Insights+ Key Biosimilars Events of February 2024
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 patients
- During February, Sandoz received Health Canada’s approval for Jubbonti while Rani Therapeutics reported the results for its RT-111 Capsules. Our team at PharmaShots has summarized 12 key events of the biosimilar space of February 2024
Date: Feb 01, 2024
Product: SB15
Shots:
- Samsung Bioepis entered into a collaborative agreement with Samil Pharmaceuticals to co-commercialize SB15, a biosimilar version for Eylea (aflibercept) for the treatment of wet age-related macular degeneration (wAMD) & diabetic macular edema (DME) across Korea
- Earlier in Jun 2022, both companies had collaborated to jointly commercialize Amelivu, a biosimilar version of Lucentis for the treatment of AMD, DME, DR, mCNV & RVO, across the Korean market
- From Jun 2020 to Mar 2022, Samsung Bioepis conducted a P-III clinical trial for SB15 in patients (n=449) with nAMD across 10 countries incl. the US and Korea
Date: Feb 05, 2024
Product: RT-111 Capsules
Shots:
- The P-I clinical trial evaluates the safety & efficacy of RT-111 in delivering CT-P43 (biosimilar, ustekinumab) in patients with moderate to severe plaque psoriasis, active psoriatic arthritis & IBD
- As per the results, RT-111 delivered CT-P43 in a dose proportional manner with high bioavailability & depicted a higher Cmax & shorter Tmax vs ustekinumab delivered by SC injection
- RT-11 is a RaniPill capsule that contains CT-P43, a biosimilar of Ustekinumab, a human IgG1қ mAb that functions by binding with specificity to the p40 protein subunit used by both the IL-12 & IL-23 cytokines
Date: Feb 09, 2024
Product: Ogivri and Abevmy
Shots:
- Under the terms of the agreement, Sandoz received the exclusive right to commercialize and distribute Ogivri, the biosimilar version of Herceptin & Abevmy, the biosimilar version of Avastin, across Australia for the treatment of various cancer indications
- Additionally, Sandoz AG will be held responsible to distribute Biocon’s biosimilar versions of trastuzumab and bevacizumab across Australia for the next 5yrs.. Earlier, Ogivri & Abevmy were distributed by another pharmaceutical country across Australia
- Herceptin is approved for the treatment of early-stage breast cancer, and Avastin is approved for the treatment of metastatic colorectal cancer (mCRC)
Date: Feb 20, 2024
Product: Jubbonti
Shots:
- Health Canada has approved the Jubbonti subcutaneous injection to treat osteoporosis and increase bone mass. The approval is based on the results of Phase I and Phase III clinical studies results that show Jubbonti has the same safety and risk as the reference medicine (Prolia)
- This human mAb and ligand inhibitor (bone metabolism regulator) is also approved to treat all five indications, just like the reference medicine
- Sandoz continued the expansion of Jubbonti and will be available in the Canadian market in the coming month as a 60 mg/mL solution in a single-use prefilled syringe
Date: Feb 06, 2024
Product: HLX01
Shots:
- The P-III (HLX01-NHL03) clinical trial evaluates the bioequivalent safety & efficacy of HLX01 vs Rituxna (rituximab) in patients with diffuse large B-cell lymphoma (DLBCL). The 1EPs of the study include OS & PFS
- As of the cut-off date (Apr 28, 2022) from the R-CHOP & H-CHOP evaluation, of 316 evaluable patients, 6 planned treatment cycles were completed by 91.8% vs 87.3%. Moreover, the 5yrs. OS rates were 75.4% & 81% & PFS were 75.6% vs 79.6%
- Results for patients with an IPI score of 1 were significantly better than those with a score of 2 (OS: 79.4% vs 76% & PFS: 79% vs 70.4%). Additionally, Rituximab is a mAb indicated for the treatment of DLBCL & other aggressive cancers
Date: Feb 21, 2024
Product: MW032
Shots:
- The results from the P-III trial comparing MW032’s (SC, Q4W, until wk. 49) safety, efficacy & PK vs reference drug (denosumab) to treat patients (n=708), randomized 1:1, with solid tumors having bone metastasis are published in JAMA Oncology
- The 1EP includes percentage change in natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr) from baseline to wk.13 and 2EPs are percentage change from baseline to wks. 5, 13, 25, 37 & 53 of uNTx/uCr & bone-specific alkaline phosphatase (s-BALP) as well as the incidence of SREs
- The study depicted a mean change of −72.0% in uNTx/uCr with MW032 vs −72.7% having an LSM difference of 0.02 and established the biosimilarity b/w MW032 & denosumab
Date: Feb 21, 2024
Product: Udenyca Onbody
Shots:
- The US FDA approved Udenyca Onbody earlier in Dec 2023, as an OBI device to administer Udenyca, a biosimilar of pegfilgrastim. The company has launched Udenyca in the US market for the treatment of patients with non-myeloid malignancies
- Udencya is a leukocyte growth factor indicated to be administered the day after CT to lower the rate of infection caused by febrile neutropenia and increase survival in patients exposed to myelosuppressive doses of radiation
- The Udenyca Onbody is comprised of a five-minute injection time, an indicator, a status light, an auditory signal, and a needle that automatically retracts after the administration
Date: Feb 21, 2024
Product: SB27
Shots:
- The company received the MHLW’s approval to initiate a P-I clinical trial for the bioequivalence evaluation of SB27 as compared to Keytruda (pembrolizumab)
- The P-I clinical trial evaluates the safety, efficacy & immunogenicity of SB27 vs Keytruda in patients with Stage II-IIIA NSCLC following complete resection & adjuvant Platinum-based CT
- Keytruda is a PD-1-blocking antibody approved for the treatment of various indications incl. NSCLC
Date: Feb 22, 2024
Product: SB17
Shots:
- The first study highlights the results from the analytical assessment of the safety & efficacy of SB17 vs Stelara (ustekinumab) which demonstrated SB17 to be biologically similar to Stelara in terms of its physicochemical, structural & biological attributes
- Additionally, the data supports the similarity of SB17 with reference Stelara in terms of the biosimilarity, PK, PD & clinical effect in patients suffering from moderate-to-severe psoriasis
- Samsung Bioepis has recently signed a collaborative agreement with Sandoz to commercialize SB17 across the US, EU, UK, Canada & Switzerland
Date: Feb 23, 2024
Product: CT-P13
Shots:
- The company presented 2yrs. results from the P-III (LIBERTY-CD) & (LIBERTY-UC) trial evaluating the superiority in safety & efficacy of CT-P13 (SC) vs Remicade in patients (n=180 & 237) with moderately to severely active CD & UC
- In the trials, 85.6% & 87% of patients completed the extension phase with clinical remission, clinical response, endoscopic remission, endoscopic response & corticosteroid-free remission maintained at wk.102 vs wk.54
- The company also presented a post hoc analysis evaluating the pattern of endoscopic mucosal healing across intestinal segments in patients enrolled in the P-III (LIBERTY-CD) trial. The results showed a significantly higher rate of endoscopic complete mucosal healing & partial mucosal healing with CT-P13 vs PBO
Date: Feb 23, 2024
Product: Simlandi
Shots:
- The US FDA has approved Simlandi injection for treating adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa & uveitis as well as juvenile idiopathic arthritis & Crohn's Disease
- The approval was based on a series of studies incl. P-I (AVT02-GL-101) trial comparing the PK, safety & tolerability in healthy adults and two P-III (AVT02-GL-301 & AVT02-GL-302) studies comparing the PK, efficacy, safety & immunogenicity of Simlandi vs Humira to treat moderate-to-severe chronic plaque psoriasis
- Teva is responsible for the exclusive commercialization of Simlandi across the US under a strategic collaboration with Alvotech
Date: Feb 29, 2024
Product: CT-P47
Shots:
- The submission was based on the results from the P-III clinical trials evaluating the equivalence & similarity of CT-P47 vs Actemra (tocilizumab) in patients (n=471) with rheumatoid arthritis (RA)
- Moreover, based on these results the company also expects to accelerate its marketing authorization application across Canada & other countries. The company expects to receive approval by the year 2025
- Actemra is an interleukin inhibitor that functions by reducing inflammation through the inhibition of IL-6 protein
Related Post: Insights+ Key Biosimilars Events of January 2024
Tags
Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
