Insights+ Key Biosimilars Events of February 2021

 Insights+ Key Biosimilars Events of February 2021

Insights+ Key Biosimilars Events of February 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 Feb, Biocon collaborated with CHAI to expand access to its oncology biosimilar while Viatris’ Kixelle got EC’s approval and it launches Hulio in Canada.  Our team at PharmaShots has summarized 14 key events of the biosimilar space of Feb 2021

Celltrion Received Health Canada’s Approval for Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis

Published: Feb 02, 2021

Product: Remsima SC (biosimilar, infliximab)

  • The Health Canada has granted a NOC which is based on clinical evidence for Remsima/CT-P13 SC vs CT-P13 IV up to 1year in patients with RA. The results demonstrated that switching patients from Remsima IV to its SC formulation @30wks. is comparable to maintaining Remsima SC up to 54wks.
  • The therapy has shown similar efficacy and safety profile of CT-P13 IV and provides patients an opportunity of self-administration to control their own treatment
  • The company applied patent protection until 2038 for Remsima SC in ~ 100 countries throughout North America, EU and Asia and will be the first product to enter the Canadian market

YL Biologics Reported the NDA Submission of YLB217 (biosimilar product of long-acting erythropoiesis stimulating agent Nesp)

Published: Feb 02, 2021

Product: YLB217 (biosimilar referencing Nesp)

  • YLB reported the NDA filing of YLB217, a biosimilar product of long-acting erythropoiesis-stimulating agent Nesp, which YLB solely developed, was executed through Yoshindo
  • On Sept 08, 2017, YLB signed a technology transfer agreement with CJ Healthcare, including exclusive development and marketing rights for Nesp biosimilar and started domestic development with the sponsorship of Yoshindo
  • In Jan’2019, YLB has conducted a P-III study that assesses YLB217 in 136 patients with renal anemia at 25 centers in Japan. Based on this, Yoshindo submitted a manufacturing and marketing approval application in Japan

Biocon Biologics Signed an Agreement with CHAI to Expand Access to its Oncology Biosimilars in 30 Countries

Published: Feb 05, 2021

Product: Oncology Biosimilar

  • Biocon and Clinton Health Access Initiative collaborate to expand the offering of oncology biosimilars in over 30 countries including Africa and Asia as a part of the Cancer Access Partnership (CAP)
  • The collaboration strengthens Biocon’s mission to address unmet needs of patients in Asia and Africa for advanced cancer therapies via cost effective biosimilars. The collaboration follows the initiation of our Mission 10 cents to provide insulins for people with diabetes in LMICs
  • Biocon will initially supply bTrastuzumab and bPegfilgrastim and will expand the arrangement to include other biosimilars

Enzene Received Marketing Authorization for Teriparatide (biosimilar) in India

Published: Feb 05, 2021

Product: Teriparatide (biosimilar)

  • The company received DCGI’s MA for Teriparatide (biosimilar) for the treatment of Osteoporosis vs anti-resorptive therapies such as bisphosphates and SERMs
  • The approved product will be marketed through Alkem Laboratories as well as it explores other potential partnering opportunities
  • Teriparatide will be launched in a fully compliant pen device

Celltrion Initiated P-III Study of CT-P42 (biosimilar, aflibercept)

Published: Feb 08, 2021

Product: CT-P42 (biosimilar, aflibercept)

  • Celltrion has launched a global P-III clinical trial of CT-P42 which is an investigational biosimilar candidate referencing Regeneron’s Eylea (aflibercept)
  • The study will enroll 300 patients with DME and aims to compare CT-P42’s efficacy, safety, pharmacokinetics, and immunogenicity against Eylea
  • Celltrion adds CT-P42 to its pipeline of other investigational biosimilars, including CT-P17 (referencing Humira), CT-P16 (referencing Avastin), CT-P39 (referencing Xolair), CT-P41 (referencing Prolia), and CT-P43

Lannett Expanded its Partnership with HEC to Include Biosimilar Fast-Acting Insulin

Published: Feb 10, 2021

Product: Biosimilar Fast-Acting Insulin

  • The companies collaborated to co-develop Insulin aspart while Lannett granted exclusive US commercialization rights of insulin aspart to HEC
  • Lannett will fund the clinical development requirements and will manage the clinical & regulatory steps specific for the FDA’s approval while HEC continues to develop the product and related manufacturing infrastructure. Both companies will share the profits of the venture
  • Insulin aspart is a short-acting (fast-acting) insulin typically taken just before eating, is used to treat adults with T1D & T2D

Biocon Biologics and Viatris Received EC’s Approval for Kixelle (biosimilar, insulin aspart) for Diabetes Mellitus

Published: Feb 15, 2021

Product: Kixelle (biosimilar, insulin aspart)

  • The EC approval follows CHMP’s positive recommendation for Kixelle to treat DM in adults, adolescents, and children aged ≥1yr. The biosimilar has been approved as a 100 units/ml solution for injection in vial & pre-filled pen presentations
  • The EC’s CMA is valid in all EU Member States as well as in the EEA countries including Iceland, Liechtenstein, and Norway
  • The approval will allow affordable access to a rapid-acting insulin analog for people with diabetes in the EU

Fujifilm Kyowa Kirin and Mylan EPD Launched Adalimumab Biosimilar in Japan

Published: Feb 15, 2021

Product: Adalimumab Biosimilar

  • This is the first launch of a biosimilar to Humira in Japan. Mylan EPD will lead the commercialization of the biosimilar
  • The launch is a testament to the power of Viatris’ unique Global Healthcare Gateway which helps partners to further expand patient access to more affordable medicines across the globe
  • In 2018, Fujifilm Kyowa Kirin Biologics and Viatris collaborated for the commercialization of Hulio in the EU and Viatris has commercialized the product in 20+ countries across the region. In 2019, the companies expanded the partnership globally

Celltrion Received EC’s Approval for Yuflyma (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Diseases

Published: Feb 16, 2021

Product: Yuflyma (biosimilar, adalimumab)

  • The EC approval follows CHMP’s positive recommendation for Yuflyma (high concentration formulation) granted in Dec’2020. The approval covers all 13 intended indications to treat multiple chronic inflammatory diseases
  • The approval is based on analytical, pre/ clinical studies, demonstrating that Yuflyma is comparable to the reference product, in terms of safety, efficacy, PK/PD, and immunogenicity up to 24wks. and 1yr following treatment
  • The company will take ECDRP to minimize lead time to launch the product in the UK and remains committed to delivering innovative and affordable medications

Sandoz Launches Hyrimoz (biosimilar, adalimumab) in Canada

Published: Feb 16, 2021

Product: Hyrimoz (biosimilar, adalimumab)

  • The company expands its portfolio with the marketing of the 5th biosimilars in Canada. Hyrimoz is indicated for use in nine indications of the reference (Humira) in the field of rheumatology, gastroenterology and dermatology
  • Sandoz Canada has completed the pCPA negotiations for Hyrimoz, which is the first step in securing public reimbursement
  • Hyrimoz is a fully human TNF blocker and is available in 40 mg/0.8 mL & 20 mg/0.4mL in a prefilled syringe, 40 mg/0.8 mL in autoinjector in SensoReady Pen autoinjector designed for patients with limited dexterity

Coherus Reported the US FDA’s Acceptance of BLA for CHS-1420 (biosimilar, adalimumab)

Published: Feb 18, 2021

Product: CHS-1420 (biosimilar, adalimumab)

  • The US FDA has accepted the BLA under the 351(k) for CHS-1420 with an anticipated BsUFA date as Dec’2021
  • The company plans to launch the CHS-1420 in the US on or after Jul 01, 2023 as per the terms of an agreement with AbbVie
  • Coherus collaborated with Junshi in Feb’2021 to in-license toripalimab in the US and Canada. Additionally, Coherus will market Udenyca (pegfilgrastim) in the US and plans to launch biosimilars of Humira, Avastin and Lucentis in 2023, following their approval

Viatris Launched Hulio (biosimilar, adalimumab) in Canada

Published: Feb 18, 2021

Product: Hulio (biosimilar, adalimumab)

  • Health Canada has approved Hulio, a biosimilar referencing AbbVie’s Humira (adalimumab), which is now available in Canada. It is licensed from Fujifilm Kyowa Kirin and approved for all adalimumab indications
  • The approval was based on an analytical, pre/ clinical program. Fujifilm Kyowa Kirin conducted a P-III ARABESC study that demonstrated no differences in terms of safety, efficacy, and immunogenicity compared to its reference product in patients with RA
  • Fujifilm Kyowa Kirin and Viatris aims to expand patient access to more affordable biosimilar medicines across the globe, including in Canada

Fresenius Kabi Launched Idacio (biosimilar, adalimumab) for Multiple Chronic Inflammatory Conditions in Canada

Published: Feb 19, 2021

Product: Idacio (biosimilar, adalimumab)

  • Health Canada has authorized Idacio on Oct 30, 2020, for marketing in Canada and is now available for all indications of the reference (Humira) in the field of rheumatology, gastroenterology and dermatology
  • Health Canada’s approval was based on analytical, pre/ clinical data that demonstrated similar PK, efficacy, safety and immunogenicity to the Humira. Idacio is the first Fresenius Kabi’s biosimilar introduced in North America
  • KAbiCare is a patient support program that provides patients with information, tools, support during the treatment and offers reimbursement navigation, financial assistance, as well as customized services to help an individual in clinic processes

Tanvex Reported Results of TX05 (biosimilar, trastuzumab) in P-III Study for HER2-Positive Early Breast Cancer

Published: Feb 20, 2021

Product: TX05 (biosimilar, trastuzumab)

  • The P-III study evaluates the efficacy and safety of TX05 vs Herceptin (trastuzumab) in patients with human epidermal growth factor receptor 2-positive early breast cancer
  • The 1EPs was an assessment of pCR following neoadjuvant therapy and definitive surgery in the per-protocol population
  • Results: Patients achieved pCR (48.8% vs 45.3%) in the per-protocol population

Image Source: Amgen Biosimilar

Related Post: Insights+ Key Biosimilars Events of January 2021

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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