№ lp_1_2_29823
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This document is a regulatory submission seeking approval for the listing of the biosimilar Hyrimoz® in various forms and strengths on the Australian PBS, comparing it with the reference biologic Humira® and outlining recommended PBS indications.
Year: 2024
Region / city: Australia
Topic: Biosimilars, pharmaceutical regulation
Document type: Submission report
Organ / institution: Australian Government, Pharmaceutical Benefits Advisory Committee (PBAC)
Author: Sandoz Pty Ltd
Target audience: Regulatory bodies, pharmaceutical industry professionals
Period of validity: 2024–2025
Approval date: 15 May 2024
Date of changes: March 2024
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
ADALIMUMAB, Injection 20 mg in 0.2 mL, 40 mg in 0.4 mL, and 80 mg in 0.8 mL for the treatment of non-infectious uveitis
Year: 2017
Region / City: Australia
Subject: Medical treatment, pharmaceutical submission
Document Type: Submission for Pharmaceutical Benefits Scheme (PBS) consideration
Organization: Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author: AbbVie Pty Ltd.
Target Audience: Medical professionals, regulatory authorities
Effective Period: 2017–2024
Approval Date: October 26, 2016
Amendment Date: Not specified
ADALIMUMAB 40 mg/0.8 mL injection, 2 x 0.8 mL cartridges, 2 x 0.8 mL syringes, 6 x 0.8 mL cartridges, 6 x 0.8 mL syringes - Purpose of Application
Year: 2013
Region / City: Australia
Theme: Pharmaceutical
Document Type: Pharmaceutical Submission
Agency / Institution: PBAC
Author: AbbVie Pty Ltd
Target Audience: Medical Professionals, Pharmacists
Effective Period: Ongoing
Approval Date: 23 July 2013
Date of Changes: Not specified
Supporting Statement – Part A Small Biotech Exception and Biosimilar Delay Information Collection Request for Initial Price Applicability Year 2027 (CMS-10844, OMB 0938-1443)
Year: 2027
Region / city: United States
Topic: Medicare Drug Price Negotiation Program
Document type: Supporting Statement
Organ / institution: Centers for Medicare & Medicaid Services (CMS)
Author: Centers for Medicare & Medicaid Services (CMS)
Target audience: Pharmaceutical industry, healthcare professionals, policymakers
Period of validity: 2026-2028
Approval date: Not specified
Modification date: Not specified
Expression of Interest (EOI) Form to Participate in the Access Consortium Biosimilar Medicines Work Sharing Initiative (BSWSI)
Year: 2021
Region / City: Global
Topic: Biosimilars, Pharmaceutical Regulation
Document Type: Form
Organization / Institution: Access Consortium
Author: Access BSWG
Target Audience: Pharmaceutical Companies, Regulatory Agencies
Effective Date: January 2021
Approval Date: January 2021
Changes Date: N/A
Submission for the PBS Listing of Yuflyma 80 mg in 0.8 mL Pre-filled Pen and Syringe as a Biosimilar to Humira
Year: 2023
Region / City: Australia
Topic: Biosimilar Medicines, Pharmaceutical Submission
Document Type: Regulatory Submission
Organization / Institution: Therapeutic Goods Administration, Pharmaceutical Benefits Advisory Committee
Author: Celltrion Healthcare Australia Pty Ltd
Target Audience: Healthcare Professionals, Policy Makers
Effective Period: Not specified
Approval Date: 30 June 2023
Amendment Date: Not specified
Note: Contextual Description
Persistence in treatment with TNF-alpha inhibitors in Spondyloarthritis: comparison between original and biosimilar drugs - a pilot study
Year: 2022
Region / city: Viseu Dão-Lafões
Topic: Spondyloarthritis, TNF-alpha inhibitors, Biosimilars, Treatment Efficacy, Safety
Document type: Research Study
Institution: Unidade Local de Saúde Viseu Dão-Lafões
Author: Inês Almeida, Liliana Saraiva, Miguel Tavares, Ana Teixeira, Maura Couto
Target audience: Healthcare professionals, researchers, rheumatologists
Period of validity: January 2010 - May 2022
Approval date: Not specified
Date of changes: Not specified
INFLIXIMAB (biosimilar) injection, 100mg, Inflectra®, Hospira
Year: 2015
Region / city: Australia
Subject: Pharmaceutical Submissions, Biosimilars
Document Type: Application for PBS Listing
Organization / Institution: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: Hospira
Target Audience: Healthcare professionals, regulatory authorities, pharmaceutical industry
Period of validity: Ongoing
Approval Date: N/A
Date of changes: N/A
Natalizumab and Tyruko (natalizumab biosimilar) for Treating Highly Active Relapsing-Remitting Multiple Sclerosis After at Least One Disease-Modifying Therapy: Systematic Review and Economic Model Addendum
Producing organisation: Bristol Technology Assessment Group
Document type: Addendum to systematic review and economic model
Subject: Clinical and cost effectiveness of natalizumab and its biosimilar in highly active relapsing-remitting multiple sclerosis
Interventions assessed: Natalizumab (intravenous and subcutaneous) and natalizumab biosimilar (Tyruko)
Population: Adults with highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy
Study inclusion criteria: Randomised controlled trials comparing eligible interventions or placebo
Comparators considered: Alemtuzumab, cladribine tablets, fingolimod, ocrelizumab, ofatumumab, ponesimod, interferon beta formulations, peginterferon beta 1a, glatiramer acetate
Manufacturers involved: Biogen and Sandoz
Assessment components: Clinical effectiveness review, network meta-analysis, cost-effectiveness modelling
Data sources: Company submissions, published literature, previous technology appraisals
Economic perspective: Cost-comparison submissions and EAG base case model
Geographical context: United Kingdom
Regulatory context: NICE technology appraisal process
TERIPARATIDE Injection 250 micrograms/mL Terrosa® Biosimilar Listing Submission 2020
Year: 2020
Country: Australia
Drug: Teriparatide
Brand: Terrosa®
Reference Brand: Forteo®
Manufacturer: Gedeon Richter Australia Pty Ltd
Regulatory Authority: TGA (Therapeutic Goods Administration)
Regulatory Status: Approved as biosimilar
Indications: Osteoporosis in postmenopausal women, primary osteoporosis in men, glucocorticoid-induced osteoporosis
PBAC Consideration: Minor submission for PBS listing
Dosage Form: Injection, 250 micrograms/mL, 2.4 mL multi-dose cartridge
Treatment Duration: 24 months
Comparator: Forteo®
Economic Analysis: Cost-minimisation
PBS Usage Estimate: Year 1: 0.48%, Year 6: 45.02%
Administration: Terrosa pen device requires assembly; Forteo prefilled pen
Endorsements: Authority Required (STREAMLINED) listing recommended by PBAC
Clinical Evidence: PK and Phase III trials confirming biosimilarity
Context: Regulatory submission detailing clinical, economic, and policy considerations for listing Terrosa® as a biosimilar to Forteo® on the PBS in Australia, including dosage, device differences, cost analysis, and PBAC recommendations.
Topics: Hyrimoz ADALIMUMAB Biosimilar