Insights+ Key Biosimilars Events of October 2023

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Insights+ Key Biosimilars Events of October 2023

  • Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency 
  • Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients 

  • During the month of October, Boehringer launched adalimumab injection (biosimilar, Humira) for multiple chronic inflammatory diseases and Alvotech and Kashiv signed an agreement for the development and commercialization AVT23. Our team at PharmaShots has summarized 9 key events of the biosimilar space of October 2023 

1. Boehringer Ingelheim Reports the Commercial Availability of Humira Biosimilar 

Date: Oct 2, 2023  

Product: Adalimumab Injection (biosimilar, Humira) 

  • The company launch adalimumab inj., an interchangeable biosimilar to Humira (adalimumab) at a low wholesale acquisition cost for the treatment of multiple chronic inflammatory diseases & is set to be priced at an 81% discount to Humira 

  • The product was also approved to treat moderately to severely active Crohn's disease in children aged ≥6yrs. as well as moderately to severely active polyarticular juvenile idiopathic arthritis in children aged 2yrs. 

  • Adalimumab inj. is a citrate-free formulation and is supplied as 40mg/0.8mL, 20mg/0.4mL, and 10mg/0.2mL prefilled syringes and as a 40mg/0.8mL prefilled autoinjector. The biosimilar is also available under the brand name Cyltezo 


2. Kashiv BioSciences Reports the First Patient Enrolment of ADL018 (biosimilar, omalizumab) in the P-III Clinical Study for Chronic Spontaneous Urticaria 

Date: Oct 3, 2023  

Product: ADL018 

  • The first patient has been enrolled in the P-III study of ADL018 vs Xolair in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic on H1 antihistamine treatment. Additionally, ~600 patients are expected to enroll globally in sites across the US, EU & India 

  • The trial focuses on comparing ADL018 & Xolair in terms of efficacy, safety, tolerability & immunogenicity. ADL018, a humanized mAb that inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells and basophils & is being developed as a biosimilar candidate to Xolair (omalizumab) 

  • Omalizumab was approved for persistent asthma in patients aged ≥6yrs. & chronic rhinosinusitis with nasal polyps in patients aged ≥18yrs. 


3. Alvotech Entered into an Exclusive License Agreement with Kashiv BioSciences to Develop and Commercialize AVT23, a Proposed Biosimilar to Xolair (omalizumab) 

Date: Oct 4, 2023  

Product: AVT23 

  • Kashiv will receive an upfront and is eligible to receive subsequent milestones and royalties, following the successful development and approval of AVT23 which is currently in clinical development 

  • Alvotech will get an exclusive license to commercialize AVT23 (developed and manufactured by Kashiv). The agreement was valid in all 27 countries of the EU, the UK, Australia, Canada, and New Zealand 

  • Omalizumab, a humanized mAb targeting free IgE. Xolair which contains omalizumab & is indicated for diseases i.e., sev. persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria. The therapy was developed by Novartis and licensed by Roche 


4. Pfizer Receives Interchangeable Designation of Abrilada, a Biosimilar to Humira from the US FDA 

Date: Oct 5, 2023  

Product: Abrilada 

  • Abrilada (adalimumab-afzb), a biosimilar to Humira (adalimumab) had received an interchangeable designation from the US FDA. The designation applies to all its approved indications, incl. RA, JIA, PsA, AS, CD, UC, PsO, hidradenitis suppurativa and uveitis 

  • The designation was based on the P-III study (REFLECTIONS B538-12) results published in The Lancet Rheumatology demonstrated similar patient outcomes in terms of PK, safety, and immunogenicity in patients with active RA who switched multiple times b/w Abrilada and Humira 

  • ABRILADA will be available at a list price 5% lower than that of Humira with a second list price 60% lower than that of Humira anticipated later in 2023 


5. Bio-Thera Solutions Receives the US FDA’s Approval for Tofidence (biosimilar, tocilizumab) 

Date: Oct 9, 2023 

Product: Tofidence (biosimilar, tocilizumab) 

  • The US FDA has approved Tofidence (IV), the first biosimilar to reference Actemra for moderately to severely active RA, polyarticular JIA & systemic JIA. Tofidence was developed & manufactured by Bio-Thera Solution and will be marketed by Biogen 

  • The approval was based on data demonstrating that Tofidence is highly similar to the reference product with no clinically meaningful differences. The P-I study evaluating the PK, safety & immunogenicity of Tofidence vs tocilizumab in healthy participants as well as the P-III study 

  • The P-III study results showed similar efficacy b/w Tofidence & tocilizumab groups. At 12wk., 69% vs 65% achieved an ACR20 percent response while 69% vs 68% at 24wk., comparable PK, safety & immunogenicity profiles were also reported 


6. Samsung Bioepis Presents Post-hoc Analysis of P-III Clinical Trial for SB15, a Proposed Biosimilar to Eylea (Aflibercept) at EURETINA 2023 

Date: Oct 9, 2023  

Product: SB15 (biosimilar, Eylea) 

  • The company highlighted the post-hoc analysis from the P-III clinical study evaluating 3 monthly injections (2mg) of SB15 vs aflibercept followed by treatment q8w for ~48wk. in a ratio (1:1) in 449 study patients 

  • The results showed that switching to SB15 from aflibercept maintained comparable clinical efficacy and safety in treating nAMD patients & confirmed biosimilarity between these agents before and after switching 

  • Samsung Bioepis and Biogen signed an exclusive commercialization agreement in Nov 2019 for two ophthalmology biosimilar candidates, SB11/Byooviz (ranibizumab) and SB15 (aflibercept) in major markets globally 


7. Alvotech Receives Complete Response Letter from the US FDA on the BLA for AVT04 (biosimilar, ustekinumab) 

Date: Oct 12, 2023  

Product: AVT04 (biosimilar, ustekinumab) 

  • The US FDA has issued a complete response letter to Alvotech’s application for AVT04, a biosimilar candidate to Stelara citing certain deficiencies at Alvotech’s manufacturing facility in Reykjavik, Iceland during a site inspection in Mar 2023 

  • No other deficiencies were noted by the US FDA which stated that once these are resolved, it will approve the application. The company plans to resubmit the application for AVT04 to the FDA shortly which could trigger a 6mos. review period 

  • Alvotech and Teva reached a settlement and license agreement with J&J for AVT04 in the US in June 2023. AVT04 is expected to be available in the US in Feb 2025 


8. Amneal Expands its Partnership with mAbxience for Denosumab Biosimilars and Expanding Oncology Portfolio 

Date: Oct 12, 2023 

Product: Denosumab Biosimilars 

  • The companies collaborated for the development and commercialization of two denosumab biosimilars. Additionally, Amneal adds Prolia and Xgeva biosimilars to its oncology portfolio 

  • mAbxience will be responsible for developing and manufacturing the two biosimilars while Amneal will oversee the candidates through US regulatory approval pathways & also get an exclusive commercialization right in the US 

  • Denosumab is a mAb that inhibits bone reabsorption & is indicated for bone metastasis from various forms of cancer and prevention of bone pain and fractures, incl. osteoporosis-related injuries 


9. Amgen Receives the US FDA’s Approval of Wezlana (Biosimilar, ustekinumab) for the Treatment of Multiple Inflammatory Diseases 

Date: Oct 31, 2023 

Product: Wezlana (ustekinumab-auub) 

  • The approval was granted based on scientific evidence showing high similarity to Stelara with no clinically meaningful differences in safety and effectiveness and met the criteria to be interchangeable with Stelara    

  • Wezlana has been approved for the adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis 

  • It has also been approved for pediatric patients aged 6 yrs. to treat moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis 


Related Post: Insights+ Key Biosimilars Events of September 2023 

Kritika Jha

Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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