Insights+ Key Biosimilars Events of January 2022
- 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 January, Innovent and Eli Lilly presented results of the P-Ib study of Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) for advanced hepatocellular carcinoma at ASCO GI 2022, Biogen entered into an agreement with Samsung Biologics to sell an equity stake in biosimilar joint venture for ~$2.3B. Our team at PharmaShots has summarized 12 key events of the biosimilar space of January 2022
Published: Jan 03, 2022
Product: Abevmy (biosimilar, bevacizumab)
- The companies reported that the proposed biosimilar MYL-1402O met predefined criteria for bio similarity to Avastin in a P-III trial in patients with stage IV non sq. NSCLC
- The study evaluated the efficacy, safety, and immunogenicity of MYL-1402O vs Avastin + CP CT in 671 patients with stage IV non sq. NSCLC for up to 18wks. (6 cycles), followed by monothx. with the reference drug or the biosimilar for up to 24wks.
- The study showed that the results were comparable between groups including PFS, OS, DCR & DOR; mPFS (7.6mos. vs 9.0mos); patient-reported at least 1 TEAEs (92.8% vs 92.4%)
Published: Jan 05, 2022
Product: PDA10, a Proposed Epoetin Alfa Biosimilar
- The 40wks. comparative study of PDA10, a proposed epoetin alfa biosimilar & the reference Epogen showed comparable efficacy & safety in renal anemia in patients on hemodialysis. The study was conducted in multiple sites across Malaysia and Korea
- The primary efficacy EPs were similar i.e., change in Hb, weekly dose, or safety parameters b/w groups & 2EPs were also comparable b/w groups included change in hematocrit, patients with Hb levels within or out of the target range of 10-12 g/dL {111 (81.62%) vs 108 (90.0%)}, safety and immunogenicity
- Additionally, no anti-epoetin Abs were identified in either group at baseline or in the treatment phase, no differences in patients who experienced TEAEs
Published: Jan 05, 2022
Product: SB5 (biosimilar, adalimumab)
- The US FDA has accepted the sBLA for a citrate-free, high-concentration (100 mg/mL) formulation of SB5, a biosimilar referencing Humira (adalimumab). SB5 will be commercialized in the US by Organon & is expected to launch in the US on July 1, 2023
- The sBLA was based on the clinical data from a single-dose study to evaluate the PK, safety, tolerability, and immunogenicity of SB5 (100 mg/mL vs 50 mg/mL) in healthy volunteers
- In July 2019, SB5 has approved in the US under the brand name Hadlima as a low-concentration (50 mg/mL) formulation. Additionally, the low & high concentration forms of the reference product are marketed in the US
Published: Jan 10, 2022
Product: Simlandi (biosimilar, adalimumab)
- JAMP Pharma has received the marketing authorization from Health Canada for a high-concentration biosimilar to Humira (adalimumab)
- Upon the exclusive commercialization agreement with JAMP Pharma, AVT02 (100 mg/mL) will be marketed as Simlandi in Canada & will provide Canadians access to a biosimilar that is also used across both EU and the US
- Simlandi is a high-concentration, citrate-free biosimilar to Humira & is used to treat inflammatory conditions. Additionally, JAMP Pharma’s commercial infrastructure and expertise will allow Canadian patients to benefit from safe and effective biosimilars along with JAMP Care patient support program
Orion Corporation Expands Biosimilar Distribution Agreement with CuraTeQ Biologics in EU
Published: Jan 11, 2022
Product: N/A
- Orion to get right to commercialize CuraTeQ’s biosimilars in the Nordics, the Baltics, Austria, Hungary, and Slovenia. The products are currently in development or regulatory phases & are expected to be launched in Orion territories in 2023–2026, based on the achievement of the development and regulatory approvals
- The agreement will support Orion’s position in the Nordics and Baltics & helps to expand the accessibility of CuraTeQ’s biosimilar products in selected markets of the EU
- In 2020, the companies have entered into a license agreement, granting marketing and distribution rights for CuraTeQ's biosimilar products under development in the Nordic states, Austria, Hungary & Slovenia
Published: Jan 17, 2022
Product: N/A
- The study evaluated PK/PD parameters in 42 healthy male participants aged 18-55yrs. and were randomized to single doses of the reference product and the biosimilar
- Insulin-R demonstrated PK/PD equivalence to Humulin-R in the study & both were well tolerated. The PK 1EPs were AUC ins and Cmax within the predefined equivalence margins of 80% -125%. For PD, 1EPs were AUC GIR and GIRmax & showed 90% CIs
- The study also showed the PK 2Eps & all PD 2EPs also met the equivalence criteria, no SAEs were reported with no differences in the safety profile. The proposed biosimilar showed similarity in structure and function in physicochemical analyses and nonclinical studies
Published: Jan 19, 2022
Product: BI 695502 (biosimilar, bevacizumab)
- The P-III trial evaluates the safety, efficacy, immunogenicity, and PK of BI 695502 vs bevacizumab RP (Avastin) in patients with recurrent or metastatic NSCLC
- The results showed an ORR (54% vs 63.1%) @18wks. & showed 90% CI for the primary efficacy, patients had ECOG PS of 1 (63.0% vs 60.4%) & more patients had brain lesions (6.6% vs 3.7%), m-PFS (8.3mos. vs 9.0mos.), m-OS (15.6mos. vs 19.5), Plasma concentrations were higher in the bevacizumab RP group
- Additionally, similar efficacy and toxicity in clinical studies of other bevacizumab biosimilars over bevacizumab RP while two biosimilars i.e., Pfizer’s Zirabev and Amgen’s Mvasi have been approved for unresectable, LA NSCLC and recurrent or metastatic nonsq. NSCLC
Lannett Receives the US FDA’s IND Clearance of Biosimilar Insulin Glargine
Published: Jan 21, 2022
Product: Biosimilar Insulin Glargine
- The US FDA has completed the safety review of the IND application for biosimilar insulin glargine. The FDA has stated that the company will proceed with the clinical trial which is expected to start in Mar 20222 across South Africa and be completed by early 2023
- The trial will be conducted using the proposed final to-be-marketed formulation of the Lannett/HEC biosimilar insulin glargine while the company have received the regulatory clearances in the US and South Africa to conduct the study
- The company will initiate the doing of patients in Q1’22 & will file the BLA in early 2023 if the trial is successful. The product is expected to be launched by early 2024 if approved
Published: Jan 24, 2022
Product: Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab)
- The P-Ib study included dose-escalation & expansion stages evaluates sintilimab (200mg) + bevacizumab biosimilar in 50 patients with LA or metastatic HCC
- The results showed the 34% ORR (17/50) & (31% & 38%) for 7.5/15mg/kg (low/high-dose), 78% DCR (39/50), PFS (10.5mos.), m-OS (20.2mos.). In biomarker analysis, patients with a high level of CD137 ≥ 31.8 pg/mL have longer PFS with m-PFS (14.2mos. vs 4.1mos.), mOS (NR vs 15.6mos.) & TiME analysis showed that the high density of M1 macrophages in the stroma was related to higher efficacy, longer PFS & OS
- The safety profile was consistent with previously reported studies of sintilimab & bevacizumab biosimilar with no new safety signals
Published: Jan 26, 2022
Product: SB5 (biosimilar, adalimumab)
- The 2 new studies to evaluate adalimumab biosimilar SB5 for IBD & non-anterior uveitis associated with BS
- In a real-world study for IBD, 83.1% of patients switched from the reference product to biosimilar SB5. In the retrospective study on BS-associated uveitis, 8 patients with SB5 experienced complete resolution of inflammation @16mos.
- In the start & switch cohort, 137 patients (77.8%) & 213 patients (84.6%) remained on the biosimilar after 26wks, 65 (60.3%) & 163 (70.8%) were still being treated with SB5 @52wks. At a median follow-up of 18.3mos. & 13.7mos., 81 (36%) & 90 (35.2%) patients discontinued biosimilar treatment while 24 & 46 due to AES & 26 & 37 due to secondary loss of response
Published: Jan 31, 2022
Product: Yuflyma (biosimilar, adalimumab)
- Health Canada granted a notice of compliance for Yuflyma & the approval was based on the results of analytical, preclinical/clinical studies evaluating Yuflyma vs Humira (adalimumab) in patients with multiple chronic inflammatory diseases
- The results showed that Yuflyma is comparable to Humira (adalimumab) in terms of safety, efficacy, PK/PD, and immunogenicity for ~24wks. and 1yr. following treatment
- Yuflyma is an adalimumab biosimilar with a high-concentration, low-volume and citrate-free formulation & has been approved across all 10 indications for multiple chronic inflammatory diseases, including RA, polyarticular JIA, PsA, AS, CD, UC, HS, PsO, adult uveitis, and pediatric uveitis
Published: Jan 31, 2022
Product: N/A
- Biogen is eligible to receive ~ $2.3B for its stake in the joint venture which includes $1B in cash at closing, $812.5M at 1st anniversary & $437.5M at 2nd anniversary of the transaction close & is also eligible to receive $50M upon achievement of commercial milestones
- Biogen will also obtain commercial rights for Byooviz (biosimilar, ranibizumab) along with SB15 (aflibercept), a proposed biosimilar referencing Eylea
- Additionally, both companies have built the industry-leading anti-TNF portfolio in the EU including marketed products Benepali (biosimilar, etanercept), Imraldi (biosimilar, adalimumab), and Flixabi (biosimilar, infliximab)
Related Post: Insights+ Key Biosimilars Events of December 2021
