This document discusses the regulatory process for biologics in the United States and Europe. It provides information on the sources and types of biologics, as well as the differences between biologics and chemical drugs. It also describes the regulatory authorities, approval processes, and requirements for a Biological License Application in the US. Finally, it compares the US and European guidelines regarding preclinical studies and requirements for approval of biologics.

1. Presented By,
ASHUTOSH PANDEY
M.Pharm
PSIT

2.  INTRODUCTION
 SOURCES AND TYPES OF BIOLOGICS
 DIFFERENCES BETWEEN BIOLOGICS AND
CHEMICAL DRUGS
 REGULATORY AUTHORITY FOR BIOLOGICS
 DEVELOPMENT AND APPROVAL PROCESS
 BIOLOGICAL LICENSE APPLICATION (BLA)
 COMPARISON BETWEEN US AND EUROPIAN
GUIDELINES REGARDING BIOLOGICS
 CONCLUSION
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3.  Biologics are the products manufactured, extracted from
or semi synthesized from a biological source which are
regulated by FDA(Food And Drug Administration) and are
used to prevent cure and treat diseases and medical
conditions.
 These are generally large, complex molecules produced
through biotechnology in a living system such as a
microorganism, plant cell or animal cell.
 These could be made of sugars, proteins, nucleic acids or
complex combinations of these substances or may be living
entities.
 These are complex mixtures that are not easily identifiable
and characterized these tend to be heat sensitive and
susceptible to microbial contamination hence, it is
necessary to use aseptic principles from initial
manufacturing process.
 EXAMPLES: Botox, Herceptin, Vaccines, Enbrel
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4. SOURCES
Mammalian cell culture
Bacteria
Insect cell culture
Plant cell culture
Yeast
Transgenics
Avian cell culture
Humans
TYPES
Blood derivatives
Vaccines
Allergenic extracts
Whole blood
Blood components
Proteins
Human tissues
Cellular and gene therapies
Xenotransplantation products
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5. PROPERTIES BIOLOGICS CHEMICAL DRUGS
SIZE Large Small
STRUCTURE Complex Simple
STABILITY Unstable Stable
MODIFICATION Many options Well defined
MANUFACTURING Impossible to ensure
identical copy
Identical copy can
be made
CHARCTERIZATION Impossible to
characterize
Easy to characterize
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6.  Center for biologics evolution and research (CBER) is the center
within FDA that regulates biological products for human use
under applicable Federal laws including the Public Health
Services Act (PHS) and the Federal, Food, Drug and Cosmetics Act
 CBER protects and advances the public health by ensuring that
biological products are safe and effective.
 FDA's regulatory authority for the approval of biologics resides in
(PHS) Act. Biologics are subjected to regulation under Federal,
Food, Drug And Cosmetics act (FD&C) Act.
 Some medical devices which are used to produce biologics are
regulated by CBER under FD&C Act's medical device amendments
of 1976.
 FDA also reviews new biological products and new indications
and usage for already approved products on the market for the
treatment of known diseases.
 It protects against threats of emerging infectious diseases.
 It provides the public with information to promote safe and
appropriate use.
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7.  Advertising and Labeling
 Investigational New Drug Application (IND)
or Device exemption process (IDE)
 Expanded Access
 Premarket Approval (PMA)
 Biologics License Application (BLA)
 New Drug Application Process (NDA)
 Biologics Approvals By Year
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8.  The Biologics License Application (BLA) is a request for
permission introduce or deliver for introduction a Biologic
product into the market
 It is mainly regulated by 21 CFR 600-800. It is submitted by
any legal person or entity who engaged in manufacture or
an applicant for a license who takes responsibility for
compliance with product and establishment of standards.
 A Biologic License application generally applies to vaccines
and other Allergenic drug products and cellular and genetic
therapies.
 Form 356h specifies the requirements for a BLA . It mainly
includes the following:
1. Applicant information
2. Product / manufacturing information
3. Pre clinical studies
4. Labeling
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9.  Applicants must submit the form356h to the
CBER and Await for the review of FDA.
 FDA receives the BLA and reviews it if the
manufacturers produce inappropriate
information then it issues a letter called
Refuse To File(RTF) .
 If FDA approves the BLA they will issue a
approval letter which authorizes the
manufacturer to distribute the product.
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11. UNITED STATES EUROPE
REGULATORY BODY Food And
Administration (FDA)
FDA adopted the S6
Guidance
European Medicines
Evaluation
Agency (EMEA)
CHMP has adopted ICH
S6 guideline
APPROVAL STANDARD Biological License
Application
Marketing
Authorization
Application
PRECLINICAL STUDIES
SPECIES SELECTION
IMMUNOGENICITY
Chimpanzee
Elicit immune response
Rodent and Non Rodent
species
Sponsor should
measure ADA'S
STUDY DESIGN Pharmacodynamic
studies
Pharmacokinetic and
Pharmacodynamic
studies
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12.  The study introduces the legal and regulatory
aspects pertaining to biologics in the united
states and European union.
 The Drug approvals in the US, Europe are the
most demanding in the world .
 The main objective of the rules governing
medicinal products in US , Europe is to safe
guard the public health
 It is the role of regulatory authorities to
ensure that pharmaceutical companies shall
comply with regulations mentioned above .
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