Insights+ Key Biosimilars Events of June 2022

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Insights+ Key Biosimilars Events of June 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 June, Organon entered into an agreement with Henlius to commercialize Perjeta (pertuzumab) and Prolia/Xgeva (denosumab) biosimilars, Sandoz launched a new global ‘Act4Biosmilars’ initiative to increase the biosimilar adoption worldwide. Our team at PharmaShots has summarized 15 key events of the biosimilar space of June 2022

Samsung Bioepis Presents Results of SB5 (biosimilar, adalimumab) in P-I and (PROPER) Study for Rheumatoid Arthritis and Other Inflammatory Diseases at EULAR 202

Published: June 01, 2022

Product: SB5 (biosimilar, adalimumab)

  • The P-I study evaluates the new SB5 formulation (40mg/0.4 mL) vs the original SB5 formulation (40mg/0.8 mL) in male patients with RA & other inflammatory diseases. The results showed the clinical equivalence b/w 2 formulations, were well tolerated with similar safety profiles
  • The pan-EU real-world (PROPER) study evaluates Humira vs SB5 in 1000 patients with RA, axSpA, PsA, UC, or CD. Eligible patients had been transitioned to SB5 as part of routine treatment following 16wks. with reference ADL
  • Results were recorded for 24wks. prior to the switch & 48wks. following the switch to SB5. The study showed that adalimumab therapy's effectiveness persisted on the biosimilar after 48wks. and the majority of patients opted to continue on SB

Sandoz Launches New Global ‘Act4Biosmilars’ Initiative to Increase the Biosimilar Adoption Worldwide

Published: June 01, 2022

Product: N/A

  • Sandoz launched ‘Act4Biosmilars’ to address health inequity & inequality globally along with increase patient's access to advanced therapies & adoption by 30% in over 30 countries by 2030 
  • The Steering Committee is developing an Action Plan to provide the roadmap and tools to improve the approvability, accessibility, acceptability, and affordability (4As) of biosimilars with a group of biosimilar experts & key stakeholders
  • Act4Biosimilars.com lists the 12 goals that have been identified by Steering Committee to fulfill the mission under the 4As to ensure equitable pricing, involve patients in treatment decisions & streamline the biosimilar development

Lannett Reports Updates of Biosimilar Insulin Glargine

Published: June 01, 2022

Product: N/A

  • The company provided updates on the clinical study evaluating the PK & PD of biosimilar insulin glargine that was jointly developed by Lannett & HEC Group of companies
  • 50% of the patients enrolled in the study have received the first of the two doses whereas 33.3% of the patients have received the second dose. There were no AEs indicated from the study so far & the company will present the results from the study by the end of 2022
  • Lannett expects to file a BLA for its biosimilar to be evaluated in comparison with Sanofi’s Lantus in early 2023 & also expects to commercialize biosimilar insulin glargine by H1’24

Biogen and Samsung Bioepis Launch Byooviz (biosimilar, ranibizumab) for the Treatment of Retinal Vascular Disorders in the US

Published: June 02, 2022

Product: Byooviz (biosimilar, ranibizumab)

  • The company launches Byooviz, a biosimilar referencing ranibizumab as an affordable treatment option for retinal vascular disorders in the US. The therapy is expected to be available in July 2022 through major distributors across the US with a list price of $1,130 per single-use vial to administer 0.5g via IV inj. 
  • This list price is ~40% lower than the list price of Lucentis. Ranibizumab is used to treat wet AMD, DME, PDR, macular edema secondary to retinal vein occlusion, or CNV
  • Byooviz marks the first US FDA-approved ophthalmology biosimilar while Byooviz was also approved in Canada, the EU & UK. Samsung is responsible for the development, regulatory registration & manufacture of the products while Biogen is responsible for commercialization

Biogen and Bio-Thera Solutions Present Results of BIIB800 (biosimilar, tocilizumab) in P-III Trial for Rheumatoid Arthritis at EULAR 2022

Published: June 06, 2022

Product: BIIB800 (biosimilar, tocilizumab)

  • The P-III study evaluates BIIB800 (q4w, IV, at a dose of 8mg/kg for the first 24wks.) vs Actemra/Roactemra in 621 patients with moderate to severe RA with inadequate response to methotrexate
  • The results showed that biosimilar BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to tocilizumab, ACR20 response rates (68.97% vs 64.82%) @12wk. & (69.89% vs 67.94%) @24wk., estimated difference b/w two groups were within the pre-defined equivalence margins (4.15% & 1.94%) @12 & 24wk.
  • The treatment groups showed equivalent PK, safety, and immunogenicity in terms of serum trough tocilizumab levels, the incidence of treatment-emergent AEs, and anti-drug Ab positivity

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for the Treatment of Rheumatoid Arthritis

Published: June 07, 2022

Product: Riabni (biosimilar, rituximab)

  • The US FDA has approved Riabni, a biosimilar to Rituxan in combination with methotrexate for adults with mod. to sev. active RA who had an inadequate response to ≥1 TNF antagonist therapies
  • The clinical study evaluates Riabni (CD20-directed cytolytic Ab) vs rituximab in 311 patients with RA. The primary efficacy of EPs is the change in DAS28-CRP from baseline @24wk. The results were within the predetermined equivalence margin indicating that the two therapies were clinically equivalent & were similar in terms of safety, PK & immunogenicity
  • Riabni was approved to treat NHL, CLL, GPA & MPA in adult patients. The company's portfolio includes 11 biosimilars that could be used to treat CID & cancer including 5 US & 3 EU-approved biosimilars

STADA and Alvotech Launch AVT02 (biosimilar, adalimumab) for the Treatment of Inflammatory Conditions

Published: June 09, 2022

Product: AVT02 (biosimilar, adalimumab)

  • STADA launched Hukyndra a citrate-free, high-concentration (100 mg/mL) biosimilar to adalimumab across immunology, oncology & ophthalmology to patients & caregivers in selected EU countries incl. France, Germany, Finland & Sweden while in further EU countries in coming mos. 
  • The Humira biosimilar consist 40mg/0.4 mL custom-designed pre-filled auto-injector pens, 40mg/0.4 mL & 80mg/0.8 mL pre-filled syringe presentations with 100mg/mL adalimumab. STADA supports Hukyndra's launch in national markets with educational materials & patient care programs
  • Adalimumab marks 1st biosimilar developed in collaboration with Alvotech. Hukyndra biosimilar received approval in the EU & was valid in the 27 EU member countries, Norway, Iceland & Liechtenstein

Samsung Bioepis Presents P-III Study Results of SB12, a Proposed Biosimilar to Soliris for Paroxysmal Nocturnal Hemoglobinuria at EHA 2022

Published: June 10, 2022

Product: SB12

  • The P-III study evaluates SB12 vs eculizumab in 50 patients with PNH. At 26wk., the treatment was changed to reference eculizumab (TS1) or SB12 (TS2), and the new regimen was continued until 50wk.
  • The purpose of the study was to determine clinical efficacy by evaluating the level of LDH, safety, PK, PD, and immunogenicity of SB12 and reference eculizumab
  • The results showed clinical equivalence in efficacy, safety, PK, PD, and immunogenicity b/w SB12 and reference eculizumab in patients with PNH. The study's results showed a 95% CI of mean difference in LDH level @26wk.; 90% CI ratio of time-adjusted AUEC of LDH b/w SB12 & eculizumab lay within the pre-defined equivalence margin

Celltrion and Nippon Kayaku Demonstrated Similar Effectiveness, Safety of CT-P6 (biosimilar, trastuzumab) in Retrospective Study for HER2+ Early Breast Cancer

Published: June 13, 2022

Product: CT-P6 (biosimilar, trastuzumab)

  • The retrospective study evaluates CT-P6 vs Herceptin in 44 patients with HER2+ early breast cancer who received trastuzumab therapy, CT & pertuzumab
  • The results showed similar effectiveness & safety measures, baseline characteristics were similar b/w groups, clinical CR & pCR rates were similar, 55% & 65% achieved clinical CR & pCR rates over 66.7% & 66.7% in reference trastuzumab, AEs were similar b/w groups, 1 patient experienced an infusion-related reaction
  • The results were published in The Breast. The results from an in vitro study showed that the biosimilar & trastuzumab both inhibit HER2-mediated AKT & ERK1/2 as a monothx. & combination with pertuzumab to prevent cell proliferation & colony formation

Innovent and Etana’s Bevagen (biosimilar, bevacizumab) Receive BPOM’s Approval for the Treatment of Cancers in Indonesia

Published: June 13, 2022

Product: Bevagen (biosimilar, bevacizumab)

  • BPOM has approved Bevagen (biosimilar, bevacizumab) for 5 indications incl. m-CRC, locally recurrent or m-TNBC, NSCLC, epithelial ovarian, fallopian tube, primary peritoneal cancer & CC. Each Bevagen single-use vial has a 4mL (25mg/mL) vial containing 100mg of bevacizumab
  • Based on product quality & manufacturing procedures, the approval in Indonesia certified Bevagen's compliance with the drug safety & efficacy requirements established by the Indonesian government
  • Following the license agreement with Innovent, Etana will commercialize Bevagen in Indonesia & can improve access to high-quality & affordable biosimilar drugs to satisfy the needs of cancer patients. Bevagen will be 1st locally produced and commercialized Chinese Ab therapy in Southeast Asia

Organon Entered into an Agreement with Henlius to Commercialize Perjeta (pertuzumab) and Prolia/Xgeva (denosumab) Biosimilars

Published: June 14, 2022

Product: Perjeta and Prolia/Xgeva Biosimilars

  • Henlius to receive $73M upfront & is eligible to receive an additional fee of $30M upon achievement of development, regulatory & commercial milestones & will lead the development & commercialization activities of the products if approved
  • Organon gets the commercialization rights for biosimilar candidates referencing Perjeta and Prolia/Xgeva (Ex- China including Hong Kong, Macau & Taiwan) for breast cancer & osteoporosis
  • Organon has an exclusive license option for global commercialization rights for a biosimilar candidate referencing Yervoy (ipilimumab, HLX13). The collaboration will expand the biosimilars portfolio & focus on women’s health with biosimilar candidates for osteoporosis & breast cancer

Henlius Reports the First Patient Dosing in P-III (HLX14-002-PMOP301) Trial of HLX14 (biosimilar, denosumab) to Treat Osteoporosis in Postmenopausal Women

Published: June 17, 2022

Product: HLX14 (biosimilar, denosumab)

  • The first patient has been dosed in P-III (HLX14-002-PMOP301) trial to evaluate HLX14 (SC) vs denosumab in a ratio (1:1) in postmenopausal women with osteoporosis at high risk of fracture
  • The 1EPs of the study were the percentage change in BMD at the lumbar spine from baseline to Day 365. The 2EPs include the percentage change in BMD at the total hip from baseline to Day 365; femoral neck from baseline to Day 365; serum type I collagen C-telopeptide & serum procollagen type 1 N-telopeptide from baseline to Day 29/92/183/274/365 along with safety, PK & immunogenicity
  • Denosumab has been approved globally for a range of indications i.e., osteoporosis, giant cell tumor of bone, skeletal-related events in patients with MM & bone metastases from solid tumors

Sandoz Reports the EMA Acceptance of Hyrimoz (biosimilar, adalimumab) Application

Published: June 17, 2022

Product: Hyrimoz (biosimilar, adalimumab)

  • The EMA has accepted the application for regulatory review of its biosimilar Hyrimoz (adalimumab) as a high concentration formulation of 100mg/mL (HCF) that comprises all indications covered by reference adalimumab incl. RA, CD, PsO, UC and uveitis
  • The submission was based on the P-I bridging PK study evaluating Hyrimoz (50mg/mL2) vs Hyrimoz HCF. The study met all its primary objectives & showed comparable PK & similar safety and immunogenicity b/w Hyrimoz & Hyrimoz HCF
  • The company has an established portfolio of biosimilars in immunology incl. Erelzi (biosimilar, etanercept), Zessly (biosimilar, infliximab) & Rixathon (biosimilar, rituximab). If approved, Hyrimoz, citrate-free HCF can provide low inj. volume & lower no. of inj. needed for patients who require an 80mg dosage

Formycons & Bioeq AG Receives CHMP Positive Opinion of FYB201 (biosimilar, ranibizumab) as 1L Treatment of Neovascular (wet) Macular Degeneration

Published: June 24, 2022

Product: FYB201 (biosimilar, ranibizumab)

  • The EMA’s CHMP has issued a positive opinion for approval of FYB201, a biosimilar to Lucentis (ranibizumab) for the treatment of patients with wet AMD and other serious ocular diseases incl. DME, PDR, ME due to retinal vein occlusion & CNV. The EC’s decision is expected at the end of August
  • The recommendation was based on the P-III study of FYB201 which showed comparable efficacy, safety, PK, and immunogenicity to the reference ranibizumab in patients with wet AMD
  • Under the license agreement with Bioeq, Teva has exclusive rights to distribute the product in the EU and other territories and is currently preparing for the launch of FYB201 in the EU

Celltrion Healthcare Receives CHMP Positive Opinion of CT-P16 (biosimilar, bevacizumab) as 1L Treatment of Non-Squamous Non-Small Cell Lung Cancer

Published: June 27, 2022

Product: CT-P16 (biosimilar, bevacizumab)

  • The EMA’s CHMP has adopted a positive opinion for the marketing authorization of a bevacizumab biosimilar candidate referencing EU-approved Avastin (CT-P16)
  • The positive opinion was based on the totality of evidence incl. the P-III study to evaluate the efficacy, PK & safety of CT-P16 vs EU-approved Avastin in patients with metastatic or recurrent nsq. NSCLC. The results were found to be well tolerated and demonstrated biosimilarity b/w the biosimilar and reference bevacizumab
  • CT-P16 is an anti-cancer mAb treatment developed as a candidate biosimilar to Avastin (bevacizumab). If CT-P16 is approved, it will be the third therapeutic oncology biosimilar in the company’s biosimilar pipeline

Related Post: Insights+ Key Biosimilars Events of May 2022


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.

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