Pearce IP BioBlast w/e 8 March 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.   

Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events (MACE) including death, myocardial infarction, or stroke in adults with obesity and/or established cardiovascular disease (CVD). The approval is based on results of the SELECT trial, which demonstrated that Wegovy® reduced MACE by 20%. It is the first US approved therapy to assist with weight management and reduce cardiovascular risk.

Novo Nordisk has also requested equivalent label expansion in EU with the decision expected in 2024.

The approval comes soon after Novo Nordisk announced results of its FLOW study for Ozempic® (semaglutide) for kidney outcomes..

This news follows the announcement on 5 February 2024 by Novo Holdings (Novo Nordisk’s parent company) that it will acquire global contract development and manufacturing company Catalent for USD $16.5B.

Regeneron announced one-year results from studies show that extended dosing regimens (12 or 16 weeks) for Regeneron’s and Bayer’s Eylea® HD (aflibercept) 8mg injection demonstrated non-inferiority to Eylea® 2mg injection (with 8-week dosing) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).  The findings are based on the Regeneron and Bayer sponsored Phase III PULSAR (nAMD) and Phase II/III PHOTON (DME) trials. 

High Dose Eylea® is approved in multiple countries including the US (August 2023 – nAMD, DME and diabetic retinopathy, the EU (January 2024 – nAMD and DME and Japan (January 2024 – nAMD and DME. 

On 6 March 2024, Johnson & Johnson (J&J) announced that it has submitted an application to the European Medical Agency (EMA) for DARZALEX® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma.  The application is supported by data from the Phase 3 PERSEUS study, which shows that when daratumumab is administered in a subcutaneous formulation it significantly reduces the risk of myeloma progression or death when compared to standard of care regimen. 

This follows J&J’s announcement on 30 January 2024 that it submitted a sBLA to FDA for the Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Combination 

On 6 March 2024, the FDA announced its approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for treatment of adults with unresectable or metastatic urothelial carcinoma.   

Previously in February 2024 and in December 2023, BMS announced that the FDA accepted its sBLA for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) and also accepted for priority review its sBLA for Opdivo® in combination with cisplatin-based chemotherapy for the treatment of unresectable or metastatic urothelial carcinoma. 

Johnson and Johnson (J&J) and Janssen have filed a Motion to Dismiss [Link to emailed document] 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.   

On 5 March 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Genentech’s/Roche’s Actemra®, for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  Tyenne® is the second FDA-approved tocilizumab biosimilar, following the approval of Biogen’s IV formulation Tofidence® in September 2023, but is the first approved subcutaneous formulation.  Tyenne® was approved by the FDA in both IV and subcutaneous forms. The US launch date for its tocilizumab products remains confidential following a patent settlement with Roche and Chugai in October 2022.   

Tyenne® has launched in more than 10 countries to date, including in Europe in November 2023 in both IV and subcutaneous formulations.  Fresenius reports that its global roll out will continue through 2024 and 2025. 

On 5 March 2024, the FDA approved the first denosumab biosimilars in the US in Sandoz’s Wyost® and Jubbonti®.  The biosimilars are interchangeable with, and approved for all indications of, Amgen’s Xgeva® and Prolia® respectively. 

The US launch date for the newly approved biosimilars is uncertain given ongoing BPCI litigation regarding the products, commenced by Amgen in May 2023 relating to 21 patents. 

The US approval comes weeks after Sandoz announced the approval of Jubbonti® in Canada.  Prolia® biosimilars developed by Boan Biotech and Mabwell were approved in China respectively in November 2022 (BA6101, Byoubei®) and March 2023 (Mailishu®). 

Novo Nordisk announced the results of its Ozempic® (Semaglutide 1.0) FLOW study kidney outcomes.  In this study, semaglutide 1.0 mg was compared to placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in more than 3,500 people with type 2 diabetes and chronic kidney disease (CKD).  The trial demonstrated a 24% reduction in kidney disease progression, major adverse cardiovascular events (MACE) and death in people treated with semaglutide 1.0 mg compared to placebo.  Novo Nordisk intends to file for regulatory approval for label expansion around the world in 2024. 

This comes as the company is addressing counterfeit products around the world as reported on 1 March 2024 and 5 February 2024.  

On 5 March 2024, the Times of India reported that Roche launched Vabysmo® (faricimab) in India for the treatment of age-related macular degeneration (nAMD) and diabetic macular edema (DME).    

Vabysmo® was first approved in the US by the FDA in January 2022 and is now available in multiple countries, including Europe, Canada and Australia.  In October 2023, Roche received a new indication approval by FDA for the use of Vabysmo® to treat macular oedema following retinal vein occlusion.  Since its first launch date, Vabysmo ® has achieved global sales of US$2.7 billion.   

A paper published in Nature Communications on 5 March 2024 regarding a Phase II clinical trial sponsored by Arcagy-GINECO showed that FKB238 (bevacizumab biosimilar) + olaparib + durvalumab combination showed better survival for treatment of patients with relapsed ovarian cancer than patients with no treatment.  Between 1 March 2019 and 23 January 20202, a total of 74 patients were enrolled in nine French centres and were treated with the bevacizumab biosimilar FKB238 (15 mg/kg intravenously, once-every-3-weeks), olaparib (300 mg orally, twice daily), and durvalumab (1.12 g intravenously, once-every-3-weeks).  

On 4 March 2024, Sandoz announced the completion of its acquisition of biosimilar CIMERLI® (ranibizumab) from Coherus BioSciences. This VEGF inhibitor ranibizumab was approved by the FDA on 2 August 2022 and is indicated for the treatment of retinal diseases. The acquisition includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software. Sandoz announced its USD $170M deal to acquire CIMERLI® on 22 January 2024, and now reports that the deal was completed ahead of schedule.  

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. 

Biocon announced a settlement with Regeneron and Bayer under which it can launch its Yesafili® (aflibercept), biosimilar to Regeneron’s Eylea®, in Canada from 1 July 2025.  The settlement resolves multiple patent infringement proceedings in the Federal Court of Canda involving six patents relating to aflibercept.  The settlement does not appear to have resolved disputes beyond Canada, there being no impact to the ongoing US aflibercept dispute between Biocon and Regeneron.   

Yesafili® was granted tentative approval by Health Canada in March 2023, subject to resolution of patent issues.  Yesafili® was approved in the UK in November 2023 and in EU in September 2023.