Workshop 9 - biologics and biosimilars Flashcards
What conditions are biologics indicated for?
Cancer
Opthalmology
Endocrinology
Inflammatory disease (RA, psoriasis, etc)
Why would a biosimilar be prescribed?
Medical switching: To optimise patient therapy
ADRs and tolerability issues.
change in disease state - unlikely
patient convenience - ergonomics, device preference, adherence etc
non medical switching : in clinically stable patients
- not related o safety and efficacy
- mitigating costs
- supply chain issues- reverse switching might occur where costs no longer an issue
describe Enbrel and Benepali
Both contain etanercept and are used in the management of moderate-severe RA
Enbrel is the original reference product development by Amgen.
Benepali is the biosimilar product of Etanercept.
describe the rationale fro switching
Biosimilar to biosimilar, or biosimilar to reference drug product:
- Economic considerations (cost, continued access)
Clinical guidelines- formulary decisions
Relocation/travel
To optimize patient benefit (injection site reactions, tolerability issues)
Patient convenience (device differences, frequency of dosing)
Reverse switching (back to originator also happens- less frequent, <10% IBD patients)
Some concerns may be
Changes in effectiveness
Safety profiles
what are barriers to biosimialr switching?
Perceived lack of data/evidence (long-term data, number of patients)
There has been limited extrapolation between biosimilar drug products to-date
Usually rely on RCTs- less powered for elderly, paeds
It takes time to build real-world data
Correlating ADRs with switching to new biosimilar challenging
There is no requirement to cross-compare biosimilars of the same reference biologic
Black triangle drugs (▼) at point of approval- yellow card reporting to build ADR evidence base
what are counselling points on initiation on biologics?
Determine how much information patient already knows- biologic naiive or not
Explain the reasoning for initiation
Explore concerns
Reassure regarding monitoring points
Dosage frequency
Drug-specific points e.g., ADRs, dosage frequency
Vaccines required
Adherence specific comments
Family planning
Consent for blood tests
Conditions specific comments
Storage conditions
Injection technique
Routes of supply- if directly through company vs pharmacy
what are counselling piston when switching biosimilars?
Highlight they both act against the same biological target.
They are both approved for the management of RA.
Both products have gone through rigorous testing.
They would be expected to be very similar in terms of their effectiveness and side effect profile.
The clinician starting therapy would have done this in the patient’s best interest.
If the patient experiences any ADRs to report this to a healthcare professional
what are monitoring requirements fro started a biologics/ biosimilar prefilled pen or injection ?
Monitor for infection before, during and 4 months after treatment
Non-melanoma skin cancer before and after treatment, px with PUVA treatment for psoriasis or extensive immunosuppressant therapy
Patient and carer advice
Seek medical attention if presenting with symptoms of blood disorders (sore throat, fever, bruising, bleeding, etc)
TB- Seek attention if persistent cough, weight loss, fever develop
An alert card should be provided
Effective contraception during treatment (at least 5 months after dose)
Hep B reactivation
Allergic reactions (rare)- Anaphylaxis
Use of other immunosuppressants or biologicals for the management of other immune conditions- polypharmacy risk
what does it mean when pen has a cloudy appearance ?
Precipitation
Aggregation
Causes:
Prolonged storage outside recommended temperature
Dropping/damaging devices
- Excipient incompatibilities- unlikely, can happen for infusion bag
Always refer to label
All solutions for injection should be clear with no cloudiness- always discourage use if visible particles, flakes, discoloration can be seen.
Cost should never be considered, patient safety first
