Biosimilars in Oncology Flashcards
What are biosimilars?
is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product
- it is similar to the reference medicinal product in terms of quality, safety, efficacy and biological activity
What are the benefits of biosimilars?
cost benefit
- biosimilars offer lower cost for equal quality
supporting a sustainable, competitive market
- biosimilars induce competition with subsequent lower innovator prices
potential for earlier patient access
- patients may be able to access costly advanced medicines earlier with resultant health gain
availability of budget for treatment of more patients
availability of budget for other treatments
What are the advantages of biosimilars?
foster innovation
- original reference products may be improved (e.g. new formulation)
- may prompt novel products
potentially mitigate risk of shortages
What is filgrastim? What is it used for?
is a granulocyte colony-stimulating factor (G-CSF) that stimulates the growth/production of neutrophils from bone marrow
is used to manage and treat neutropenia in patients with myelosuppression from chemotherapy or radiation, which increases the risk of infection and related events.
What are the factors affecting bio similar production?
marketing authorisation
supply guarantee, logistics and support
pharmaceutical considerations
presentation
packaging
clinical data
manufacturer experience
services to support implementation
How do you differentiate between biologics?
supply chain
price
product attributes
clinical trial data
When can biologicals be substituted/switched?
decision to change or switch should be taken by the physician having grasped a deep understanding of the product, informing the patient and closely monitoring the patient at all times in collaboration with nurses
automatic substitution, which might be practice for generics, should therefore be avoided in the field of biosimilars.
What are human factors that are barriers to biosimilar use?
clinician resistance
- lack of confidence in efficiency, reluctance to switch established patients and fear of hypersensitivity
patient resistance
time and capacity
- E-prescribing set up, staff training and patient identification
What are the systemic/pathway barriers to biosimilar use?
reference biologics may have
- enhanced stability data
- rapid infusion schedules
- off label indication
- alternatives routes of administration
- pharm funded service/research
What are global barriers to biosimilar use?
a reluctance to swap established patients to biosimilars
reluctance of prescribers to use biosimilars
insurance adaption/ payer preferences
lack of regulatory pathways
sourcing and quality
What stakeholders need to be considered when developing biosimilars?
INTERNAL
clinical - consultant, nursing, pharmacists
pharmacy - purchasing, dispensary, clinical, IT systems
trust - DTC, finance
EXTERNAL
industry - biosimilars, originator
regulatory - MHRA, EMA
professional - BOPA, ESMO
other - NHS England, clinical trial sponsors
What are ideas to make biosimilars more familiar to health care professionals and general population?
Identify and engage key clinical stakeholders – FAQs etc
Run education sessions
Involve Patient groups
Develop policies for introduction in local trusts
What is the cancer vanguard project?
a project that was established to pilot and roll out new models of care that will provide innovative high quality cancer care across the whole patient pathway.
involved
- developing central repository of information for the induction of rituximab
- increasing patient engagement
- staff education
-
