Insights+ Key Biosimilars Events of March 2023
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 the patients
- During the month of March, Biogen launched Byooviz (biosimilar, ranibizumab) for the treatment of retinal disorders in Canada, Coherus received the US FDA’s approval of Udenyca (biosimilar, pegfilgrastim) for febrile neutropenia. Our team at PharmaShots has summarized 16 key events of the biosimilar space of March 2023
Alkem Subsidiary Enzene Biosciences Launches Adalimumab Biosimilar in India
Date- March 01, 2023
Product: Adalimumab Biosimilar
- Enzene Biosciences initiated the commercial supplies of adalimumab biosimilar for treating autoimmune disease i.e., rheumatoid arthritis and ankylosis spondylitis
- This fourth biosimilar help to reduce the cost of RA treatment across India using continuous manufacturing technology. Enzene’s novel platform offers higher productivity compared to traditional manufacturing processes & further reducing costs
- Additionally, Alkem has developed exceptional clinical development capabilities for complex therapies which have enabled us to significantly influence Indian healthcare & plans to expand global access to its platform via its CDMO vertical & Alkem
Date- March 01, 2023
Product: Sintilimab
- The company highlighted the cost-effectiveness analysis from the ORIENT-32 and REFLECT studies evaluating the sintilimab combined with a bevacizumab biosimilar vs lenvatinib for patients with HCC
- Sintilimab + bevacizumab biosimilar is likely to be a cost-effective treatment option & could improve QoL for patients at a higher cost than lenvatinib & yielded an additional 0.493 quality-adjusted life-years (QALYs) at a high cost
- The lower ICER was estimated when the dose of bevacizumab biosimilar decreased from 15mg to 7.5mg/kg in the scenario analysis. Sintilimab + bevacizumab was approved in China in 2021 for 1L treatment of unresectable or metastatic HCC
Biogen Launches Byooviz (biosimilar, ranibizumab) for the Treatment of Retinal Disorders in Canada
Date- March 02, 2023
Product: Byooviz (biosimilar, ranibizumab)
- The company reported the commercial availability of Byooviz (ranibizumab injection), the first biosimilar referencing Lucentis for the treatment of serious eye disorders incl. neovascular (wet) AMD
- Additionally, the availability of Byooviz could enable more patients to access this type of vision-saving therapy as it brings a sustainable and cost-effective anti-VEGF treatment to Canadian vision care
- Byooviz was approved in Canada for the treatment of multiple eye disorders. The company's main goal is to advance the most diverse pipelines in neuroscience, which will revolutionize patient care in a no. of areas with a high unmet need
Date- March 03, 2023
Product: PB006 (biosimilar, natalizumab)
- The P-III study evaluating biosim-NTZ vs Tysabri in a ratio (1:1) in patients with RRMS across 48 centers in 7 countries
- The results showed that biosim-NTZ matches the efficacy, safety, and immunogenicity of ref-NTZ in patients with RRMS & no clinically relevant differences were found b/w the proposed biosimilar and the reference drug, according to the study published in JAMA Neurology, the model-based mean difference in the cumulative no. of new active lesions was similar b/w treatment groups @24wk.
- There were no new or elevated risks associated with switching to biosim-NTZ, and the overall AE profile for patients switching from ref-NTZ to biosim-NTZ was similar to that of patients continuing ref-NTZ treatment
MiGenTra Reports the First Patient Dosing of Adessia (biosimilar, adalimumab) in Germany
Date- March 06, 2023
Product: Adessia (biosimilar, adalimumab)
- The first participant has been dosed in the P-I clinical trial of adalimumab biosimilar candidate in 154 healthy male and female participants
- The study focuses to compare the PK, safety, immunogenicity, and tolerability of adalimumab biosimilar Adessia, and its reference Humira. The results are expected at the end of 2023
- Additionally, MiGenTra and Minapharm will be sharing responsibilities to file, launch and commercialize Adessia in Africa and the Middle East. Minapharm previously announced on February 2023 that the Paul-Ehrlich Institute had given an unconditional approval to the P-I trial
Date- March 07, 2023
Product: Udenyca (biosimilar, pegfilgrastim)
- The US FDA has approved a new single-dose prefilled autoinjector presentation of Udenyca, a biosimilar to Neulasta for the treatment and prevention of febrile neutropenia. Udenyca is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation
- The approval was based on the comprehensive analytical data package, along with a PK, PD, and immunogenicity study. The single-dose prefilled autoinjector is expected to be available in Q2’23 and can be used for both in-clinic and at-home administration
- The open-label, crossover study showed PK & PD bioequivalence of Udenyca when administered by the on-body injector through a prefilled syringe
Date- March 10, 2023
Product: FYB201 (biosimilar, ranibizumab)
- The 48wk. P-III trial (COLUMBUS-AMD) evaluating FYB201 vs reference ranibizumab in 712 patients which showed a comparable safety & efficacy b/w biosimilar FYB201 vs reference ranibizumab & was published in Ophthalmology
- BCVA improvement in both groups with a mean improvement of +5.1 ETDRS vs +5.6 letters @8wk. while the mean BCVA improved in the US-relevant population with a mean change of +5.1 vs +5.6. The same trends & similarities were observed in the EU-relevant patient population
- The frequency & type of ocular AEs were comparable with no clinically relevant differences, were well tolerated with no safety concerns & the safety profile of FYB201 was consistent with reference ranibizumab, AEs linked to the IVT inj. procedure (21.4% vs 27.6%)
Celltrion Reports Result of CT-P10 (biosimilar, rituximab) for the Treatment of Rheumatic Disease
Date- March 11, 2023
Product: CT-P10 (biosimilar, rituximab)
- The study published in Springer evaluating CT-P10 vs rituximab in 128 patients with rheumatic disease in a real-world setting. The descriptive study was conducted in the University Hospitals Rheumatology Outpatient Clinic and approved by the University Clinical Studies Ethics Committee
- Additionally, 40.6% switched to CT-P10, and 35.5% continued rituximab treatment. The results showed no differences in AEs incl. infusion-related reactions, infections, and hypogammaglobulinemia among patients who received rituximab and the biosimilar CT-P10
- CT-P10 provides a safe treatment alternative in patients who require rituximab therapy. CT-P10 is the first biosimilar of rituximab approved in the EU
Samsung Bioepis Reports P-I Study Results of SB17, a Proposed Biosimilar to Stelara
Date- March 17, 2023
Product: SB17
- The P-I study evaluating SB17 (45mg) vs Stelara (US & EU sourced) via SC inj. in a ratio (1:1:1) in 201 patients. The primary objective was to demonstrate PK similarity by assessing area under AUCinf and Cmax & secondary objectives was to investigate and compare the safety, tolerability, and immunogenicity b/w three treatment groups
- The study results showed PK equivalence and comparable safety, tolerability, and immunogenicity profiles b/w SB17 and reference ustekinumab. The results will be presented at AAD 2023
- Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, hematology, and endocrinology
Date- March 17, 2023
Product: AVT04
- The company highlighted the posters at AAD 2023 on the two clinical studies i.e., (AVT04-GL-101) & (AVT04-GL-301) that support the clinical comparability and biosimilarity of Alvotech’s ATV04 and the reference Stelara
- Poster Titled: “Assessment of Bioequivalence Between Candidate Biosimilar AVT04 and Reference Ustekinumab” & “Assessment of Therapeutic Equivalence Between Candidate Biosimilar ATV04 and Reference Ustekinumab”
- The confirmatory (AVT04-GL-301) study had met its 1EPs which showed therapeutic equivalence b/w Alvotech’s biosimilar candidate and the reference ustekinumab. The marketing applications for AVT04 have been submitted in major markets incl. US and EU
Date- March 20, 2023
Product: COYA 302
- Dr. Reddy’s will receive up front & an additional fee upon achievement of development milestones along with royalties on net sales of COYA 302 within its licensed territory
- The agreement allows Coya's COYA 301 to be licensed to Dr. Reddy's to permit the commercialization of COYA 302 in territories not otherwise granted to Coya. Similar to what Coya owes Dr. Reddy's, Coya will receive royalties on net sales in their territories
- Coya holds an exclusive right to develop & commercialize COYA 302 across multiple neurodegenerative diseases in multiple territories, incl. North & South America, the EU, UK & Japan while Dr. Reddy’s holds an exclusive right for COYA 302 in areas outside of Coya’s territory. Coya plans to file an IND for COYA 302 in H2’23 & will initiate the P-Ib/II trial in ALS shortly
Date- March 21, 2023
Product:
- The (PERFUSE) study evaluating the persistence, effectiveness & safety of Flixabi in 569 patients with Crohn’s disease and 168 patients with ulcerative colitis at specialist sites across France
- For CD & UC, the results showed persistence (89% & 78.5%) at 12mos. who were naïve to infliximab; 94% & 92.8% in the infliximab reference group; 100% & 100% in the infliximab multi-switch group, disease activity among infliximab naive patients declined from baseline to 12mos.
- The proportions of patients in remission at baseline, 6 & 12mos. remained unchanged in the UC cohort, and were comparable or higher in the CD cohort, no immunogenicity or safety signals were seen. Infliximab biosimilar was safe & efficacious for IBD
Sandoz’s Hyrimoz (biosimilar, adalimumab) Receives the US FDA's Approval for Multiple Indications
Date- March 21, 2023
Product: Hyrimoz (biosimilar, adalimumab)
- The US FDA has approved Hyrimoz (adalimumab-adaz) high-concentration formulation, a biosimilar to Humira (adalimumab) for 7 indications incl. RA, JIA, PsA, AS, CD, UC and PsO. The biosimilar product is expected to be available on July 1, 2023
- The approval was based on the results from a P-I PK bridging study evaluating adalimumab (50mg/mL) vs citrate-free HCF (100mg/mL) which showed that the study met all of the primary objectives confirming similar safety, immunogenicity, and PK of Hyrimoz 50mg/mL and the high-concentration formulation
- Sandoz continues to expand patient access to much-needed medications, increase healthcare savings, and fuel innovation through increased competition
Date- March 22, 2023
Product: Amgevita (biosimilar, adalimumab)
- The multi-center UK cohort evaluate the clinical efficacy of Amgevita vs Humira in 102 patients aged 2–75yrs. from tertiary uveitis clinics in 3 centers, after institution-mandated switching was implemented
- The results showed that Amgevita was found to be safe and effective for non-infectious uveitis with non-inferiority to originator adalimumab. Following the switch, rates of uveitis flare were not significantly different, rates of elevated intraocular pressure were decreased and dosing of oral and intra-ocular steroids was stable, 24% requested to return to Humira due to side effects incl. inj. site reactions in the pediatric population
- In addition, 4 patients were switched to a different agent after being identified as having treatment failure on adalimumab
Date:- Mar 23, 2023
- The real-world study in Denmark supports the use of switching from the infliximab biosimilar CT-P13 to GP1111 in patients with RA, PsA, and AxSpA. The results showed that 1171 out of 1605 patients were originator-naïve, retention rates @1yr. were 83% for the originator-naïve and 92% for the originator-experienced, respectively
- Higher retention of GP1111 therapy in originator-experienced and in patients with low disease activity suggesting outcomes be affected by patient-related rather than drug-related factors, changes in disease activity pre-switch and post-switch were close to zero
- In the originator-naïve group, objective disease markers were higher and fewer patients were in remission, no significant difference in AxSpA was reported while switching from CT-P13 to GP1111 was effective and safe
mAbxience Reports P-I Study Results of Bevacizumab Biosimilars MB02-SP and MB02-DM
Date- March 23, 2023
Product: MB02-SP and MB02-DM
- The P-I study evaluates a single 1mg/kg IV dose of MB02-SP & MB02-DM vs bevacizumab in a ratio (1:1:1) in 114 healthy male patients aged 18 & 55yrs. for a follow-up period of 100 dayss
- The results showed similar PK, safety, immunogenicity, & bioequivalence over reference bevacizumab, based on the study published in Pharmacology Research and Perspectives, treatment-induced anti-drug Abs incidence was 21.6% & 33.3% in MB02-SP & MB02-DM group vs 23.7% in bevacizumab with no incidence of treatment-induced neutralizing anti-drug Ab
- MB02 is a bevacizumab biosimilar that has received approval from the US FDA & EMA which previously showed bioequivalence to reference bevacizumab in 3 PK studies in healthy patients
Related Post: Insights+ Key Biosimilars Events of February 2023
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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.
