Classification of Biological Products

Development and Regulatory
Status of Biosimilar Product:
Brazil
Marcelo Moreira
Brazilian Health Surveillance – ANVISA
Seoul, July, 10 2014
Development of Biological Products Regulation
Law 6360/1976 – general regulation about medicines,
including biological products
RDC 80/2002 – first regulatory act specific for
biological products. Same approach for new products
and copies
RDC 315/2005 – second regulation regarding
biological products. Same approach for new products
and copies, with more detailed informations
RDC 55/2010 – current regulation. Specific approach
for copies of biologicals
Biological Products licensed in Brazil
Vaccines;
Hiperimmune sera;
Blood products;
Biomedicines:
medicines obtained from biological fluids or animal
tissues;
medicines from biotechonological procedures.
Monoclonal antibodies;
Medicines containing live, attenuated or dead
microorganims;
Probiotics;
Alergens.
Regulatory acts concerning biological products
RDC 47/09 e 60/12
Package insert
RDC 71/09, RDC 168/02
RDC 61/12
Label
RDC 81/08
Import
Lei 6360/76
Dec. 8.077/13
RDC 55/10
Registration
RDC 49/11 e 24/13
Post-approval
RDC 46/00
Blood products
RDC 233/05
Allergenics
RDC 323/03
Probiotics
RDC 50/11 e 25/13
Stability
RDC 234/05
RDC 38/10
Quality control
RDC 17/10
Good Manufacturing
Practices
Portaria 174/96
Antivenom serums
Classification of Biological Products
I – Biological product: is the biological drug that is not
new or is known, containing molecule with known
biological activity, already licensed in Brazil and that has
undergone all stages of manufacturing
RDC 55/2010
Classification of Biological Products
II – New Biological Product: is the biological product
containing molecule with known biological activity, not
yet licensed in Brazil and that has undergone all stages of
manufacturing
RDC 55/2010
Classification of Biological Products
III – Comparator Biological Product: is the biological
product already licensed by Anvisa based on submission
of a full dossier and that has already been sold in Brazil
RDC 55/2010
Classification of Biological Products
New
Biological
Product
• not yet licensed in Brazil
Biological
Product
• already licensed in Brazil
Regulatory Pathways
New biological
product
Biological product
Individual route
of development
Complete
dossier
Complete
dossier
Comparative
Phase III
Non innovative
biological product
9
Comparability
development
Comparability
exercise
Quality, Safety,
Efficacy
Biosimilar
Individual Development Pathway
It is the regulatory route that can be used to license a
biological product, in which it’s necessary to present full
data on the development, production, quality control and
nonclinical & clinical data to demonstrate the quality,
efficacy and safety of the product
Individual Development Pathway
Production and quality control data must meet the
quality standards already established for the product to
be licensed
The extent of the nonclinical studies may be reduced,
considering factors like molecule complexity, level of
structure characterization, extent of characterization of
the product’s level of impurity, mechanism of action of
molecule, toxicity potential and therapeutic index
Individual Development Pathway
The extrapolation of indications is not applicable for
biological products licensed by the individual
development pathway
Phase I and II clinical trials are not necessarily
comparative
Individual Development Pathway
Phase III studies will be always necessary and must be
comparative to new biological product
When available, phase IV studies must be presented
Comparability Development Pathway
It is the regulatory route that can be used to license a
biological product, in which the comparability exercise in
terms of quality, efficacy and safety was used between
the developed product and the comparator biological
product
Comparability Development Pathway
The same comparator must be used in all stages of the
comparability exercise
If the comparator biological product is not available in
the national market, the same product can be purchased
in international market
Comparability Development Pathway
Non clinical and clinical data can be reduced
Extrapolation of safety and efficacy data for other
therapeutic indications of the biological product licensed
through the comparability development pathway will be
established through specific guides
Comparability Development Pathway
Requirements for extrapolation of data
A sensitive test model has to be used, which has to be
able to detect potential differences between the
biosimilar and the comparator
The mechanism of action and/or involved receptor(s)
must be the same
Safety and immunogenicity have to be sufficiently
characterized
General Considerations
Clinical trials must be conducted with biological
product submitted to registration
Clinical trials must be approved by National Regulatory
Authority in which country clinical trial was carried on
All clinical trials conducted in Brazil must have previous
authorization of Anvisa
General Considerations
The clinical trials reports must follow the document
called “Guide for elaboration of clinical trials report to
registration and post-registration changes of biological
products”
For both pathways is mandatory to present:
immunogenicity study report;
risk management plan;
pharmacosurveillance plan.
Guidelines
Comparability
exercise Guideline
http://s.anvisa.gov.br/wps/s/r/lg
Guidelines
Heparin Guideline
http://s.anvisa.gov.br/wps/s/r/lg
Guidelines
Interferon Alpha
Guideline
http://s.anvisa.gov.br/wps/s/r/lg
Guidelines
Guideline for
elaboration of Clinical
Study Reports
http://s.anvisa.gov.br/wps/s/r/lg
Thank you!
Web Site: http://www.anvisa.gov.br
Call Center:
0800 642 9782.
Free call from any state of Brazil.
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to Friday, except holidays.
Contact us:
http://www.anvisa.gov.br/institucional/fal
econosco/FaleConosco.asp
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visa/ouvidoria
Twitter: @anvisa_oficial
E-mail: [email protected]
Phone number: + 55 (61) 3462 55 91

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