July 6, 2021

Alvotech announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study for AVT04 (proposed ustekinumab biosimilar). The trial is being conducted in Central and Eastern Europe and approximately 530 patients are expected to be enrolled in the study.

May 25, 2021

BioFactura announced the initiation of Ph I trials of BFI-751 (proposed ustekinumab biosimilar). The trial is being conducted across three sites in Australia and New Zealand.

 

May 20, 2021

Meiji Seika Pharma announced its Ph I trials of DMB-3115 (proposed ustekinumab) biosimilar demonstrated the bioequivalence of its product to the reference product.

May 12, 2021

Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%.  Celltrion announced that it is planning to complete Ph III trials of biosimilar bevacizumab in the first half of 2021, and that ustekinumab, aflibercept, omalizumab and denosumab candidates remain in Ph III trials.

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).

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

December 21, 2020

Celltrion announces Ph III trials of its proposed ustekinumab biosimilar CT-P43 will be completed by the second half of 2022. Celltrion also announced plans to launch the product when the API patents expire in the EU in September 2023 and in the US in July 2024.

November 9, 2020

Formycon and Bioeq announce they have commenced dosing in Ph III trials of FYB202 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

October 28, 2020

In its Q3 2020 financial results, Amgen announces that it is moving ABP 654 (proposed ustekinumab biosimilar) into Ph III development.

October 20, 2020

Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commence recruiting in Poland.

October 20, 2020

NeuClone announces its proposed ustekinumab biosimilar has successfully met all primary and secondary endpoints in Ph I clinical trials. Noelle Sundstrom, CEO of NeuClone announced that the company plans to enter Ph III trials in 2021. The product is being jointly developed by NeuClone and the Serum Institute of India.

October 16, 2020

Polpharma publishes ustekinumab biosimilar is under development.

September 10, 2020

A new study presented at the Congress of Clinical Rheumatology East indicates that ustekinumab is safe and efficacious in young and elderly patients with psoriatic arthritis. Researchers reported that there were no clinically meaningful differences in the effectiveness and safety in PsA patients 60 years or older compared with those younger than 60.

September 3, 2020

Bio-Thera Solutions commences dosing in Ph I clinical trials of BAT2206 (proposed ustekinumab biosimilar).

July 30, 2020

Janssen announces the FDA approved an additional indication for Stelara® (ustekinumab) for paediatric patients with skin lesions or moderate to severe plaque psoriasis.

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.

June 26, 2020

Janssen announces it has discontinued its Ph III LOTUS study of Stelara® (ustekinumab) in Systematic Lupus Erythematosus due to lack of efficacy.

May 15, 2020

Formycon releases an update on its biosimilar portfolio. Ph III clinical trials for a proposed ustekinumab biosimilar are scheduled to commence in Q3 2020.

April 8, 2020

NeuClone Pharma announces it has completed monitoring visits and blood sampling for Ph I trials of NeuLara.

March 26, 2020

Janssen announces approval of additional indication of ulcerative colitis for Stelara® (ustekinumab) in Japan.

March 14, 2020

J&J announces Dano® is now also indicated for the treatment of adults with moderate to severe Crohn’s Disease. 

January 27, 2020

Health Canada approves ulcerative colitis as an additional indication for Stelara®.

January 22, 2020

The UK’s NICE announces it will not recommend Stelara® for moderately to severely active ulcerative colitis due to uncertainties over cost-effectiveness.

2019

December 18, 2019

NeuClone announces completion of patient recruitment and dosing in Ph I trials of ustekinumab biosimilar.

December 16, 2019

Dong-A Socio Holdings and Meiji Seika announce commencement of Ph I trials of ustekinumab biosimilar.

December 4, 2019

Bio-Thera announces NMPA approval to commence Ph I trials of ustekinumab biosimilar.

October 28, 2019

Formycon announces dosing has begun in PhI clinical trials of ustekinumab biosimilar.

October 17, 2019

NeuClone announces it has commenced dosing in Phase I clinical trials of biosimilar ustekinumab candidate. 

September 9, 2019

Janssen announces EC approval for additional indication for Stelara®. Stelara® is now indicated for the treatment of ulcerative colitis.

 

August 16, 2019

JHL Biotech publishes ustekinumab biosimilar is under development.

May 15, 2019

NeuClone confirms Ph1 trials of biosimilar ustekinumab will commence in the second half of 2019, as previously announced.

April 9, 2019

Alvotech and Fuji Pharma announce exclusive agreement for the commercialisation of Stelara® biosimilar in Japan. Alvotech will be responsible for development and supply while Fuji Pharma will receive exclusive rights to commercialise the drug in Japan. This follows Fuji Pharma’s recent US $50 million investment in Alvotech.

 

 

2018

May 10, 2018

Australia’s NeuClone announces preclinical results for its biosimilar ustekinumab, which are now scheduled for Ph 1 clinical trials in 2019.

 

January 8, 2018

Australia’s NeuClone confirms ongoing development of biosimilar ustekinumab, which is on target to enter Ph I trials in 2018.  Read more

2017

May 11, 2017

Germany’s Formycon is developing biosimilar ustekinumab, targeting 2023 for a US launch, and 2024 for EU launch.  Read more

BioBlast® extract From May 11, 2017 to March 9, 2024