Insights+ Key Biosimilars Events of December 2023

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Insights+ Key Biosimilars Events of December 2023


  • Stay up to date with PharmaShots Biosimilars Report, a monthly digest designed to keep you familiarized with the recent developments in biologics 
  • Biosimilars are cost-effective alternatives to branded drugs but are very much alike when it comes to safety and efficacy 
  • Check out the developments in the Biosimilars with PharmaShots’ illuminating report. PharmaShots has compiled 13 key events in the biosimilars space 


Samsung Bioepis Successfully Resolves Patent Disputes with Johnson & Johnson 

Date: Dec 1, 2023 

Product: SB17 (biosimilar ustekinumab) 

  • Samsung Bioepis has successfully resolved all patent litigation with Johnson & Johnson through a settlement & license agreement. This significant development clears the legal obstacles for the US commercialization of SB17 (biosimilar ustekinumab) 
  • The license period is set to commence on Feb 22, 2025, with specific terms remaining confidential. SB17 serves as an alternative for plaque psoriasis, CD, UC, & active PsA – indications for which Stelara is approved 
  • The BLA for SB17 is currently under review by the US FDA. Upon approval, SB17 will be commercialized in the US by Sandoz, as outlined in the development & commercialization agreement between Samsung Bioepis & Sandoz, signed in Sep 2023. This collaboration extends to the markets of the US, Canada, EEA, Switzerland, and UK 


Enzene Biosciences Reports the Launch of Ranibizumab Biosimilar for the Treatment of Neovascular Age-Related Macular Degeneration (AMD)

Date: Dec 03, 2023 

Product: Accentrix (biosimilar, Ranibizumab) 

  • Enzene Biosciences launches Accentrix (biosimilar Lucentis), across India for the treatment of patients with neovascular AMD  
  • Accentrix has depicted a comparative clinical efficacy to Lucentis in a P-III trial. The biosimilar demonstrated comparable product purity and binding and inhibition of VEGF-A, effectively interrupting its interaction with its receptors 
  • Enzene developed Accentrix using its “state of the art MAR system” in Chakan plant (Pune, India). Additionally, Enzene is currently developing three biosimilars in across stages with plans to expand footprint in the US 


Bio-Thera Reports the Results for BAT2206 in P-III Trial for the Treatment of Plaque Psoriasis 

Date: Dec 06, 2023 

Product: BAT2206 (biosimilar, Ustekinumab) 

  • The P-III clinical trial evaluated the efficacy, safety, immunogenicity & PK of BAT2206 vs Stelara in patients (n=556) with moderate too severe plaque psoriasis 
  • The results from the study depicted that the 1EP of improvement in PASI score to wk12 with BAT2206 showed similar effects to originator. Results will be soon announced in medical conference 
  • BAT2206 is a biosimilar version of Stelara (ustekinumab) and is the Bio-Thera's 4th biosimilar to achieve positive P-III results. In Aug 2021, Bio-Thera entered into a commercialization and license agreement with Hikma for BAT2206 


Amgen Report Results for ABP 959 in Clinical Trial for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) 

Date: Dec 06, 2023 

Product: ABP 959 (biosimilar, eculizumab) 

  • The company presented the results from the parallel & crossover comparisons along with the PK analysis of ABP 959 vs Soliris in patients with PNH. The results were presented by the company at the ASH 2023  
  • The results from both the parallel & crossover comparisons depicted similar efficacy data as determined by hemolysis in patients along with a similar PK between the 2 treatments seen through the analyses of serum total & unbound PK concentrations  
  • ABP 959 has already been approved in the EU with brand name Bekemv whereas its originator Soliris is approved in many indications incl. PNH, aHUS, gMG & NSOD. Post settlement with Alexion biosimilar can’t be launched in US till Mar 1, 2025 


Formycon’s Ranopto Receives Health Canada’s Approval for the Treatment of Several Retinal Diseases  

Date: Dec 07, 2023 

Product: Ranopto (FYB201, biosimilar, ranibizumab) 

  • Formycon along with its partners Polpharma Biologics Group BV, Bioeq AG & Teva Canada have received Health Canada’s Notice of Compliance (NOC) for Ranopto (FYB201, biosimilar Lucentis) for the treatment of various retinal diseases in Canada  
  • Ranopto was developed by Bioeq (JV of Formycon & Polpharma Biologics). In mid-2021, Teva entered a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe & other selected countries 
  • Teva expects to launch Ranopto in the Canada market by Q1’24. Ranibizumab functions by inhibiting the VEGF responsible for the excessive formation of blood vessels in the retina 


Bio-Thera Reports the US FDA’s Approval of Avzivi (Biosimilar, Avastin) 

Date: Dec 8, 2023 

Product: Avzivi (Biosimilar, Avastin) 

  • The FDA granted approval to Avzivi (BAT1706) based on a thorough analysis of analytical, non-clinical, & clinical data and the comparative studies b/w Avzivi and Avastin which confirmed biosimilarity by assessing structural, physicochemical, and biological properties 
  • The randomized, double-blind, three-arm parallel P-III trial investigated Avzivi vs Avastin for their efficacy, safety, and immunogenicity in treating advanced non-squamous NSCLC 
  • Bio-Thera will develop and manufacture Avzivi, while Sandoz has global (incl. US) commercialization rights as per a license and commercialization agreement initiated in Sep 2021 


LG Chem Receives the Korean MFDS’ Approval for Xelenka for the Treatment of Autoimmune Disease

Date: Dec 15, 2023 

Product: Xelenka (biosimilar, adalimumab) 

  • The company received marketing authorization from the Korean Ministry of Food and Drug Safety for Xelenka (biosimilar to Humira) for the treatment of autoimmune disorders 
  • LG Chem filed the marketing application with MFDS in Dec 2022. Moreover, this approved is granted for the high concentration of humira which is citrate free 
  • Xelenka like Humira is an Anti-TNF mAb indicated for RA, PA, Uveitis in adults, CD & JIA in children and this a second approval for LG Chem for autoimmune diseases after approval of biosimilar Eucept  


Medis Pharmaceuticals Reports Clinical Trial Results of Enoxa for the Prevention of Postoperative Subclinical Thrombosis 

Date: Dec 16, 2023 

Product: Enoxa (biosimilar, enoxaparin) 

  • The clinical trial evaluated the equivalence of Enoxa to Sanofi’s Lovenox in patients (n= 74 vs 71) with digestive cancers to prevent postoperative subclinical thrombosis across Tunisia  
  • The 1EP of the study was asymptomatic thromboembolic events assessed by Doppler ultrasound & 2EPs include thrombotic events, heparin-induced thrombocytopenia, bleeding events, and deaths  
  • As per the results, out of the evaluable patients, 4.1% vs 5.6% depicted a subclinical venous thrombosis whereas 6.9% vs 8.6% of patients showed combined clinical & subclinical events. Moreover, in terms of other 2EPs, there were no significant differences between the groups & death occurred in 12.6% vs 7.4% of patients  


Celltrion’s IND Application for CT-P55 was Approved by the PDMA to Initiate a P-I Clinical Trial for the Treatment of Psoriasis  

Date: Dec 18, 2023 

Product: CT-P55 (biosimilar, secukinumab) 

  • Following the IND approval, the company will initiate a P-I clinical trial evaluating CT-P55 in vs Cosentyx in patients (n=171) with psoriasis. The study will evaluate the PK equivalence between CT-P55 and Cosentyx (US & EU sourced) 
  • Moreover, the company expects to expand its autoimmune portfolio from tumor necrosis factor-alpha (TNF-alpha) inhibitors to interleukin inhibitors 
  • Cosentyx is an IL-17A inhibitor developed by Novartis for the treatment of psoriatic arthritis, ankylosing spondylitis & moderate-to-severe plaque psoriasis. Cosentyx’s patent expires in Jan 2029 in the US & in Jan 2030 in Europe 


Intas Pharmaceuticals Entered into a Collaboration and License Agreement with mAbxience for Etanercept Biosimilar to Treat Autoimmune Diseases 

Date: Dec 20, 2023 

Product: Etanercept Biosimilar 

  • Intas Pharmaceuticals signed a strategic exclusive licensing agreement with mAbxience for Etanercept biosimilar for the treatment of autoimmune diseases 
  • Under the terms of the agreement, Intas receives the exclusive rights to commercialize Etanercept biosimilar across more than 150 countries worldwide, incl. Europe & the US, for the treatment of various autoimmune diseases. Moreover, mAbxience will be responsible for the development, manufacturing & distribution of the Etanercept biosimilar 
  • The financial terms of the transaction under the collaboration were undisclosed.  


Celltrion Reports the Results for Yuflyma in P-III Trial for the Treatment of Plaque Psoriasis 

Date: Dec 26, 2023 

Product: Yuflyma (biosimilar, Adalimumab) 

  • The P-III interchangeability trial evaluates the safety and efficacy of Yuflyma with its originator drug Humira in patients (n=367) with moderate-to-severe plaque psoriasis  
  • As per the results, Yuflyma depicted an equivalence between the two arms with similar results in PK, efficacy & safety  
  • Based on these results, the company plans to apply to receive interchangeability approval from the US FDA to establish Yuflyma as a biosimilar alternative to Humira. Additionally, Celltrion launched Yuflyma in the US in July & received the US FDA’s approval for 2 different doses in Sep 2023 


The EMA Accepts Formycon’s MAA for FYB203 to Treat Neovascular Age-Related Macular Degeneration (AMD)  

Date: Dec 27, 2023 

Product: FYB203 (biosimilar, aflibercept) 

  • Formycon and its license partner Klinge Biopharma have received the EMA’s acceptance on the MAA submitted for FYB203 (biosimilar Eylea) for the treatment of AMD  

  • Eylea is a long-acting injectable form of aflibercept prescribed to be administered q2month or q4month after the initial dosing period for the treatment of neovascular wet AMD or other retinal diseases

  • The company had previously launched Ranivision (FYB201, biosimilar ranibizumab) for the treatment of neovascular AMD and other retinal diseases in EU 


Celltrion Reports Submission of a Marketing Application to Health Canada for CT-P39 for all Originator Indications 

Date: Dec 28, 2023 

Product: CT-P39 (biosimilar, Omalizumab) 

  • The application was submitted based on the results from the P-III clinical trial evaluating the safety & efficacy of CT-P39 vs Xolair in patients (n=619) with chronic spontaneous urticaria (CSU) across 6 EU countries  
  • Results from the study supporting filling with Health Canada to gain approval for all approved indications of Xolair (Incl. allergic asthma, chronic rhinosinusitis & chronic urticaria)  
  • The originator of CT-P39, Xolair is an antibody developed jointly by Genentech and Novartis. XOLAIR's material patent has expired, Whereas, formulation patent expires in Mar 2024 in EU & Nov 2025 in the US  

Related Post:- Insights+ Key Biosimilars Events of November 2023

Shivani Chandra

Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences 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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