№ lp_2_3_18284
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This document outlines the submission to the Pharmaceutical Benefits Advisory Committee (PBAC) for listing Yuflyma, a biosimilar to Humira, on the PBS for various indications, including Crohn’s disease, ulcerative colitis, psoriasis, and hidradenitis suppurativa.
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
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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
Hyrimoz® adalimumab biosimilar submission for PBS listing
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
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
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: Yuflyma Humira Biosimilar