№ lp_1_2_57594
File format: docx
Character count: 7022
File size: 178 KB
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
Price: 8 / 10 USD
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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
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
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
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
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
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
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.
Note:
Year
Topic:
Education, Disability, Stakeholder Group
Document Type:
Form
Institution:
Ministry of Education
Author:
Ministry of Education
Target Audience:
Disabled people, communities, education sector professionals, disability advocacy groups
Context:
Form for expressing interest in joining a stakeholder group to improve education for disabled learners and those with additional learning support needs.
Year:
2023
Region / City:
Bristol
Topic:
Feasibility Awards, Research Funding, Translation and Commercialisation
Document Type:
Application Form
Institution:
Consumer Lab, University of Bristol
Author:
Consumer Lab
Target Audience:
Academic researchers, industry partners
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Funding scheme:
Business Interaction Voucher (BIV)
Programme:
Consumer Lab
Funding body:
Biotechnology and Biological Sciences Research Council (BBSRC)
Maximum funding amount:
£50,000 (inclusive of VAT)
Funding type:
Proof-of-concept research funding
Eligible applicants:
Academic institutions with non-university partners
Payment terms:
100% directly incurred costs and 100% directly allocated staff costs
Project duration:
Up to six months
Collaboration requirement:
At least one non-university partner
Geographic scope:
United Kingdom
Administering institution:
University of Bristol
Submission method:
Email
Submission contact:
[email protected]
Application type:
Expression of Interest form
Research focus:
Early-stage academic–industry collaboration
Document type:
Funding application form
Year:
2025
Region / City:
Nepal
Theme:
Budget Allocation, Public Health
Document Type:
Terms of Reference
Organization / Institution:
Action Against Hunger (ACF) Nepal
Author:
Action Against Hunger (ACF) Nepal
Target Audience:
Consultants, Health and Nutrition Policy Experts, Government Entities
Period of Activity:
December 20, 2025 – February 20, 2026
Approval Date:
December 2025
Date of Changes:
N/A
Note:
Year
Year:
2025
Region / City:
Uganda, Kampala
Subject:
Procurement
Document Type:
Expression of Interest (EOI)
Organization / Institution:
GOAL Relief and Development Organization
Author:
GOAL Uganda
Target Audience:
Suppliers of goods, services, and works
Period of Validity:
2025-2028
Approval Date:
24th March 2025
Amendment Date:
14th April 2025
Note:
Description
Year:
2021
Region / City:
Hastings, Victoria
Subject:
Outside School Hours Care Service
Document Type:
Expression of Interest
Organization:
Hastings Primary School
Author:
Barbara Evans
Target Audience:
Service providers
Period of Action:
2021-2025
Approval Date:
16th July 2021
Modification Date:
N/A
Context:
The document is an official invitation for service providers to submit an expression of interest for providing Outside School Hours Care at Hastings Primary School.
Year:
2024
Region / City:
Unity State, Bentiu State Hospital, Rubkona County
Topic:
Trachomatous Trichiasis Surgery Audit
Document Type:
Call for Expression of Interest (EOI)
Organization:
Christian Blind Mission (CBM)
Target Audience:
Ophthalmologists, certified WHO Trichiasis surgery trainers
Period of Activity:
November 2024
Approval Date:
Not specified
Amendment Date:
Not specified
Consultancy Fee:
USD 6,948
Closing Date:
15th November 2024
Location:
Bentiu State Hospital, Rubkona County, Unity State
Consultancy Duration:
18th - 26th November 2024
Expert Profile:
Ophthalmologist or certified WHO Trichiasis Surgery Trainer
Description:
Consultancy request for an ophthalmologist or certified WHO Trichiasis surgery trainer to audit the quality of Trachomatous Trichiasis surgeries performed in Unity State, South Sudan, by reviewing post-operative follow-up data and surgical practices.
Year:
2017
Region / City:
International
Subject:
Pharmaceutical Industry
Document Type:
Request Form
Agency / Institution:
Access Consortium
Author:
ACSS NCE WG, ACSS NCEWSP, ACSS NAS WSI, Access NAS WSI
Target Audience:
Pharmaceutical companies, regulatory agencies
Effective Period:
From 2017 to ongoing
Approval Date:
September 2017
Amendment Dates:
March 2018, January 2019, January 2021, January 2026
Year:
2026
Region / City:
Rajasthan
Subject:
Skill Development
Document Type:
Expression of Interest (EOI)
Organization:
Rajasthan Skill and Livelihoods Development Corporation (RSLDC)
Author:
N/A
Target Audience:
Eligible national agencies, business houses, industry bodies, government institutions, PSUs, universities, colleges, ITIs, polytechnics, and other skill training providers
Period of Validity:
N/A
Approval Date:
22 January 2026
Amendment Date:
N/A
Note:
Description
Year:
2025
Region / City:
Nigeria
Topic:
Third Party Logistics (3PL) Services
Document Type:
Expression of Interest (EOI)
Organization / Institution:
Malaria Consortium
Author:
Malaria Consortium
Target Audience:
Bidders for 3PL Services
Period of Validity:
Up to 2 years, extendable
Approval Date:
N/A
Amendment Date:
N/A
Note:
Description
Year:
2023
Region / City:
Kenya
Theme:
Community Engagement, Resilience, Countering Violent Extremism
Document Type:
Application Form
Organization / Institution:
GCERF
Author:
GCERF
Target Audience:
Organizations applying for Principal Recipient role
Duration:
36 months
Approval Date:
N/A
Modification Date:
N/A