Insights+ Key Biosimilars Events of September 2023

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Insights+ Key Biosimilars Events of September 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 September, Sandoz entered into a development and commercialization agreement with Samsung Bioepis for SB17, a proposed biosimilar to Stelara, Fresenius Kabi’s Tyenne (biosimilar, tocilizumab) received EC’s approval for multiple inflammatory and immune-mediated conditions. Our team at PharmaShots has summarized 11 key events of the biosimilar space of September 2023

1. Formycon Reports the US FDA Acceptance of BLA for FYB203 (biosimilar, aflibercept) to Treat Retinal Diseases

Date- Sept 01, 2023

Product: FYB203 (biosimilar, aflibercept)

  • The US FDA has accepted the BLA for FYB203 (biosimilar, aflibercept) for the treatment of severe retinal diseases. The US FDA’s decision is expected in June 2024
  • Eylea is indicated for the treatment of nAMD and other severe retinal diseases that inhibit vascular endothelial growth factor for the excessive formation of blood vessels in the retina
  • Additionally, six biosimilars are currently being developed by Formycon. The company is also working on the development of FYB207, based on its extensive experience in the development of biopharmaceutical drugs

2. Sandoz Entered into a Development and Commercialization Agreement with Samsung Bioepis for SB17, a Proposed Biosimilar to Stelara

Date- Sept 11, 2023

Product: SB17

  • Under the terms of the agreement, Sandoz gets an exclusive right to commercialize SB17, a proposed biosimilar to Stelara (ustekinumab) in the US, Canada, EEA, Switzerland, and UK. Stelara, a fully human mAb to interleukin (IL)-12/23 was approved for the treatment of autoimmune diseases i.e., PsO, PsA, CD, and UC
  • The agreement strengthens Sandoz's position in immunology and supports further pipeline expansion. The substance patents were set to expire in Sept 2023 in the US and July 2024 in the EU
  • The P-I clinical study of SB17 presented at AAD 2023 showed PK equivalence and comparable safety, tolerability, immunogenicity profiles b/w SB17 and reference ustekinumab

3. BioFactura Reports P-I Study Results of BFI-751 (biosimilar, ustekinumab)

Date- Sept 12, 2023

Product: BFI-751 (biosimilar, ustekinumab)

  • The P-I study results published in the peer-reviewed journal, Clinical Pharmacology in Drug Development evaluating PK profiles of BFI-751 vs EU & US ustekinumab in 216 healthy adult volunteers
  • All 3 treatments met the standard BE criteria that is CI: 90% of the geometric mean ratios of AUC (0-infinity), AUC (0 to Cmax), and maximum concentration are completely within the acceptance interval
  • No differences in the safety, immunogenicity & tolerability profiles were seen with no difference in the overall incidence of injection site reactions after dosing among treatment groups. BioFactura & CuraTeQ sign exclusive license for BFI-751, a biosimilar to Stelara on July 2023

4. Sandoz Receives the EMA’s CHMP Positive Opinion of Biosimilar Trastuzumab for Breast and Gastric Cancer

Date- Sept 18, 2023

Product: Biosimilar Trastuzumab

  • The EMA’s CHMP granted a positive opinion recommending marketing authorization of the biosimilar trastuzumab (150mg, IV) to treat HER2+ metastatic breast & gastric cancer. Trastuzumab was developed by EirGenix and is licensed by Sandoz
  • The opinion was based on the comprehensive analytical, preclinical, and clinical results incl. evidence derived from an extensive analytical characterization along with results from a P-I PK/PD study and a confirmatory P-III study in breast cancer patients
  • Both studies met their 1EPs & showed that the biosimilar was non-inferior to the reference biologic in terms of PK, efficacy, safety, and immunogenicity

5. Rani Therapeutics Initiates P-I Study of RT-111 (biosimilar, ustekinumab) for Autoimmune Diseases

Date- Sept 19, 2023

Product: RT-111 (biosimilar, ustekinumab)

  • The company initiates the P-I trial to evaluate RT-111, an orally administered RaniPill GO capsule containing a ustekinumab biosimilar CT-P43 in ~55 healthy human patients. The trial will consist of 3 cohorts with 2 cohorts evaluating RT-111 at a dose of 0.5 or 0.75mg, administered as a RaniPill capsule containing ustekinumab & third cohort will receive Stelara (0.5mg, SC)
  • The trial focuses on evaluating the PK, safety & tolerability of RT-111. The results are expected early in Q1’24
  • Ustekinumab, a human IgG1қ mAb that binds with specificity to the p40 protein subunit & is marketed in the US as Stelara. Rani & Celltrion collaborated on Jan 2023 for the development of RT-111 (biosimilar, ustekinumab)

6. Fresenius Kabi’s Tyenne (biosimilar, tocilizumab) Receives EC’s Approval for Multiple Inflammatory and Immune-Mediated Conditions

Date- Sept 20, 2023

Product: Tyenne (biosimilar, tocilizumab)

  • The EC has granted marketing authorization for tocilizumab biosimilar Tyenne to treat multiple inflammatory & immune-mediated conditions, incl. RA, giant cell arteritis, polyarticular JIA, and systemic juvenile idiopathic arthritis, CRS as well as for COVID-19
  • The company also received EC approval for both SC (prefilled syringe and autoinjector) & IV formulations which provide comprehensive, alternative treatment solutions for healthcare professionals & patients
  • Fresenius Kabi’s Tyenne, the third approved biosimilar in the EU expanding its biosimilar portfolio focused on autoimmune diseases & oncology. The company offers a comprehensive patient support program KabiCare which will be available to patients & healthcare providers from its launch in the EU

7. Meitheal Entered into an Exclusive License Agreement with Tonghua Dongbao Pharmaceutical to Commercialize Three Insulin Biosimilars in the US

Date- Sept 21, 2023

Product: Insulin Biosimilars

  • The companies collaborated to commercialise three insulin biosimilars i.e., insulin lispro and insulin aspart, and the long-acting insulin glargine in the US
  • Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical will get an exclusive US marketing right to commercialize biosimilar versions of insulin aspart, insulin lispro, and insulin glargine upon the US FDA approval which is expected in 2026
  • Additionally, Tonghua Dongbao and Nanjing King-Friend Biochemical will lead the development and supply of all three insulin biosimilars while all three companies will also share the royalties from the US sales

8. Biocon Biologics’ Yesafili (biosimilar, aflibercept) Receives EC’s Approval for Ophthalmic Conditions

Date- Sept 22, 2023

Product: Yesafili (biosimilar, aflibercept)

  • The EC has granted marketing authorization for Yesafili, a biosimilar of Aflibercept for the treatment of patients with age-related macular degeneration and diabetic macular edema
  • Yesafili is intended for the treatment of neovascular (wet AMD), visual impairment due to macular oedema secondary to RVO, visual impairment due to DME, and myopic CNV
  • Yesafili was highly similar to the reference aflibercept & the results showed that Yesafili has comparable quality, safety, and efficacy to Eylea. The centralized marketing authorization is valid in all EU Member States, EEA countries Iceland, Liechtenstein, and Norway

9. CinnaGen Reports P-III Clinical Trial Results of Melitide (biosimilar, liraglutide) for the Treatment of Type 2 Diabetes

Date- Sept 22, 2023

Product: Melitide (biosimilar, liraglutide)

  • The new results from a P-III trial evaluating biosimilar liraglutide vs Victoza showed that biosimilar liraglutide was non-inferior in efficacy to the reference Victoza with a comparable safety profile
  • The results demonstrated a similar lowering of HbA1c levels over 26wks. of treatment, as well as comparable effects on body weight, lipid profile, blood pressure, and the incidence of AEs, mean changes in HbA1C (− 1.76% vs − 1.59%)
  • Similar findings were obtained with the intention-to-treat analysis with no significant differences b/w two study arms & none of the patients developed anti-liraglutide Abs. Liraglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) used for glycemic control in adults with T2D & was approved in the US in Jan 2010

10. Fuji Pharma Receives the MHLW Approval of AVT04 (biosimilar, ustekinumab) in Japan

Date- Sept 25, 2023

Product: AVT04 (biosimilar, ustekinumab)

  • The MHLW has approved AVT04 (ustekinumab), a biosimilar to Stelara for autoimmune conditions. AVT04 was developed using an Sp2/0 host cell line and is manufactured using a continuous perfusion process
  • Alvotech and Fuji have a joint commitment to increase patient access to vital biologic medicines. Under the 2018 agreement, Alvotech is responsible for development and manufacturing and Fuji Pharma got an exclusive commercialization right in Japan
  • AVT04 is a mAb and a biosimilar candidate to Stelara which binds to two cytokines, IL-12 and IL-23 involved in inflammatory and immune responses

11. Sandoz Receives EC’s Marketing Authorization for Biosimilar Tyruko to Treat Multiple Sclerosis

Date- Sept 26, 2023

Product: Biosimilar Tyruko

  • The EC has granted marketing authorization for the first and only biosimilar Tyruko to treat relapsing forms of MS. Tyruko was developed by Polpharma Biologics & will be commercialized by its collaboration partner Sandoz 
  • The decision was based on evidence from extensive analytical characterization in addition to P-I & confirmatory P-III studies. Both studies met their 1EPs & showed similarity of the biosimilar with reference biologic in terms of PK, efficacy, safety & immunogenicity
  • In 2019, Sandoz & Polpharma Biologics collaborated for biosimilar natalizumab where Polpharma Biologics will maintain responsibilities for the development of medicine, manufacturing & supply of drug substances. Sandoz gets the rights to commercialize & distribute in all markets

Related Post: Insights+ Key Biosimilars Events of August 2023

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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