Insights+ Key Biosimilars Events of September 2021

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Insights+ Key Biosimilars Events of September 2021

Insights+ Key Biosimilars Events of September 2021

  • 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 September, Sandoz entered into a commercialization and license agreement with Bio-thera to commercialize BAT1706, a proposed biosimilar Avastin (bevacizumab), Hetero's Tocira (biosimilar, tocilizumab) received the DCGI's EUA for the treatment of COVID-19 in hospitalized adults. Our team at PharmaShots has summarized 11 key events of the biosimilar space of September 2021

Fresenius Kabi Reports Results of MSB11456 (biosimilar, tocilizumab) in Two Clinical Trials for the Treatment of Rheumatoid Arthritis

Published: Sept 7, 2021

Product: MSB11456 (biosimilar, tocilizumab)

  • The 1st P-I study evaluates MSB11456 as SC formulation vs US-Actemra/EU-RoActemra & 2nd P-I study evaluate MSB11456 vs Actemra as IV formulation in patients with moderately to severely active RA
  • Both studies met all 1EPs & 2EPs i.e., PK equivalence demonstrated in all 3 treatment groups & no differences in safety and immunogenicity were identified. The first P-I study also showed the similarity b/w MSB11456 & Actemra/RoActemra at PD level
  • The company has completed the patient enrolment in the P-III study of MSB11456
  • (biosimilar, tocilizumab) vs RoActemra for patients with the same indications across EU

Hetero's Tocira (biosimilar, tocilizumab) Receives the DCGI's EUA for the Treatment of COVID-19 in Hospitalized Adults

Published: Sept 7, 2021

Product: Tocira (biosimilar, tocilizumab)

  • DCGI has granted a EUA for tocilizumab in India for the treatment of COVID-19 in hospitalized adults who receives systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO
  • Hetero's Tocira will be marketed by Hetero Healthcare in India & manufactured by Hetero Biologics
  • Tocilizumab (400mg/20ml) is the biosimilar referencing Roche's Actemra/RoActemra and is expected to be available at the end of Sept'21

Sandoz Enters into a Commercialization and License Agreement with Bio-Thera to Commercialize BAT1706, a Proposed Biosimilar Avastin (bevacizumab)

Published: Sept 9, 2021

Product: BAT1706, a Proposed Biosimilar Avastin (bevacizumab)

  • Bio-Thera to receive an upfront, milestones along with royalties on product sales & will be responsible for the development, manufacturing, supply of BAT1706
  • Sandoz to get rights for the commercialization of the therapy upon approval in the US, EU, Canada, and other countries. Bio-Thera's BAT1706 has completed extensive biosimilar studies, including a global P-III study
  • Bevacizumab is a humanized mAb that targets VEGF. Avastin has been approved in the US and EU to treat multiple types of cancer

Samsung Bioepis Reports Results of Post-Hoc Analysis from P-III Study of Byooviz (biosimilar, ranibizumab) for the Treatment of nAMD

Published: Sept 10, 2021

Product: Byooviz (biosimilar, ranibizumab)

  • The P-III study evaluates Byooviz (0.5 mg, IVT) vs ranibizumab in 634 patients with nAMD. The results will be presented at EURETINA 2021
  • The 1EPs are changed from baseline in BCVA @8wks. and change in CST @4wks. with both EPs, followed by 52wks. The post-hoc analysis showed that the baseline age, BCVA, CST, and total lesion size were identified to be associated with the visual acuity & anatomical outcomes
  • In subgroup analysis, similar visual outcomes of 2 products in change from baseline in BCVA in multiple subgroups were observed & support an equivalent clinical efficacy. Byooviz is an effective & valuable treatment option for nAMD patients globally

Alvotech Reports Results of AVT02 (biosimilar, adalimumab) in AVT02-GL-302 Study to Treat Chronic Diseases

Published: Sept 10, 2021

Product: AVT02 (biosimilar, adalimumab)

  • The AVT02-GL-302 study evaluates AVT02 in 568 patients at ~30 centers in the EU. Patients were randomized into either of the two arms of the switching module: The first group continues with Humira & the 2nd group is given AVT02 and Humira for an additional 16wks.
  • The switching study (AVT02-GL-302) aims to support the approval of AVT02 in the US as an interchangeable biosimilar product with the high concentration (100mg/mL) dosage forms of Humira
  • The results showed the bioequivalence of repeated switches b/w Humira & Alvotech’s AVT02, no significant differences were identified in clinical efficacy, safety, or immunogenicity b/w the switching cohort and Humira

Samsung Bioepis Presents Five-year Follow-up Results of Ontruzant (biosimilar, trastuzumab) in Early or Locally Advanced HER2 Positive Breast Cancer at ESMO 2021

Published: Sept 12, 2021

Product: Ontruzant (biosimilar, trastuzumab)

  • The P-III study evaluates the cardiac safety profiles & efficacy of Ontruzant vs reference trastuzumab in 367 patients with HER2 positive early or LA BC for 4yrs. after randomization
  • Patients were randomized to receive 8 cycles of either Ontruzant or TRZ with concurrent neoadjuvant CT. After surgery, patients received 10 cycles of biosimilar trastuzumab or TRZ completing 1yrs. of treatment
  • In follow up study, the reduction in asymptomatic LVEF at both groups, 3 patients recovering with LVEF = 50%, no cases of heart failure or cardiac death observed, EFS rates (82.8% vs 79.7%), OS rates (93.1% vs 86.7%), number of events i.e. recurrence, progression, or death (17.2% vs 21%)

Alvotech's AVT02 (a proposed biosimilar to Humira) Receives CHMP's Positive Opinion for the Treatment of Autoimmune Diseases

Published: Sept 17, 2021

Product: AVT02 (a proposed biosimilar to Humira)

  • The EMA's CHMP has recommended the approval of Alvotech's AVT02 (100 mg/mL), a proposed biosimilar to Humira (adalimumab)  to treat AD in the EU
  • The EC has been assigned to discuss the marketing authorization for AVT02. If approved, AVT02 will be extended to all EU member states along with other countries in the EEA, Iceland, Liechtenstein, and Norway
  • Adalimumab is used to treat certain inflammatory conditions. Alvotech's pipeline contains several mAb and fusion-protein biosimilar candidates that focus on autoimmunity, oncology, and inflammatory conditions to improve QoL for patients globally

Biocad Presents Results of BCD-021 (biosimilar, bevacizumab) in P-III Study for the Treatment of Non-Squamous Non-Small Cell Lung Cancer at ESMO 2021

Published: Sept 17, 2021

Product: BCD-021 (biosimilar, bevacizumab)

  • The P-III study evaluates the efficacy, safety & immunogenicity of BCD-021 (q3w for 6 cycles) vs reference Avastin + paclitaxel & carboplatin in 357 patients with stage IIIB or IV nonsq. NSCLC across Russia, Belarus, Ukraine & India
  • The study showed an equivalent efficacy, ORR (34.6% & 33.8%), 341 patients had 1 CT scan after initiation of treatment, patients achieved stable disease (31.7% & 33.8%); CR (1.5% & 0.7%); PR (33.2% & 33.1%) @18wks. & continue with BCD-021 until disease progression, death, or unacceptable toxicity
  • Patients experienced AEs (91.3% vs 93.4%); serious AEs (13.6% vs 10.9%), treatment discontinuation due to AEs, treatment-related serious AEs (3.4% vs 2.2%), respectively

Tanvex Presents Results of TX05 (biosimilar, trastuzumab) in P-III Study for the Treatment of HER2-Positive Early Stage Breast Cancer at ESMO 2021

Published: Sept 20, 2021

Product: TX05 (biosimilar, trastuzumab)

  • The P-III study evaluates TX05 (biosimilar, trastuzumab) vs Herceptin in 809 patients with HER2-positive early-stage breast cancer
  • The results showed that the proportions of patients that meet pCR criteria for equivalence were highly similar b/w TX05 (48.8%) and TRA (45.3%) cohorts; ORR (84.3%) & (85.0%); CR; PR and stable disease were also highly similar, patients experienced TEAEs (62.4% vs 62.5%), respectively
  • Additionally, the therapy was well tolerated & the safety profile was consistent with the known profile of TRA

Samsung Bioepis and Biogen's Byooviz (biosimilar, ranibizumab) Receives the US FDA's Approval for the Treatment of Retinal Vascular Disorders

Published: Sept 21, 2021

Product: Byooviz (biosimilar, ranibizumab)

  • The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study that evaluates the efficacy, safety, PK & immunogenicity of SB11 (0.5mg) vs Lucentis in a ratio (1:1) in 705 patients with wet AMD
  • The results showed LS mean change in BCVA from baseline @52wks. (9.79 vs 10.41 letters) & LS mean change in CST (-139.55 vs -124.46 µm) while PK, safety including the incidence of TEAEs & immunogenicity profile were comparable at all timepoints @52wks.
  • Byooviz marks the 1st ophthalmology biosimilar approved in the US. In Nov'19, Samsung Bioepis & Biogen had entered into a commercialization agreement for 2 ophthalmology biosimilars i.e., SB11 & SB15

Apobiologix's Bambevi (biosimilar, bevacizumab) Receives Health Canada Approval for Multiple Cancer Indications

Published: Sept 27, 2021

Product: Bambevi (biosimilar, bevacizumab)

  • Apobiologix expands its footprints in Canada with the approval of Bambevi + CT to treat colorectal, lung, brain, and ovarian cancer
  • The approval is coupled with well-established Apobiologix supportive care products that enable the company to transform access to affordable therapies in oncology and other indications
  • In 2016, Apobiologix launched its first product, Grastofil (filgrastim) followed by the launch of Lapelga in 2019 in Canada. Additionally, Apobiologix is the first company to offer a portfolio of G-CSF biosimilars

Source: Biopharma Reporter

Related Post: Insights+ Key Biosimilars Events of August 2021


Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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