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 August, Formycon reported P-III (VESPUCCI) trial results of FYB202 (biosimilar, ustekinumab) for the treatment of Psoriasis Vulgaris, Alvotech reported the initiation of confirmatory (AVT03-GL-C01) study for AVT03, a proposed biosimilar to Prolia and Xgeva to treat osteoporosis. Our team at PharmaShots has summarized 12 key events of the biosimilar space of August 2022
1. AryoGen Pharmed Reports P-III Trial Results of Denosumab Biosimilar Demonstrates Noninferiority to Prolia for Postmenopausal Osteoporosis
Published: August 01, 2022
Product: Denosumab Biosimilar
The P-III trial evaluates Arylia vs Prolia in 190 postmenopausal women aged 45 & 75yrs. with osteoporosis across 12 centers in Iran. At 0, 6 & 12mos., patients were given a 60mg, SC of the biosimilar or original drug & then monitored until 18mos.
The results showed a similar efficacy & safety of Arylia along with noninferiority to reference Prolia, the percent changes in BMD at lumbar spine/total hip/femoral neck in the biosimilar group were 5.91/2.32/1.91 over 5.52/2.28/1.50 in the reference Prolia
Reduction in the bone formation markers BSAP, OC, and P1NP & no new vertebral fractures were observed, reduction in bone resorption markers serum CTX and serum NTX over 18mos., AEs were reported in 78% vs 64%
2. Fresenius Kabi Reports the US FDA Acceptance of BLA for Review of MSB11456 (biosimilar, tocilizumab) to Treat Autoimmune Diseases
Published: August 01, 2022
Product: MSB11456 (biosimilar, tocilizumab)
The US FDA has accepted the 351(k) BLA for review of MSB11456, a biosimilar tocilizumab
The submission was based on comprehensive clinical data of MSB11456 as both SC (prefilled syringe & autoinjector) and IV administrations to provide a comprehensive offering for patients with tocilizumab. The results showed a similar PK, efficacy, safety, tolerability & immunogenicity to tocilizumab with/out the switch from patients with tocilizumab to MSB11456
The company focus to develop accessible treatment options for patient globally & continues to expand its biosimilar portfolio across autoimmune diseases & oncology. Fresenius Kabi’s adalimumab biosimilar Idacio has been commercialized in 34+ countries globally
3. Coherus’ Cimerli (biosimilar, ranibizumab) Receives the US FDA’s Approval as a First Interchangeable Biosimilar for the Treatment of Retinal Disease
Published: August 03, 2022
Product: Cimerli (biosimilar, ranibizumab)
The US FDA has approved Cimerli as 1st interchangeable biosimilar to Lucentis for 5 indications incl. wet AMD, Macular Edema following RVO, DME, DR, and mCNV. Cimerli is expected to be available in early October 2022 in both 0.3 & 0.5mg dosages
The approval was based on analytical, preclinical & clinical programs incl. the (COLUMBUS-AMD) study to evaluate Cimerli vs Lucentis. The trial met its 1EPs of change from baseline in BCVA @8wk. & 2EPs included change from baseline in BCVA & FCB retinal thickness @48wks. & showed a clinical equivalence b/w Cimerli & Lucentis with a comparable safety & immunogenicity profile
Cimerli marks the 3rd US FDA-approved product interchangeable with Lucentis for all approved indications
4. Viatris and Sandoz Report Results of Hulio and Hyrimoz (biosimilar, adalimumab) for the Treatment of Inflammatory Bowel Disease
Published: August 11, 2022
Product: Hulio and Hyrimoz (biosimilar, adalimumab)
The study evaluates Viatris’ Hulio & Sandoz’s Hyrimoz in 34 patients with CD and 16 with UC
The results showed that adalimumab biosimilars, Hulio & Hyrimoz were found to be safe & effective for IBD. In CD & UC patients, 73.5% & 18.8% patients achieved remission, 11.8% & 43.8% had PR after 12wks., 11.8% & 25% had no response, and 1 & 2 discontinued therapy due to allergic reaction. Median CDAI & MSS value prior to therapy was 216.0 & 8.0 which decreased to 110.0 & 4.0 after 12wks. of treatment
The results were published in Plos One. Adalimumab biosimilars were less effective than an infliximab biosimilar while patients treated with infliximab biosimilar Inflectra achieved remission (50% & 40.9%) after 14wk. with PR in 50.0% & 54.5% in the CD & UC
5. Samsung Bioepis Reports P-I Study Results of SB12, a Proposed Biosimilar to Soliris (eculizumab) for Paroxysmal Nocturnal Hemoglobinuria
Published: August 13, 2022
Product: SB12
The P-I study evaluates the PK, PD, safety, and immunogenicity of SB12 (300mg, IV) vs Soliris in 240 healthy adult patients with PNH
The results showed PK bioequivalence and similar PD, safety, and immunogenicity profiles of SB12 vs reference eculizumab, 90% CIs of the geometric least squares means ratios of the PK EPs were fully contained within the pre-defined bioequivalence margin of 80-125%
In the SB12/EU & US reference eculizumab, 68.8% experienced TEAEs (70.0%/65.0%/71.3%); ADAs were detected in (2.5%/1.3%/0%) with no neutralizing Abs in ADA+ patients. Eculizumab can reduce the risk of hemolysis and thrombosis in PNH, atypical HUS, generalized MG & NMO spectrum disorder
6. Formycon Reports P-III (VESPUCCI) Trial Results of FYB202 (biosimilar, ustekinumab) for the Treatment of Psoriasis Vulgaris
Published: August 16, 2022
Product: FYB202 (biosimilar, ustekinumab)
The company reported the preliminary efficacy & safety data from the P-III (VESPUCCI) trial to evaluate FYB202 vs Stelara in patients with mod. to sev. psoriasis vulgaris (PsO)
The trial met the primary efficacy EPs, which showed a comparable efficacy b/w FYB202 & the reference Stelara, and no clinical differences in safety & immunogenicity were observed. The 1EPs of the study also measured the percent improvement of the PASI @12wks. from baseline
Stelara has been used to treat multiple severe inflammatory conditions incl. mod. to sev. psoriasis & psoriatic arthritis. Additionally, Formycon had acquired 100% of the rights to FYB202 from ATHOS KG
7. Samsung Bioepis and Organon’s Hadlima (biosimilar, adalimumab) Receive the US FDA’s Approval for Chronic Autoimmune Diseases
Published: August 17, 2022
Product: Hadlima (biosimilar, adalimumab)
The US FDA has approved Hadlima (biosimilar, adalimumab) for patients suffering from chronic, autoimmune diseases. Hadlima is a citrate-free, high-concentration (100 mg/mL) formulation of Hadlima which will be available in pre-filled syringe and autoinjector options
The approval was based on clinical data from a single-dose study to evaluate the PK, safety, tolerability, and immunogenicity of two formulations of Hadlima (100mg/mL vs 50mg/mL) in 88 healthy volunteers
Hadlima is expected to be available in the US in 2023. Hadlima has also approved in the US as a low-concentration (50mg/mL) formulation in July 2019 and outside the US in multiple markets globally under different brand names
8. Celltrion Healthcare’s Vegzelma (biosimilar, bevacizumab) Receives the EC’s Approval for the Treatment of Cancers
Published: August 18, 2022
Product: Vegzelma (biosimilar, bevacizumab)
The EC has approved Vegzelma, biosimilar bevacizumab referencing EU-approved Avastin for the treatment of metastatic breast cancer, NSCLC, advanced or metastatic RCC, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer
The approval was based on the totality of the evidence, incl. the P-III trial for metastatic or recurrent non-sq. NSCLC. The results showed that Vegzelma was highly similar to the reference product in terms of efficacy, safety, and PK
The company has filed for regulatory approval of Vegzelma with the US FDA in Sept 2021 with expected approval in Q3’22. Additionally, the EU patients get a new, safe, and effective treatment option at an affordable price
9. Lupin Entered into an Exclusive License Agreement with I’rom for Denosumab Biosimilar in Japan
Published: August 25, 2022
Product: Denosumab Biosimilar
Lupin will receive multiple milestones fees payments & I’rom will be responsible to conduct clinical trials, registering, distributing, and marketing biosimilar Denosumab in Japan under collaboration with Lupin
I’rom will exclusively commercialize the product in Japan, upon the successful completion of the clinical trial and receipt of marketing authorization from PMDA
Denosumab is currently available under two brands i.e., Pralia and Ranmark & is indicated for the treatment of postmenopausal women with osteoporosis who are at a high risk of fracture and the prevention of skeletal-related events in patients with solid tumor bone metastases
10. Alvotech Reports the Initiation of Confirmatory (AVT03-GL-C01) Study for AVT03, a Proposed Biosimilar to Prolia and Xgeva to Treat Osteoporosis
Published: August 26, 2022
Product: AVT03
The company initiated a confirmatory (AVT03-GL-C01) study to evaluate AVT03 vs Prolia and Xgeva in ~476 volunteers, postmenopausal women aged ≥50yrs. with osteoporosis. After 18mos. from the initial dose, all patients will have a follow-up visit to conclude the study
The study’s objective is to evaluate the clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, PK & change from baseline in markers for BMD. The results will be used to support additional indications for AVT03 to Xgeva based on extrapolation
Alvotech’s current biosimilars portfolio focuses on autoimmune disease, eye disorders, bone disease, respiratory disease, and cancer
11. Teva’s Ranivisio (biosimilar, ranibizumab) Receives EC’s Marketing Authorization for Retinal Diseases
Published: August 29, 2022
Product: Ranivisio (biosimilar, ranibizumab)
The EC has granted the marketing authorization for Ranivisio, a biosimilar to Lucentis for adults across 5 indications incl. AMD, visual impairment due to macular oedema secondary to RVO, visual impairment resulting from DME, PDR, and CNV
The P-III (COLUMBUS-AMD) study showed that ranibizumab was shown to be highly similar to its reference ranibizumab in terms of clinical efficacy, ocular and systemic safety for AMD and other ophthalmology indications
Teva & Bioeq AG collaborated for the exclusive commercialization of ranibizumab and the product is expected to be available in the EU over the coming year while the treatment is already available in the UK under the tradename Ongavia
12. Lannett Reports the Completion of Patient Dosing in Pivotal Clinical Trial for Biosimilar Insulin Glargine
Published: August 31, 2022
Product: Biosimilar Insulin Glargine
The company has completed the patient dosing in the PK and PD study of biosimilar insulin glargine in the healthy volunteer. The biosimilar is being co-developed with its strategic alliance partners within HEC
Additonally, no serious AEs were reported & the further results are expected to be available at the end of 2022
The company will file the BLA for a biosimilar and interchangeable insulin glargine to Sanofi’s Lantus Solostar in 2023 & the product is expected to be available in H1’24
Related Post: Insights+ Key Biosimilars Events of July 2022
