Shots:

• 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 November, Amgen received US FDA approval for Wezlana, biosimilar of ustekinumab & Stada and Alvotech received positive CHMP opinion for Uzpruvo, biosimilar of Stelara. Our team at PharmaShots has summarized 11 key events of the biosimilar space of November 2023 

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

Date: Nov 1, 2023 

Product: Wezlana (biosimilar, ustekinumab) 

• 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 

2. Fresenius Kabi Launches Tyenne (Biosimilar, Tocilizumab) in the EU for the Treatment of Multiple Inflammatory and Immune Diseases 

Date: Nov 1, 2023 

Product: Tyenne (biosimilar, Tocilizumab) 

• Fresenius Kabi has launched Tyenne, first tocilizumab biosimilar, in the EU to treat inflammatory and immune diseases, incl. rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome (CRS) and COVID-19  

• Tyenne offers flexible administration options with SC (PFS and autoinjector) and IV (vials) delivery methods, contributing to patient access and healthcare system sustainability 

• KabiCare, Fresenius Kabi's patient support program, is accessible to patients and HCPs in the EU from the launch, emphasizing their dedication to providing comprehensive assistance 

3. The US FDA Accepted to Review Samsung Bioepis & Organon’s sBLA for Hadlima (Biosimilar, adalimumab) to Treat Plaque Psoriasis 

Date: Nov 9, 2023 

Product: Hadlima (biosimilar, adalimumab) 

• The sBLA submission was based on the results from the P-IV clinical trial (NCT05510063) evaluating the PK of Hadlima in 2 treatment groups of patients with severe plaque psoriasis who alternatively received high-concentration formulations of Humira or Hadlima vs patients receiving Humira continuously 

• Samsung Bioepis submitted the sBLA for Hadlima, a TNF blocker, to the US FDA in Aug’23 post which the filling has progressed for interchangeability designation 

• Earlier in Jul’19, Hadlima received the US FDA’s approval as a low-concentration (40 mg/0.8 mL) formulation of the prefilled syringe & prefilled autoinjector whereas its high concentration (40 mg/0.4 mL) formulation was approved in Aug’22 (marketed across the US by Organon) 

4. Stada and Alvotech Receives CHMP’s Positive Opinion for Uzpruvo (Biosimilar, Stelara)  

Date: Nov 10, 2023 

Product: Uzpruvo (biosimilar, Stelara) 

• Stada and Alvotech have received positive CHMP opinion for Uzpruvo (AVT04), a biosimilar to Stelara (ustekinumab), for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis, the MAA of which will be valid in the EU states as well as in Iceland, Liechtenstein and Norway 

• The MAA was based on analytical and clinical data from the AVT04-GL-301 study in which Uzpruvo depicted therapeutic equivalence to Stelara for moderate to severe chronic plaque-type psoriasis 

• Ustekinumab, human IgG1κ mAb, will be developed and manufactured by Alvotech while STADA will be responsible for the commercialization within the EU under their agreement signed in 2019 

5. Lupin and Amman Pharma Signs an Exclusive Agreement for Licensing and Supply of Ranibizumab (Biosimilar, Lucentis) 

Date: Nov 10, 2023 

Product: Ranibizumab (biosimilar, Lucentis) 

• Lupin has entered an exclusive partnership with Amman Pharma for the marketing and commercialization of ranibizumab, biosimilar of Lucentis, in the Middle East region, incl. Jordan, Saudi Arabia, UAE, Iraq, Lebanon, & other GCC countries 

• The biosimilar is indicated for the treatment of Neovascular (Wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV) 

• Ranibizumab is a recombinant humanized mAb fragment (IgG1) designed to bind to and block the activity of vascular endothelial growth factor A (VEGF-A) 

6. Alvotech and JAMP Pharma Receives Health Canada Approval for Jamteki (Biosimilar, Stelara) 

Date: Nov 14, 2023 

Product: Jamteki (Biosimilar, Stelara) 

• Alvotech and JAMP Pharma have received marketing authorization from Health Canada for Jamteki (AVT04), developed by the former company 

• Jamteki has been approved in two presentations: a 45mg/0.5mL pre-filled syringe with a passive safety device for subcutaneous injection (PFS-SD) and a 90mg/mL PFS-SD 

• Jamteki, mAb and biosimilar to Stelara (ustekinumab), targets IL-12 and IL-23 involved in inflammatory responses. It is approved in Japan and Canada while EMA recommended market authorization in the EU, Norway, Iceland, and Liechtenstein 

7. Sandoz Introduces High-Concentration Formulation of Hyrimoz in Europe 

Date: Nov 21, 2023 

Product: Hyrimoz (biosimilar, Humira) 

• The company has launched Hyrimoz (biosimilar, Humira) citrate-free high-concentration formulation (100 mg/mL) in the EU indicated for rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa  

• In contrast to the existing Hyrimoz (50 mg/mL) formulation, Hyrimoz HCF, a revised formulation (100 mg/mL) that provides a 50% reduction in injection volume, potentially reducing the no. of injections needed for patients who require 80 mg/mL or higher dose, the formulation is administered using the well-known Hyrimoz SensoReady pen 

• This launch will strengthen the company’s biosimilar portfolio in its immunology pipeline  

8. EirGenix’s Biosimilar Trastuzumab Received Market Authorization from the European Commission (EC) 

Date: Nov 23, 2023 

Product: Trastuzumab (biosimilar. Herceptin) 

• Trastuzumab received market authorization in the EU for the treatment of HER2-positive breast cancer & metastatic gastric cancers. These are the same indications that the EC has authorized for the reference biologic, Herceptin 

• The market authorization following the EU’s CHMP positive opinion was based on the P-III study that evaluated EG12014 vs trastuzumab in patients with HER2-positive, early-stage breast cancer patients (n=807) 

• Sandoz is responsible for the commercialization of drug worldwide (excl. Taiwan, China, Russia, and some Asian countries) whereas EirGenix takes over the development & manufacturing of trastuzumab 

9. Formycon and its License Partner Klinge Biopharma Reports the BLA Submission of FYB203 (Biosimilar, Eylea) to the EMA 

Date: Nov 27, 2023   

Product: FYB203 (biosimilar, Eylea) 

• Formycon and its license partner Klinge Biopharma submitted the BLA for FYB203, a biosimilar candidate for Eylea (aflibercept) 

• Eylea targets vascular endothelial growth factor (VEGF) and is indicated for the treatment of neovascular age-related macular degeneration (nAMD) and other severe retinal diseases  

• Additionally, six biosimilars are currently being developed by Formycon. The company is also working on the development of COVID-19 drug, FYB207, based on its extensive experience in the development of biopharmaceutical drugs 

10. Alvotech Reports Topline Results from the Study of AVT05 (Biosimilar, Simponi and Simponi Aria) 

Date: Nov 29, 2023 

Product: AVT05 (biosimilar, Simponi and Simponi Aria) 

• Alvotech has announced top-line results from a PK trial investigating AVT05, a biosimilar candidate for Simponi & Simponi Aria (golimumab) 

• The trial met its 1EP which was commenced by the company in May 2023 to compare the efficacy, safety, and immunogenicity of AVT05 and Simponi to treat adults with moderate to severe rheumatoid arthritis 

• AVT05, mAb targeting TNF alpha, has not gained regulatory approval, and bio similarity is yet to be established by authorities  

11. Bio-Thera Reported Positive Results of BAT2206 (Biosimilar, Stelara) in P-III Study for Patients with Plaque Psoriasis 

Date: Nov 29, 2023 

Product: BAT2206 (biosimilar, Stelara) 

• The P-III (NCT04728360) study evaluates safety, efficacy, immunogenicity & PK of BAT2206 with Stelara in patients (n=556) with moderate to severe plaque psoriasis 

• The 1EP of the study was improvement in the PASI score from the baseline to wk12. The results of the study will be presented at future medical meetings & publication 

• BAT2206 is a human mAb that suppresses the bioactivity of human IL-12 and IL-23 by inhibiting shared p40 from binding to the IL-12Rβ1 receptor protein found on the surface of immune cells. It is developed by Bio-Thera and commercialized by Hikma in the US 

Related Post: Insights+ Key Biosimilars Events of October 2023