Insights+ Key Biosimilars Events of July 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 July, Samsung Bioepis reported P-III equivalence study results of SB11 (biosimilar, ranibizumab) for neovascular AMD. Aurobindo Pharma subsidiary CuraTeQ signed an exclusive license agreement with BioFactura to commercialize BFI-751, a proposed biosimilar to Stelara. Our team at PharmaShots has summarized 16 key events of the biosimilar space of July 2023
1. Sandoz to Launch Hyrimoz High-Concentration Formulation Biosimilar in the US
Date- July 01, 2023
Product: Hyrimoz
- The company will launch citrate-free high-concentration formulation (HCF) of biosimilar Hyrimoz (adalimumab-adaz) injection in the US
- Hyrimoz HCF (100mg/mL) is approved for indications that are no longer covered exclusively for the reference medicine incl. RA, PsA, CD, JIA, AS, UC, PsO & hidradenitis suppurativa. It uses the same auto-injector as Hyrimoz 50 mg/mL, the Sensoready pen
- Hyrimoz was approved in the US in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction over the original concentration and can decrease the number of inj. required for people who need at least 80mg/0.8 mL dosing
Date- July 03, 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
3. Organon and Samsung Bioepis Launch Hadlima (biosimilar, adalimumab)
Date- July 03, 2023
Product: Hadlima (biosimilar, adalimumab)
- The companies launched Humira biosimilar Hadlima in the US with a list price i.e., an 85% discount off the reference Humira for patients suffering from chronic autoimmune diseases. Hadlima is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL)
- The companies continue to work with partners and other stakeholders to provide wider availability in the US & offer a new comprehensive patient support program “HADLIMA For You” that features educational resources incl. a co-pay program and dedicated nurse coaches
- Samsung Bioepis’s adalimumab biosimilar (marketed under different brand names outside of the US) has been available in 24 markets globally
4. Coherus Launches Yusimry (biosimilar, adalimumab) in the US at 85% Discount
Date- July 03, 2023
Product: Yusimry (biosimilar, adalimumab)
- The company will launch Yusimry, a Humira biosimilar with a list price of $995 per carton (2 x 40 mg/0.8 mL autoinjectors) represents an 85% discount from the originator, currently priced at $6,922 per carton of 2 pens
- Coherus was partnered with the Mark Cuban Cost Plus Drug Company to sell the biosimilar at $569.27 (plus dispensing & shipping fees) and it will be included in the Team Cuban Card prescription benefit program through participating pharmacies
- Coherus’ patient services platform Yusimry Solutions provide improved access, and a fast & seamless experience as patients start or switch to Yusimry which is a tumor necrosis factor blocker that was approved in the US in 2021 to reduce the signs and symptoms of RA, JIA, PsA, AS, CD, UC, PsO & hidradenitis suppurativa
Date- July 04, 2023
Product: Idacio (biosimilar, adalimumab)
- The company reported the commercial availability of citrate-free adalimumab biosimilar Idacio (adalimumab) in the US for use in the treatment of chronic autoimmune diseases. Idacio is available in a self-administered prefilled syringe and a self-administered pre-filled pen
- Idacio, the first immunology biosimilar is indicated for reducing signs and symptoms of RA, juvenile idiopathic arthritis, PsA, ankylosing spondylitis, CD, UC in adults, and PsO
- Additionally, Idacio-branded biosimilar is available in 35+ countries while CMS grants Fresenius Kabi permanent, product-specific Q-Code for Idacio (adalimumab-aacf)
6. Celltrion Launches Yuflyma (biosimilar, adalimumab) in the US
Date- July 04, 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
Date- July 04, 2023
Product: SB11 (biosimilar, ranibizumab)
- The P-III equivalence study evaluates the efficacy, safety, immunogenicity & PK of ranibizumab biosimilar SB11 (0.5mg, IVI) vs reference ranibizumab in a ratio (1:1) in patients aged ≥50yrs. with nAMD
- The results support biosimilarity b/w the treatment, the incidence of ocular TEAEs (32.0% vs 29.7%) & serious ocular TEAEs (2.9% vs 2.3%) seemed comparable with no new safety concerns while PK & immunogenicity profiles were comparable with a 4.2% and 5.5% cumulative incidence of antidrug Abs up to 52wk., baseline and disease characteristics were also comparable
- No clinical differences were seen b/w SB11 and ranibizumab. Primary and secondary efficacy EPs remained similar at all time points up to 52wk.
8. Kashiv Biosciences Reports P-I Clinical Study Results of ADL018 (biosimilar, omalizumab)
Date- July 05, 2023
Product: ADL018 (biosimilar, omalizumab)
- The P-I study has been completed evaluating ADL018, a biosimilar candidate to Xolair, EU-approved omalizumab, or US-licensed omalizumab via SC inj. in healthy volunteers
- The primary objective of the study was to demonstrate PK similarity by evaluating the area under the concentration-time curve from time zero to infinity (AUCinf) and Cmax and compare the safety & tolerability while the secondary objectives were to determine the PD activity & immunogenicity b/w three treatment groups
- The company plans to initiate the patients dosing in the P-III study shortly for CSU. Omalizumab was approved to treat persistent asthma in patients aged ≥6yrs. and chronic rhinosinusitis with nasal polyps in patients aged ≥18yrs.
Date- July 08, 2023
Product: Exemptia (biosimilar, adalimumab)
- The company highlighted the real-world study in India evaluating adalimumab biosimilar Exemptia for 10wks., showed improvements in disease activity through 48wks., significant improvements at 4wk. were seen in pain VAS, patient global assessment, Health Assessment Questionnaire, ESR & CRP
- 82% achieved ASAS 20 at 12wks. and ASAS 40 (70%), 50% achieved an ASAS 20 response at each time point (4, 8, 12, 24, 36, and 48wks., and 42% demonstrated continued improvement in ASAS 20 index from 12-36wks., improvements in efficacy EPs at 12wk.
- None of the patients reported serious AEs, and no patients developed symptoms of TB, 10 with mild AEs, 11 withdrew from the study due to a poor therapeutic response while no patients withdrew due to AEs
Date- July 10, 2023
Product: ENZ110 (biosimilar, romiplostim)
- The company highlighted the study results published in the Indian Journal of Hematology and Blood Transfusion evaluating biosimilar romiplostim ENZ110 vs innovator romiplostim (Nplate) in a ratio (1:1) in patients aged 18-65yrs. with chronic immune thrombocytopenia for 12wks.
- The results showed noninferiority and comparable safety and immunogenicity between biosimilar romiplostim (ENZ110) and innovator romiplostim (Nplate), platelet response of >50 x 109/L was achieved in 85.3% vs 75.0% in per protocol population over 12wks.; 83.8% vs 76.9% in ITT population
- TEAEs (65.4%), AEs were recorded in 66.7% vs 61.5%, rates of patients who have at least 1 AE were similar b/w groups, treatment-emergent anti-drug Ab (5.71% vs 9.09%)
Date- July 11, 2023
Product: BFI-751
- BioFactura will receive license fees of ~$33.5M across different milestones leading to commercialization, and ~43% profit sharing depending on the territory. The collaboration focuses on improving outcomes, QoL, and accessibility, and enhancing the patient experience with high-quality biosimilar medicines
- CuraTeQ to get an exclusive license right to commercialize BFI-751 in all major regulated markets incl. US, EU, UK, Canada, Australia & New Zealand, and other semi-regulated & emerging markets globally, also get the global manufacturing rights which will be produced at CuraTeQ facilities in Hyderabad, India
- CuraTeQ plans to file the biosimilar in India & emerging markets as early as 2024 with regulated market filings in 2026
Date- July 13, 2023
Product: DRL_RI
- The BLA for the proposed biosimilar rituximab DRL_RI has been accepted for review by the US FDA, EMA & MHRA. DRL_RI, a biosimilar of Rituxan/ MabThera (rituximab) was approved for various indications for adult patients with RA, NHL, CLL, pemphigus vulgaris, granulomatosis with polyangiitis & microscopic polyangiitis
- The full set of clinical studies has been completed for the proposed rituximab biosimilar DRL_RI to file in the US, EU & other regions
- Rituximab biosimilar was approved for marketing in India and ~25 emerging markets. Dr. Reddy is currently collaborating with its partner Fresenius Kabi to commercialize the proposed biosimilar of rituximab in the US, planning to commercialize the product in the EU & other geographies
Date- July 17, 2023
Product: DMB-3115
- The EMA has accepted the MAA for DMB-3115, a biosimilar of Stelara. The MAA submission was based on the results of an extensive analytical similarity assessment evaluating DMB-3115 & was also based on the P-III multi-regional clinical trials in patients with PsO
- The 1EPs of the study was the rate of change in PASI for skin symptoms while therapeutic equivalence and safety were confirmed b/w DMB-3115 and Stelara
- Dong-A ST & Meiji Seika Pharma collaborated with Intas in July 2021 where Intas get an exclusive commercialization right globally excl. Korea, Japan & some Asian countries, commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada
14. Sandoz Receives EMA’s CHMP Positive Opinion of Biosimilar Natalizumab for Multiple Sclerosis
Date- July 24, 2023
Product: Natalizumab
- The EMA’s CHMP has adopted a positive opinion regarding marketing authorization for natalizumab, a first-of-a-kind biosimilar for multiple sclerosis. Polpharma Biologics developed biosimilar natalizumab & will be commercialized by its collaboration partner Sandoz
- The opinion was based on evidence from extensive analytical characterization incl. P-I PK/PD study & confirmatory P-III study (Antelope) in RRMS patients. Both studies met their 1EPs & showed similarity of the biosimilar with reference biologic in terms of PK, efficacy, safety, and immunogenicity
- The EC marketing authorization is valid in all EU Member States, as well as EEA countries Iceland, Liechtenstein, Norway & Northern Ireland under the Northern Ireland Protocol
15. Biocon Biologics Receives EMA’s CHMP Positive Opinion of Yesafili (biosimilar, aflibercept)
Date- July 24, 2023
Product: Yesafili (biosimilar, aflibercept)
- The EMA’s CHMP has issued a positive opinion recommending approval of Yesafili, an aflibercept biosimilar. The EC decision on the approval is expected at the end of Sept 2023
- Yesafili is intended for the treatment of neovascular (wet AMD), visual impairment due to macular oedema secondary to RVO, visual impairment due to DME, and myopic CNV. The results showed that Yesafili has comparable quality, safety, and efficacy to Eylea
- Eight biosimilars have been commercialized by Biocon Biologics in emerging & advanced markets incl. the US, EU, Australia, Canada, and Japan. The company also has 20 biosimilar assets across diabetology, oncology, immunology, and other non-communicable diseases
Date- July 27, 2023
Product: BAT1706
- The study showed that a proposed biosimilar BAT1706 & reference bevacizumab (EU/US-sourced Avastin) demonstrate high similarity in terms of physicochemical & functional attributes
- BAT1706 was shown to have an identical amino acid sequence and an indistinguishable higher-order structure over EU/US-bevacizumab. BAT1706 & also exhibited similar post-translational modifications, glycan profiles, and charge variants
- Potency was assessed using a wide range of bioassays and was also shown to be comparable b/w BAT1706 and EU/US-bevacizumab with statistical equivalence for VEGF-A binding and neutralizing activity. Bevacizumab, a VEGF- targeting biologic used to treat multiple cancers, incl. metastatic colorectal cancer
Related Post: Insights+ Key Biosimilars Events of June 2023
