Insights+ Key Biosimilars Events of April 2023

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Insights+ Key Biosimilars Events of April 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 April, Sandoz’s Hyrimoz (biosimilar, adalimumab) received EC’s marketing authorization for multiple indications, Accord BioPharma reported the US FDA acceptance of BLA for HLX02, a proposed trastuzumab biosimilar for gastric cancer and other indications. Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023

1. Eli Lilly Launches Rezvoglar as Second Interchangeable Insulin Biosimilar in the US

Date- April 01, 2023

Product: Rezvoglar

  • The company launched Rezvoglar, a second interchangeable biosimilar insulin product to Lantus (insulin glargine) in the US market for the treatment of patients with diabetes. Rezvolgar will launch at a 78% discount to the reference Lantus
  • Insulin glargine products are used to improve glycemic control in adult and pediatric patients with T1D and in adults with T2D. Additonally, Rezvoglar was also approved in the US on Nov 2022
  • In addition to Rezvoglar, Lilly is the owner of Humulin (recombinant human insulin), Humalog (reference insulin lispro), as well as an unbranded insulin lispro product

2. STADA and Xbrane Launch Ximluci (biosimilar, ranibizumab) for Ophthalmic Conditions in the EU

Date- April 03, 2023

Product: Ximluci (biosimilar, ranibizumab)

  • STADA & Xbrane launch Ximluci, a ranibizumab biosimilar in multiple EU countries for several ophthalmic conditions. Ximluci is supplied as a 2.3mg/0.23 mL single-use vial inj. for IVT use
  • The marketing authorization was based on data frsom a comparative analytical assessment & P-III trial of Ximluci vs Lucentis in 580 patients with wet AMD which showed equivalent efficacy & comparable safety to the reference product. The P-III study achieved the 1EPs as the adjusted treatment differences b/w products were within the predefined equivalence margin
  • Under the July 2018 agreement, both companies are responsible for the development & manufacturing of the biosimilars while STADA holds the marketing authorization & commercial rights in the EU & other international markets

3. Celltrion Reports 24 Week P-III Trial Results of CT-P42 (biosimilar, aflibercept) for Wet Age-Related Macular Degeneration and Diabetic Macular Edema

Date- April 03, 2023

Product: CT-P42 (biosimilar, aflibercept)

  • The company highlighted the 24wk. results from the P-III clinical trial of CT-P42, a biosimilar referencing Eylea. The results showed that CT-P42 met the predefined equivalence criteria of ±3 letters, and 2EPs of efficacy, safety, and immunogenicity also showed similar trends to Eyela
  • Eylea is expected to reach substance patent expiration in the US in June 2023 and in the EU in May 2025. The company plans to complete the remaining P-III studies of CT-P42 and file for product license in the US and EU in 2023
  • Additionally, the company also conducts a 52wk. trial in 348 patients for the treatment of DME in 13 countries, incl. Germany and Spain

4. Mabwell’s Mailishu (biosimilar, denosumab) Receives the NMPA’s Approval for the Treatment of Osteoporosis in China

Date- April 03, 2023

Product: Mailishu (biosimilar, denosumab)

  • The NMPA has approved Mailishu, a denosumab biosimilar for the treatment of postmenopausal women with osteoporosis who are at high risk of fracture. Mailishu was developed by Mabwell’s wholly-owned subsidiary T-Mab
  • Mailishu is the second approved biosimilar to denosumab, following the NMPA’s approval of Luye Pharma Group’s Boyobei (denosumab) in Nov 2022. Denosumab was marketed by Amgen under the trade names Prolia and Xgeva
  • Additionally, Mailishu is designed to reduce the risk of vertebral, non-vertebral, and hip fractures within this patient segment

5. Sandoz’s Hyrimoz (biosimilar, adalimumab) Receives EC’s Marketing Authorization for Multiple Indications

Date- April 04, 2023

Product: Hyrimoz (biosimilar, adalimumab)

  • The EC has granted marketing authorization for Hyrimoz (adalimumab-adaz) high-concentration formulation, a biosimilar to Humira (adalimumab) in the EU. Hyrimoz has been approved for use in all the indications covered by the reference Humira, incl. PsO, RA, UC, CD, uveitis & hidradenitis suppurativa
  • The results from a P-I PK bridging study evaluating adalimumab (50mg/mL) vs citrate-free HCF (100mg/mL) showed that the study met all of the primary objectives confirming similar safety, immunogenicity & PK of Hyrimoz 50mg/mL & the high-concentration formulation
  • Sandoz continues to expand patient access to much-needed medications, increase healthcare savings, and fuel innovation through increased competition

6. Accord BioPharma Reports the US FDA Acceptance of BLA for HLX02, a Proposed Trastuzumab Biosimilar for Gastric Cancer and Other Indications

Date- April 05, 2023

Product: HLX02

  • The US FDA has accepted the BLA for HLX02, a proposed trastuzumab biosimilar for adjuvant treatment of HER2-overexpressing gastric cancer & other indication. HLX02 was originally developed by Accord's business partner Shanghai Henlius Biotech
  • The submission was based on robust structural and functional analytical comparison data using multiple orthogonal techniques & head-to-head clinical studies b/w HLX02 & reference trastuzumab. These incl. comparative analytical studies, nonclinical studies, a P-I PK similarity study & a P-III study
  • The results showed high similarity in quality, safety, & efficacy b/w HLX02 & reference trastuzumab. Additionally, the company intends to launch many additional biosimilars in the US market over the next 5yrs.

7. Intas Pharmaceuticals Reports Retrospective Study Results of Razumab (biosimilar, ranibizumab) for the Treatment of Retinopathy of Prematurity

Date- April 08, 2023

Product: Razumab (biosimilar, ranibizumab)

  • The retrospective study from India showed that Razumab, a ranibizumab biosimilar was safe & effective to use in infant patients. Among the results from 118 eyes of 59 infants with a median gestational age of 30wks, APROP was found in 28 eyes (24%) of 14 babies, stage 3 disease in zone 1 in another 28 eyes (24%) & 62 eyes (52%) had stage 3 ROP in zone 2 posterior region
  • Complete resolution of ROP along with complete vascularization was seen in 22 eyes (19%) at a median of 55 days, 35% showed a recurrence in neovascularization & received repeat inj. at a median of 51 days post-inj.
  • 45% of eyes did not develop recurrence or complete vascularization after 6wks. and required laser treatment to the residual avascular retina, no infants died or experienced TRAEs

8. Celltrion Reports Preliminary Results from the P-III Clinical Trial of CT-P39 (biosimilar, omalizumab) for Allergic Asthma and Chronic Urticaria

Date- April 10, 2023

Product: CT-P39 (biosimilar, omalizumab)

  • The company highlighted the preliminary data from a P-III clinical trial evaluating omalizumab biosimilar CT-P39 in patients with chronic spontaneous urticaria
  • The results showed that CT-P39 met the pre-defined equivalence criteria and demonstrated similar results to Xolair in terms of efficacy, safety, immunogenicity, and PK. Xolair’s substance patent has already expired and the formulation patent is set to expire in March 2024 in the EU & Nov 2025 in the US
  • Xolair (developed by Genentech & Novartis) is used to treat allergic asthma, chronic urticaria & nasal polyps. The company plans to complete the remaining P-III studies of CT-P39 and file for product license in Korea and other countries in 2023

9. Celltrion Healthcare Reports Real-World Results Demonstrated Interchangeability of Rituximab Biosimilar

Date- April 11, 2023

Product: Truxima

  • The retrospective observational study published in Internal and Emergency Medicine evaluating patient outcomes after switching from reference rituximab to a biosimilar version (Truxima), showed that transitioning b/w products were safe for patients with no impact on the occurrence of AEs
  • No significant differences were seen b/w 2 treatment groups, and no treatment-emergent IRRs of grade 3 or higher were reported in either treatment group. Infections were observed in 33.9% of the biosimilar group vs 35.0% in the rituximab
  • Rituximab is used to treat AAV, RA, and SLE on the label, systemic sclerosis, inflammatory myopathies, Sjogren syndrome, and IgG4-related disease off label

10. Teva's Partner Alvotech Receives a Complete Response Letter on the BLA of AVT02 (biosimilar, adalimumab)

Date- April 13, 2023

Product: AVT02 (biosimilar, adalimumab)

  • The US FDA has issued a CRL to its partner Alvotech for the BLA of AVT02, a high-concentration biosimilar candidate for Humira (adalimumab)
  • The application could not currently be approved due to issues with Alvotech's manufacturing facility that need to be satisfactorily resolved. To determine the next steps., additional review of the details, following the recent FDA re-inspection and CRL are being assessed
  • The US FDA is still reviewing Alvotech's second BLA for AVT02 incl. data to support approval as a biosimilar & additional information supporting interchangeability designation & BsUFA goal date is expected on June 2023. AVT02 is currently marketed in 16 countries in the EU & Canada

11. Intas Pharmaceuticals Reports Real-World Study Results of Razumab (biosimilar, ranibizumab) for Polypoidal Choroidal Vasculopathy

Date- April 15, 2023

Product: Razumab (biosimilar, ranibizumab)

  • The real-world study in India evaluating Razumab vs Lucentis, showed that Razumab had comparable visual acuity outcomes to Lucentis with an adequate safety profile, changes in BCVA, SRF, IRF, SRF height, SFCT & the safety profiles were assessed at 12/24/52wk.
  • Improvement from baseline in BCVA was significant in the reference product at all visits (12/24/52wk.) with a greater mean no. of inj. whereas improvement did not reach statistical significance in the biosimilar group until 52wks.
  • SRF height & proportions of eyes with SRF was similar b/w groups at baseline and all visits with no significant changes in SFCT and the proportion of eyes with IRF & SRF in either group but reduction in SRF height in both groups at 52wk., reference product had less SFCT over biosimilar at 52wk. no other ocular or systemic adverse effects were observed

12. Celltrion Launches Vegzelma (biosimilar, bevacizumab) for Multiple Cancers in the US

Date- April 17, 2023

Product: Vegzelma (biosimilar, bevacizumab)

  • Celltrion reported commercial availability of Vegzelma, a biosimilar referencing Avastin for the treatment of multiple cancers incl. metastatic colorectal & breast cancer
  • The company will be responsible for US marketing as part of its plans to strengthen its presence in the world's biggest pharmaceutical market. Vegzelma is the first Celltrion biosimilar to launch in the US
  • Vegzelma was approved in the US in Sept 2022 as monotx. or in combination with other agents for multiple cancers & was also approved and/or launched in multiple other countries incl. Canada, Japan & the EU. The company also plans to release its new products & biosimilars, incl. Yuflyma and Remsima SC in the US in the coming future

13.Dr. Reddy’s Laboratories Reports Real-World Study Results of Redditux (biosimilar, rituximab) for Diffuse Large B-Cell Lymphoma

Date- April 18, 2023

Product: Redditux (biosimilar, rituximab)

  • Dr. Reddy’s Laboratories highlighted the real-world study in Turkey evaluating Redditux + CHOP vs Rituxan + CHOP in patients with hematological malignancies incl. DLBCL
  • The results showed that the patients treated with rituximab biosimilar had similar OS over Rituxan, ORRs (86% vs 84%); CR (72.5% vs 82%); PR (13.5% vs 2%); patients had the refractory disease (14% vs 15.6%), respectively
  • The 24mos. PFS rates (74% vs 85%) while 45.5% vs 63% for patients with high revised International Prognostic Index scores, CNS relapse was higher in the biosimilar group (10% vs 1.83%) with bone involvement. Patients experiencing grade 2 infusion reactions (20%) & no serious AEs resulted in cessation of rituximab therapy

14. Samsung Bioepis Reports P-III Study Results of SB11 (biosimilar, ranibizumab) for Neovascular Age-Related Macular Degeneration

Date- April 21, 2023

Product: SB11 (biosimilar, ranibizumab)

  • The long-term follow-up results from the P-III equivalence study evaluating SB11 vs Lucentis which showed the similarity in efficacy EPs reported early on was maintained through 52wks.
  • The results also showed improvements in visual outcomes remained stable through 52wks. The safety profile was consistent with the known profile with no new safety concerns, 2% vs 1.1% experienced ocular TEAEs leading to the discontinuation of the study treatment
  • Cumulative incidence of ADAs over the 52wk. study was 4.2% vs 5.5%, no significant differences in the incidences of ADAs or neutralizing Ab b/w groups were reported, PK analysis of 54 patients showed comparable mean serum concentrations and PK profiles

15. Samsung Bioepis Presents 52 Weeks P-III Study Results of SB15, Proposed biosimilar to Eylea (aflibercept) for Neovascular Age-Related Macular Degeneration at ARVO 2023

Date- April 25, 2023

Product: SB15

  • The company highlighted the 1yr. results from the P-III study evaluating SB15 vs aflibercept. Additionally, 32wk. interim results from the same study were previously presented at AAO 2022
  • SB15 showed comparable efficacy, safety, immunogenicity & PK profiles to reference aflibercept @~56wks. along with improvements in BCVA & anatomic outcomes. Switching from aflibercept to SB15 did not reveal any treatment-emergent issues i.e., loss of efficacy, increased AEs or immunogenicity,
  • New analytical data on similarity b/w SB15 and the reference product were also presented where SB15 showed high similarity to AFL with respect to structural, physicochemical, and biological properties

Related Post: Insights+ Key Biosimilars Events of March 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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