Transcript PPTX - Pharmaceutical Association of Malaysia

PhAMA Position on Biosimilar
Medicines
Ms. Leah Goodman
Contents
An Overview - Biological Medicines and their Regulatory
Framework
PhAMA Position and Recommendation on Biosimilars
Key Messages
An Overview - Biological Medicines
and their Regulatory Framework
Biological Medicines: An Overview
Biologics differ from generic chemical drugs with respect to their:
Manufacturing processes
Size and complexity
Origin
Composition and nature.
Recombinant technology used to produce biosimilars has:
Turned biologics into important therapeutic options.1
Revolutionized the therapeutic course of intractable diseases such as
cancer,2 diabetes and rheumatoid arthritis.
1. Reichert JM. Trends Biotechnol. 2006;24:293–298.
2. Mellstedt H, et al. Annals of Oncology. 2008;19:411–419.
Biosimilars vs. Generics
Biosimilars
Generics
Manufacturing process
Complex/multifaceted
Simple/straightforward
Size
Large molecules
Small molecules
Origin
Manufactured from genetic
material of living cell cultures or
DNA technologies1
Synthesized in a laboratory
or extracted from natural
sources
Composition & Nature
 Active ingredients are not
identical to the innovator
product
 There is a strong relationship
between the manufacturing
process and the
characteristics of the final
product2
 Active ingredients are
identical to the innovator
product
 The manufacturing
process does not affect
the final product
1. APG, 2011. Procurement and Prescribing Practices for Biologics in the
UK, 29 June 2011.
2. Schellekens H. Nat Rev Drug Discov. 2002;1:457–462.
Regulatory Framework of
Biological Medicines
In Malaysia, the National Pharmaceutical Control Bureau (NPCB) is responsible
for granting marketing authorisations (MA) for biotechnology products.1
Granting of MA for biosimilars is subject to strict regulatory approval, but
assessments of substitution/interchangeability are not inclusive.
NPCB recognised challenges posed by biosimilars for clinical practice:
Safety and efficacy
Pharmacovigilance
Interchangeability and substitution
Market competition
Extrapolation of indications
Comprehensive knowledge of these challenges is crucial to ensure an appropriate place
for biosimilars in the market.2
1. National Pharmaceutical Control Bureau Malaysia. Guidelines on Registration
of Biosimilar. http://portal.bpfk.gov.my/index.cfm?menuid=90&q=biosimlar
2. Suiz and Carlo. The Business Journal for the Generic Medicines Sector. 2011;8:4.
NPCB Guideline on Interchangeability
and Substitution of Biosimilars
“Biosimilars are not generic products and cannot be identical to their reference
products. Further, the formulations may be different and these can have
profound effect on their clinical behaviour. In addition, biosimilars do not
necessarily have the same indications or clinical use as the reference products.
Therefore, given current science, they cannot be considered interchangeable
with the reference product or products of the same class. Automatic substitution
(i.e the practice by which a different product to that specified on the prescription
is dispensed to the patient without the prior informed consent of the treating
physician) and active substance-based prescription cannot apply to biologicals,
including biosimilars. Such an approach ensures that treating physicians can
make informed decisions about treatments is in the interest of patients’ safety.”
1.
Mellstedt H, et al. The Challenge of Biosimilars. Annals of Oncology.
2008;19:411–419.
PhAMA Position and Recommendation
on Biosimilars
PhAMA Position and Recommendation on
Biosimilars
Recommendation
1
All biologic/biosimilar prescriptions should be written by brand name and not by International
Non-proprietary Name (INN).
2
A biologic or biosimilar medicine cannot be considered immediately interchangeable and therefore
not automatically substituted without the knowledge and consent of the treating physician.
3
Patients should be kept fully informed about their medication and should be consulted if changes
to their treatment are made.
4
The summary of medicinal product characteristics (SmPC) should clearly indicate the source of
information contained within it, such as relevant clinical studies or that it has been derived from
evidence about the originator product.
5
Biosimilar medicines should be subject to clinical practice guidelines for the management of all
relevant diseases where biosimilars exist in the treatment armamentarium.
6
Tenders which are undertaken involving biological medicines should not seek to source a single
product only.
7
Extrapolation of indications for biosimilar products should be evaluated on a case by case basis.
All biologic/biosimilar prescriptions should be written by brand name and
not by International Non-proprietary Name (INN).
To facilitate compliance with the patient
safety, and pharmacovigilance identification
and traceability requirements.
To ensure there is no automatic substitution.
To facilitate rigorous, appropriate and
accurate post approval surveillance on the
safety and efficacy of drugs.
To help distinguish between biosimilar
products and reference biologic medicines.
This recommendation is in line with that of EU legislation for Member States,1 WHO,
Australia’s drug regulatory agency, NPCB guidelines,2-4 British National Formulary (BNF),5
European Federation of Pharmaceutical Industries and Associations (EFPIA), and by the
European Biopharmaceutical Enterprises (EBE).
1.Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010
amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community Code relating
to Medicinal Products for Human Use, Article 102e. 2. National Pharmaceutical Control Bureau
Malaysia. 3. Directive 2010/84/EU, Article 102e. 4. MHRA, 2012. Drug Safety Update. 5. British
National Formulary, September 2012.
A biologic or biosimilar medicine cannot be considered immediately
interchangeable and therefore not automatically substituted without the
knowledge and consent of the treating physician.
Drugs with similar pharmacodynamics do not
necessarily ensure the same efficacy and
safety even with simple molecules.1,2
Automatic substitution can impact patient
safety and post marketing surveillance.
No country has declared biosimilars interchangeable with reference products.
France, Germany, and Spain specifically prohibit substitution. Canada does not
support it1 and Japan avoids substitution during post-marketing surveillance.3
1. Rumel D, et al. Revista de Saúde Pública. 2006;40(5):1–7.
2. Furberg CD, et al. Lancet. 1999;354(9185):1202–1204.
3. Bogaert P, et al. Biosimilar regulation: Important Considerations and
Global developments.
Patients should be kept fully informed about their medication and should
be consulted if changes to their treatment are made.
Physician-patient conversations are crucial to
aid a fully informed decision to take a
biosimilar- International Alliance of Patient’s
Organization1
Patient could be fully aware of the
advantages, disadvantages and any adverse
reactions of therapeutic medicine.
Decision to switch medications should never be based on cost alone, the
prescribing physicians must employ appropriate clinical judgment based
on evidence and patient specific therapeutic needs.
1. IAPO. 2013 Briefing Paper on Biological and Biosimilar Medicines, p 23.
http://www.patientsorganizations.org/attach.pl/1763/2086/IAPO%20Brie
fing%20Paper.pdf
The summary of medicinal product characteristics (SmPC) should clearly
indicate the source of information contained within it, such as relevant clinical
studies or that it has been derived from evidence about the originator product.
Source of information in SmPC is crucial as
there have been instances where the
terminology of SmPC sections for a biosimilar
and its originator product were identical.
It is imperative that the SmPC should clearly mention if the information
was obtained from either studies investigating the biosimilar product or
from evidence about the originator product.
Biosimilar medicines should be subject to clinical practice guidelines for
the management of all relevant diseases where biosimilars exist in the
treatment armamentarium.
HCPs need be educated on the integration of
biosimilars into therapy, interchangeability,
automatic substitution, immunogenicity and
monitoring for adverse events.
Educational activities will aid HCPs to
promptly recognise emerging safety issues
and address them through appropriate risk
mitigation strategies.
PhAMA offers to assist MOH to co-design and conduct educational programs on the
appropriate use of biologic medicines. PhAMA strongly encourages medical associations and
Health Authorities to include a section on ‘Biosimilar Safety Considerations in Clinical Practice’
when updating their clinical practice guidelines.
Tenders which are undertaken involving biological medicines should not
seek to source a single product only.
Switching biological medicines between
patients could be challenging as not all
biological medicines may be suitable for all
types of patients.
Choice of medicines needs to be provided to
permit physicians to customise treatment.
PhAMA recommends that tenders must be conducted in a way that is
consistent with the specific regulatory and pharmacovigilance
requirements of biological medicines.
Extrapolation of indications for biosimilar products should be evaluated
on a case by case basis.
For regulatory approval, adequate scientific
justification for extrapolation is needed in
each of the claimed indications, in which,
there is clinical data on the biosimilar itself.
Regulatory approval should further be
supported by post-authorisation monitoring
and pharmacovigilance of the biosimilar.
Appropriate scientific assessment of the comprehensive evidence (analytical, nonclinical and clinical) is needed to determine the acceptability of extrapolation
depending on the type of product, nature of the indications, mechanism of action
and overall weight of evidence.
Key Messages
Key Messages
Despite stringent regulatory framework, there appears to be marked differences
in the perception of the value and use of biosimilars.
PhAMA has thus made 7 recommendations to address challenges posed by
biosimilars for clinical practice.
The recommendations cover areas where action is needed by regulators, HTA
agencies, MOH officials and healthcare professionals who prescribe or
dispense these medicines.
A rigorous implementation of these recommendations by all stakeholders is
paramount to protect patients.
PhAMA Proposal
PhAMA would welcome the opportunity for further dialogue with
regulators, healthcare providers, patient groups and all other interested
stakeholders to contribute to developing a sustainable framework for the
use of biosimilars whilst encouraging scientific innovation, maintaining
standards and patient safety.
Thank You