Insights+ Key Biosimilars Events of June 2023

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Insights+ Key Biosimilars Events of June 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 the patients
  • During the month of June, Samsung Bioepis presented results of SB12 (biosimilar, eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria at EHA 2023, STADA and Xbrane reported P-III study results of Ximluci (biosimilar, ranibizumab) for the treatment of neovascular age-related macular degeneration. Our team at PharmaShots has summarized 17 key events of the biosimilar space of June 2023

1. Dr. Reddy Reports the Completion of the P-I Study of DRL_TC, a Proposed Biosimilar of Tocilizumab for Rheumatoid Arthritis

Date- June 05, 2023

Product: DRL_TC

  • The P-I study evaluating PK & PD of proposed tocilizumab biosimilar DRL_TC via the IV route vs US-sourced Actemra (tocilizumab) and EU-sourced RoActemra (tocilizumab)
  • The trial met its 1EPs & 2EPs and showed PK equivalence and similarity in PD parameters, safety, and immunogenicity b/w proposed biosimilar candidate (DRL_TC) and tocilizumab
  • In Dec 2022, the company also highlighted the successful completion of the P-I study of DRL_TC via the SC route. Additionally, the company initiates the P-III study to evaluate the efficacy, safety, tolerability, and immunogenicity of DRL_TC in patients with mod. to sev. active rheumatoid arthritis

2. Rani Therapeutics Expands its Collaboration with Celltrion to Develop Oral Version of Humira Biosimilar RT-105

Date- June 06, 2023

Product: RT-105

  • The recent collaboration was based on Celltrion's previous agreement with Rani in early Jan 2023 to develop an RT-111, an orally administered ustekinumab biosimilar
  • Celltrion will exclusively supply Rani with an oral adalimumab formulation (CT-P17) required for RT-105 & will have a right of first refusal to negotiate a global license to RT-105, based on P-I trial
  • Rani will conduct clinical trials on its proprietary technology for high-dose drug delivery & develop high-concentration oral adalimumab. The company complete the development of CT-P17 & received marketing authorization as 1st high-concentration formulation from the EMA which was recently approved in the US

3. Samsung Biologics Expands its Collaboration with Pfizer for the Long-Term Manufacturing of Biosimilars Portfolio

Date- June 08, 2023

Product: N/A

  • The companies expand their collaboration for the long-term commercial manufacturing of Pfizer’s multi-product portfolio, based on an initial manufacturing agreement signed in Mar 2023 for a specific Pfizer product 
  • Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology & uses its newest facility, Plant 4, for the manufacturing
  • Additionally, Pfizer continues to partner with Samsung Biologics to provide better treatment options for patients globally

4. Samsung Bioepis Presented Results of SB12 (biosimilar, eculizumab) for the treatment of Paroxysmal Nocturnal Hemoglobinuria at EHA 2023

Date- June 08, 2023

Product: SB12 (biosimilar, eculizumab)

  • The company highlighted the results from the population PK/PD/efficacy modeling evaluating SB12 vs eculizumab in patients with PNH
  • The modeling analysis showed similarities of PK, PD, and efficacy profiles b/w SB12 and reference eculizumab in the pooled population of healthy volunteers and patients with PNH thus supporting the totality of evidence on biosimilarity for SB12
  • SB12 received marketing authorization from the EC on May 2023 under the brand name Epysqli, as a biosimilar to Soliris for the treatment of adult and children’s patients with PNH

5. Bio-Thera Solutions Expands its Collaboration with Biomm for BAT2206 (biosimilar, ustekinumab)

Date- June 08, 2023

Product: BAT2206 (biosimilar, ustekinumab)

  • Biomm will get an exclusive right to distribute & market BAT2206 in Brazil & will be responsible for filing the dossier in Brazil. Bio-Thera will lead the global development & commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China
  • The agreement will use Biomm’s strong local presence, sales & marketing capabilities in Brazil. BAT2206 was approved in Brazil for active PsA in adults as monotx. or in combination with methotrexate; for PsO in patients aged 6yrs.; for adult patients with active CD & UC
  • The P-I study of BAT2206 has been completed & is being studied in the P-III study incl. patients from China & Eastern EU countries. Thera & Biomm collaborated to distribute & market BAT1706, a bevacizumab biosimilar in Brazil

6. Alvotech and Teva Settled with Johnson & Johnson for AVT04, a Proposed Biosimilar to Stelara (ustekinumab)

Date- June 12, 2023

Product: AVT04

  • Alvotech & Teva entered into a settlement and license agreement with J&J for AVT04, a proposed biosimilar to Stelara (ustekinumab) in the US. AVT04 can be marketed in the US subject to regulatory approval, no later than Feb 2025 
  • Teva collaborated with Alvotech in 2020 on AVT04 as part of a strategic partnership that covers five biosimilar candidates in the US while Alvotech is responsible for the development, regulatory, and manufacturing & Teva is responsible for commercialization
  • Additionally, J&J has settled its patent infringement lawsuit against Amgen over a proposed ustekinumab biosimilar referencing Stelara where Amgen will be allowed to sell its ustekinumab biosimilar no later than Jan 2025

7. Biogen Reports (PERFUSE) Study Results of SB2 (biosimilar, infliximab) for Chronic Inflammatory Rheumatic Disease

Date- June 12, 2023

Product: SB2 (biosimilar, infliximab)

  • The (PERFUSE) non-interventional study evaluating infliximab (IFX) biosimilar SB2 in 1233 adult patients, showed that SB2 was safe & effective in IFX-naïve patients and in patients who transitioned from prior infliximab reference or biosimilar 
  • Persistence on SB2 in the IFX-naïve/IFX reference/IFX biosimilar cohorts (59%/75%/85% for RA); (64%/87%/83% for PsA) & (56%/80%/80% for axSpA), respectively during 12mos. period. The study was published in Rheumatology Advances in Practice
  • No concerns of immunogenicity & new safety signals were reported with no clinical differences in clinical effectiveness in patients switched from IFX reference or IFX biosimilar to SB2, 56% of IFX-naïve patients continued on SB2 treatment at 12mos. with no changes in the dosing regimen

8. Sandoz Launches Act4Biosimilars Action Plan to Improve Access to Biosimilar Medicines

Date- June 15, 2023

Product: N/A

  • The company launched Act4Biosimilars Action Plan, a global roadmap intended to increase patient access to biological medicines. The action plan has been designed to increase global biosimilar adoption by 30 percentage points in 30+ countries by 2030
  • The Action Plan introduced 12 key initiatives across the 4 areas: approvability, acceptability, accessibility, and affordability. The steps are designed to help local stakeholders create a more favorable environment for biosimilars
  • The Action Plan will incl. a series of reports identifying key challenges by region with the first region being the Americas. Key challenges incl. confusion among patients & healthcare professionals around the interchangeability of regulatory guidelines in the US

9. Biocad CJSC Reports Retrospective Cohort Analysis of BCD-020 (biosimilar, rituximab) for Pediatric Patients with Lupus Nephritis

Date- June 20, 2023

Product: BCD-020 (biosimilar, rituximab)

  • The retrospective cohort analysis published in Biomedicines evaluating BCD-020 in 25 pediatric patients (n=10 boys & 15 girls) who failed conventional non-biologic treatment
  • The results showed that BCD-020 was safe & effective in pediatric patients & minimized the side effects of standard therapy with 80% reductions in SLEDAI, the anti-double-stranded DNA level, proteinuria, hematuria, C4 complement, erythrocyte sedimentation rate, and the median corticosteroid dose, proportion of patients without corticosteroids was reduced after rituximab administration
  • Renal function was improved, the GFR increased & hemodialysis was interrupted in patients who previously required it. BCD-020, the first Russian rituximab biosimilar approved for lymphoma in Russia & some CIS countries

10. Xbrane Reports the US FDA Acceptance of BLA for Lucentis Biosimilar to Treat Serious Eye Diseases

Date- June 21, 2023

Product: Lucentis Biosimilar

  • The US FDA has accepted the BLA filings for Lucentis (ranibizumab) biosimilar candidates for serious eye diseases i.e., wAMD, macular edema, following retinal vein occlusion & myopic choroidal neovascularization. The US FDA set a BsUFA date of April 2024
  • The filing was based on the comprehensive comparative analytical assessment & positive data from a randomized, double-masked, multi-center study evaluating ranibizumab biosimilar in patients with wAMD. The biosimilar candidate was co-developed by Xbrane & STADA
  • The biosimilar candidate met the 1EPs in the study & showed an equivalent efficacy measured in improvement in BCVA at 8wk. over Lucentis with no clinical differences in 2EPs regarding PK, safety & immunogenicity over Lucentis

11. STADA and Xbrane Report P-III Study Results of Ximluci (biosimilar, ranibizumab) for the Treatment of Neovascular Age-Related Macular Degeneration

Date- June 23, 2023

Product: Ximluci (biosimilar, ranibizumab)

  • The P-III study evaluating XSB-001 (IVT) vs reference ranibizumab (0.5mg) in a ratio (1:1) in 582 patients with nAMD across 15 countries incl. the US 
  • The results showed biosimilarity to reference ranibizumab & the treatment with XSB-001 for 52wks. was safe & well tolerated with a safety profile similar to the reference ranibizumab. The study met its 1EPs i.e., the mean BCVA score at baseline was 61.7 vs 61.5 ETDRS letters, and the LS mean change in BCVA from baseline was 4.6 vs 6.4 ETDRS letters at 8wk.
  • At 52wk., LS mean (SE) change in BCVA was 6.4 vs 7.8 letters with no clinical differences b/w treatments in anatomical, safety, or immunogenicity EPs, 4% vs 3% were positive for ADAs, and 11% vs 13% were positive at 52wk.

12. Shanghai Henlius Biotech Receives the NMPA’s IND Approval of HLX13 (biosimilar, ipilimumab) for the Treatment of Hepatocellular Carcinoma

Date- June 26, 2023

Product: HLX13 (biosimilar, ipilimumab)

  • The NMPA has approved the IND application of ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human mAb) for the treatment of HCC. HLX13 was developed by Henlius in accordance with Chinese Biosimilar Guidelines
  • The head-to-head pre-clinical studies results showed a high similarity or no significant difference b/w HLX13 and originator ipilimumab. The company continues to broaden its innovative layout in immuno-oncology combination therapy to bring affordable and high-quality innovative biologics to patients globally
  • HLX13 is designed to block T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells

13. Alvotech Receives Complete Response Letter on Second BLA for AVT02

Date- June 28, 2023

Product: AVT02

  • The US FDA granted a CRL for Alvotech’s second BLA of AVT02, a high-concentration biosimilar candidate for Humira. The agency rejected the drug’s BLA over deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland & no other deficiencies were noted by the US FDA
  • The issues need to be resolved to facilitate the drug’s potential approval. The company plans to resubmit the BLA for AVT02 which will feature additional data supporting an interchangeability designation which would start another 6mos. review period
  • The company focuses to explore options aimed at raising capital, which incl. equity financing and the sale of convertible bonds or other forms of debt financing

14. Formycon AG and its License Partner Klinge Biopharma GmbH Report the BLA Submission of FYB203 (biosimilar, aflibercept) to the US FDA

Date- June 29, 2023

Product: FYB203 (biosimilar, aflibercept)

  • Formycon AG and its license partner Klinge Biopharma GmbH submit BLA for FYB203, a biosimilar candidate for Eylea
  • Eylea is indicated for the treatment of nAMD and other severe retinal diseases & inhibits 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

15. Boehringer Ingelheim Reports the Commercial Availability of Cyltezo, an Interchangeable Biosimilar to Humira

Date- June 30, 2023

Product: Cyltezo

  • The company launches Cyltezo, a US FDA-approved interchangeable biosimilar to Humira in the US for multiple chronic inflammatory diseases. Cyltezo is available as a prefilled syringe or an autoinjector pen
  • The efficacy & safety of Cyltezo were based on the P-III randomized (VOLTAIRE-X) trial evaluating the effect of multiple switches b/w Humira & Cyltezo vs continuous treatment with Humira. The results showed PK equivalence with highly similar efficacy & immunogenicity, and comparable safety was observed in patients who received Humira continuously or who switched b/w Humira & Cyltezo
  • Cyltezo was approved as a biosimilar in 2017 for multiple chronic inflammatory diseases & was approved as an interchangeable biosimilar in 2021

16. Celltrion Launches Yuflyma (biosimilar, adalimumab) in the US

Date- June 30, 2023

Product: Yuflyma (biosimilar, adalimumab)  

  • The company launch Yuflyma (adalimumab-aaty) for the treatment of 8 conditions: RA, JIA, PsA, AS, CD, UC, PsO, and HS. Yuflyma is a high-concentration (100mg/mL) & a citrate-free adalimumab biosimilar
  • The biosimilar is available in auto-injector and prefilled syringe options. Yuflyma became commercially available among key distributors across the US & has a longer shelf life than Humira maintaining stability at 25℃ (77°F) for 30 days, and is administered via a latex-free device.
  • Additionally. the company also provided the patient support program Celltrion CONNECT along with Celltrion CARES Co-pay Assistance Program that will commence on July 10

17. Celltrion Seeks Marketing Authorization for CT-P42 (biosimilar, aflibercept) in the US

Date- June 30, 2023

Product: CT-P42 (biosimilar, aflibercept)

  • The company has filed an NDA with the US FDA for CT-P42, a biosimilar referencing Eylea (aflibercept) to treat patients with ocular diseases & apply for marketing authorization for all Eylea's indications, excl. wAMD and DME, based on the P-III trial results
  • The P-III trial results showed confirmed equivalence and similarity to the Eylea. The company also plans to file for approval of CT-P42 in other key global markets, incl. EU
  • Additionally, the drug's exclusivity rights in the US expire in May 2024, and its patents in EU in Nov 2025. The company plans to complete global license applications for ~5 biosimilars, incl. CT-P42 within the year

Related Post: Insights+ Key Biosimilars Events of May 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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