Insights+ Key Biosimilars Events of August 2023

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Insights+ Key Biosimilars Events of August 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 August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s approval as the first biosimilar for relapsing forms of multiple sclerosis, Sandoz’ Biosimilar Aflibercept met primary endpoints in the P-III study (MYLIGHT) for wet macular degeneration. Our team at PharmaShots has summarized 11 key events of the biosimilar space of August 2023

1. Samsung Bioepis and Organon Report Interchangeability Study Results of SB5 (biosimilar, adalimumab) for Chronic Plaque Psoriasis

Date- Aug 02, 2023

Product: SB5 (biosimilar, adalimumab)

  • The results from the interchangeability P-IV study of SB5 across 33 sites in 4 countries (Bulgaria, Czechia, Lithuania, Poland). The primary objective of the study was to evaluate the PK similarity b/w 2 treatment groups in patients who switched multiple times b/w Humira (ADL) and high-concentration SB5 vs patients receiving ADL continuously
  • The study achieved all 1EPs (PK endpoints of AUCtau and Cmax at 23-25wk.) while efficacy profiles, safety profiles, and immunogenicity were also comparable b/w 2 treatment groups
  • SB5 was approved in the US under the brand name Hadlima as a low-concentration (50mg/mL) formulation of the prefilled syringe and autoinjector while a high-concentration (100 mg/mL) formulation was approved in August 2022

2. Formycon and Fresenius Kabi Settled with Johnson & Johnson for FYB202, a Proposed Biosimilar to Stelara (ustekinumab)

Date- Aug 07, 2023

Product: FYB202

  • Formycon and Fresenius Kabi entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed ustekinumab biosimilar in the US. FYB202 can be marketed in the US subject to regulatory approval, no later than April 2025
  • FYB202, a human mAb that targets the cytokines interleukin-12 and interleukin 23 for immune-mediated disorders. Stelara was approved for mod. to sev. PsO, CD, UCas well as active PsA
  • Formycon seeks to submit the BLA in 2023. Formycon & Fresenius Kabi collaborated in Feb 2023 to commercialize the proposed ustekinumab biosimilar (FYB202) in key global markets after successful approvals while both companies share equal post-commercialization value\

3. Innovent and Eli Lilly Report Real-World Analysis of Sintilimab and Bevacizumab Biosimilar for Hepatocellular Carcinoma

Date- Aug 08, 2023

Product: Sintilimab and Bevacizumab Biosimilar

  • The real-world analysis evaluating sintilimab (200mg, q3w) + bevacizumab biosimilar (15mg/kg) in patients with advanced HCC
  • The results confirmed the promising efficacy, tolerable toxicity, and cost-effectiveness in Chinese patients with aHCC who received sintilimab + bevacizumab, m-OS & m-PFS were 344.00 & 238.00 days, AEs were reported in 51.5%, incl. 9 patients with grade ≥3, life-year and quality-adjusted LY were 1.97 and 2.92
  • The results published in the Journal of Cancer Research and Clinical Oncology demonstrated the clinical benefits of sintilimab + bevacizumab. At the time of best response status, no patients achieved CR; PR in 8 patients and SC (51 patients); 9 experienced disease progression (ORR, 11.8%; DCR, 86.8%), treatment-related AEs (51.5%)

4. Shanghai Biomabs Pharmaceutical Reports P-III Study Results of CMAB008 (biosimilar, infliximab) for Rheumatoid Arthritis

Date- Aug 14, 2023

Product: CMAB008 (biosimilar, infliximab)

  • The P-III study evaluates CMAB008 (3mg/kg, IV) vs infliximab (3mg/kg) at 0, 2, 6, 14, 22, and 30wks. across 31 centers in China
  • The results showed non-inferior efficacy of CMAB008 vs infliximab with similar early and lasting therapeutic effects, and the equivalence is further demonstrated. The therapy was well tolerated & the results were published in Rheumatology and Therapy.
  • 57.6% vs 62.2% achieved ACR20 at 30wk. while the 2EPs incl. safety, efficacy, immunogenicity, and PK were also highly similar, 82.4% had 1 TEAE with comparable frequencies b/w CMAB008 cohort (83.3%) and the infliximab cohort (81.5%), frequency of TEAEs leading to discontinuation or dose reduction, severe AEs and infusion reaction were similar across treatment groups

5. Sandoz’ Biosimilar Aflibercept Meet Primary Endpoints in the P-III Study (MYLIGHT) for the Treatment of Wet Macular Degeneration

Date- Aug 15, 2023

Product: Biosimilar Aflibercept

  • The P-III trial (MYLIGHT) evaluated the efficacy and safety study of biosimilar aflibercept vs Eylea in a ratio (1:1) in 485 patients across 16 countries for 48wk., followed by a safety follow-up period of 4wks.
  • The study met its primary efficacy & showed therapeutic equivalence in the mean change of BCVA from baseline to 8wk. b/w biosimilar aflibercept and Eylea while the safety, immunogenicity, and PK results further confirmed no clinical difference
  • The company plans to file for regulatory approval for biosimilar aflibercept in the US and EU in the coming months & has 8 marketed biosimilars with 24 assets in various stages of development

6. Senju Pharmaceutical Highlighted Study Results of Ranibizumab Biosimilar for Neovascular Age-Related Macular Degeneration

Date- Aug 15, 2023

Product: Ranibizumab Biosimilar

  • The study published in Ophthalmology and Therapy evaluating ranibizumab biosimilar (RBZ BS) in patients with nAMD
  • The results showed that ranibizumab biosimilar was found to be the most cost-effective when used in treat-and-extend (TAE) regimens and pro re nata (PRN) regimens and best societal care (BSC) compared to other anti-VEGF treatments, acc. to a recent Japanese study
  • The magnitude of difference in 2yr. treatment frequencies b/w (RBZ BS) TAE and AFL TAE in the indirect comparison study was 5.9 times higher which was larger than the predicted outcome from real-world practice as suggested by retrospective observational studies conducted in Japan and other foreign settings

7. Alvotech Highlighted 52wk. Study Results of AVT04 (biosimilar, ustekinumab) for Chronic Plaque Psoriasis

Date- Aug 18, 2023

Product: AVT04 (biosimilar, ustekinumab)

  • The 52wk. study evaluating the safety, efficacy, tolerability, immunogenicity, and PK b/w AVT04 and originator ustekinumab in a ratio (1:2) in patients with mod. to sev. chronic PsO
  • The results showed the therapeutic equivalence b/w AVT04 and reference ustekinumab. The study met its 1EPs & showed PASI improvement was 87.3% vs 86.8% & the incidence of Abs to ustekinumab had no clinically meaningful impact, the proportion of patients who achieved PASI50, PASI75, PASI90, and PASI100 before and after switching was similar across treatment arms with no clinically significant differences
  • 34.5% vs 33.6% experienced TEAEs. Ustekinumab, an interleukin-12 (IL-12) and IL-23 inhibitor was approved to treat a variety of inflammatory diseases, incl. PsO

8. CinnaGen Reports Study Results of Biosimilar Teriparatide for the Treatment of Osteoporosis

Date- Aug 24, 2023

Product: Biosimilar Teriparatide

  • The study evaluating biosimilar teriparatide (20μg, qd) in 239 patients, showed an improvement in bone mineral density (BMD) in patients with osteoporosis treated for a year or more according to Bone Reports, patients received biosimilar teriparatide for 12-16/17-20/21-24mos. were 27.62%/14.64%/57.74%, respectively
  • T-score (SD) at lumbar spine & femoral neck increased from ­–2.67 to –2.26 & ­2.18 to –2.09; patients with maintained or improved BMD T-score at both sites were 85.36% & 69.04%. Similar results were obtained in subgroups of patients with RA & those with a history of a previous fracture or parental hip fracture
  • Biosimilar teriparatide can be considered an effective treatment option in female and male patients with osteoporosis

9. Kern Pharma Highlighted P-IV Study Results of CT-P13 (biosimilar, infliximab) for Rheumatic Disease

Date- Aug 24, 2023

Product: CT-P13 (biosimilar, infliximab)

  • The P-IV open-label, multicenter study evaluating CT-P13 in 30 adult patients with rheumatic disease incl. PsA, RA, and AS across 10 study centers in Thailand. CT-P13 was administered via 2h IV infusions at doses approved for use in Thailand (3mg/kg for RA; 5mg/kg for AS and PsA)
  • The results showed that the therapy was found to be well tolerated and effective across indications, acc. to a study published in Future Medicine, disease activity improved by 16wk. was maintained through the end of the treatment period, 2 patients discontinued treatment with CT-P13 during the study period
  • No cases of malignancy, drug-induced liver disease, or tuberculosis during the treatment and follow-up periods were observed

10. Sandoz’ Tyruko (biosimilar, natalizumab) Receives the US FDA’s Approval as First Biosimilar for Relapsing Forms of Multiple Sclerosis

Date- Aug 25, 2023

Product: Tyruko (biosimilar, natalizumab)

  • The US FDA has approved Tyruko, the first biosimilar to Tysabri (natalizumab) for all indications covered by reference medicine with the same dosing and administration schedule for relapsing forms of MS incl. CIS, RRMS, and active secondary progressive disease, as well as Crohn’s disease in adults
  • The approval was based on robust P-I & III clinical studies which met their 1EPs and showed Tyruko provides the same risks and benefits in terms of efficacy, safety, and immunogenicity as reference Tysabri
  • The biosimilar treatment is available via a Risk Evaluation and Mitigation Strategy (REMS) program due to the identified risk of the viral infection progressive multifocal leukoencephalopathy (PML)

11. Alvotech and Bioventure Receives Approval of AVT02 (biosimilar, adalimumab) from Egyptian Drug Authority in Egypt

Date- Aug 29, 2023

Product: AVT02 (biosimilar, adalimumab)

  • Alvotech and Bioventure have received approval from the Egyptian Drug Authority to manufacture and distribute AVT02, a biosimilar for Humira for the treatment of RA and multiple other inflammatory diseases, under the trade name Adalimumab-EVA
  • Alvotech will lead the development and production of the product while Bioventure is responsible for commercialization. Alvotech’s focuses on increasing patient access globally to more affordable biologics
  • Bioventure serves as the strategic partner of Alvotech for marketing AVT02 and other biosimilar candidates in the MENA regions. AVT02 is currently marketed in multiple EU countries and Canada

Related Post: Insights+ Key Biosimilars Events of July 2023


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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