comparison and regulation

2. BIOLOGICS

3. • biologics generals
• generics drugs differences with Biosimilars
• advantages and disadvantages
• regulatory pathways
• biosimilar
• general concepts
• example of biologics vs Biosimilar
• immunogenicity problem
• post translation modification
• different outcomes with biologics
• price changes

4. BIOLOGICS
• biological products, or biologics, are medical products.
many biologics are made from a variety of natural
sources (human, animal or microorganism). like drugs,
some biologics are intended to treat diseases and
medical conditions. other biologics are used to prevent
or diagnose diseases. examples of biological products
include:

5. BIOLOGICS

7. BIOLOGICS
• list of licensed biological products with:
• reference product exclusivity
• biosimilarity or interchangeability evaluations to date

11. GENERIC DRUGS (OVERVIEW)

12. GENERICS
• a generic drug is a medication that has exactly the same active
ingredient as the brand-name drug and yields the same therapeutic
effect. it is the same in dosing, safety, strength, quality, the way it works,
the way it is taken, and the way it should be used. generic drugs do not
need to contain the same inactive ingredients as the brand name
product.
• however, a generic drug can only be marketed after the brand-name
drug's patent has expired, which may take up to 20 years after the patent
holder’s drug is first filed with the u.s. food and drug administration (fda).
•

13. GENERICS
• generic drugs are usually cheaper than brand name drugs once they reach
the market.
• a drug company develops new drugs as brand-name drugs under patent
protection. this protects their investment in drug research by giving the drug
company the sole right to manufacture and sell the brand-name drug while
the patent is in effect.
• biopharmaceuticals such as monoclonal antibodies they also have generic
versions of themselves, known as biosimilars, are typically regulated under
an extended set of rules.

14. REGULATORY
PATHWAYS OF
GENERIC DRUGS
• generic drug is the same as the brand-
name drug (reference listed drug) in terms
of the following:
• active ingredient;
• dosage form (eg, tablet with tablet, not
capsule with tablet);
• strength (eg, 40 mg referencelisted drug
with 40 mg generic);
• route of administration;
• manufacturedunder the fda’s strict
standards of good manufacturing practice
regulations;

15. GENERIC
• in addition to being pharmaceutically equivalent,
generic drugs must also be
• “bioequivalent” to the brand name drug. • that means the
generic drug will work in the body in the same way and
be as safe and effective as the brand name drug.
• these studies are the same studies brand
manufacturers conduct when they make changes in
their product after approval.

16. BIOSIMILAR
there are two new typesof biological products- biosimilar
and interchangeable.
biosimilars are a type of biological product that are
licensed (approved) by fda because they are highly similar
to an already fda-approved biological product, known as
the biological reference product (reference product), and
have been shown to have no clinically meaningful
differences from the reference product.

17. COMPARISON OF BIOSIMILARS AND BIOLOGICS

19. BIOLOGICALS VS BIOSIMILARS
There are no trials in biosimilar production pathway …. Only regulations

20. ADVANTAGES OF BIOSIMILARS

21. MAJOR CONSIDERATIONS OF BIOSIMILAR
DEVELOPMENT

22. THE EMA DEVELOPMENT AND APPROVAL PATHWAY FOR BIOSIMILARS: A STEPWISE APPROACH TO
DEMONSTRATION OF BIOSIMILARITY BETWEEN A BIOSIMILAR AND THE ORIGINATOR REFERENCE PRODUCT.

23. BIOSIMILAR VS GENERIC
• New Chemical Entities or NCEs
• New Biological Entities or NBEs
• NME relates to the first approvabledrug as opposed to
second indications or new formulations
• “Abbreviated New Drug Application” (ANDA)
• new biologic drug approvals (new BLAs)
• new small molecule drug approvals (NMEs)

24. COMPARISON OF BIOSIMILARS AND GENERICS

25. BIOSIMILARS VS GENERICS

26. BIOSIMILAR VS INTERCHANGEABLE

27. • two of the most important and most difficult
aspects of biosimilar clinical testing are
Bioequivalency (purity and potency) and
Immunogenicity (safety).

28. BIOEQUIVALENCY
Bioequivalence is a term in pharmacokinetics
used to assess the expected in vivo biological
equivalence of two proprietary preparations of
a drug.
if two products are said to be bioequivalent it
means that they would be expected to be, for all
intents and purposes, the same.

29. BIOSIMILARITY
• Biosimilars are not true generics in the sense that they are not exactly the same as the innovator product,
but rather are only considered biologically and clinically comparable to the innovator product.

30. IMMUNOGENICITY
• immunogenicity is the ability of a particular substance, such as an antigen or epitope, to
provoke an immune response in the body of a human or animal. in other words, immunogenicity
is the ability to induce a humoral and/or cell-mediated immune responses.

32. Differentiation has to be made between wanted and
unwanted immunogenicity.
• wanted immunogenicity is typically related with vaccines,
where the injection of an antigen aiming at protecting the
organism. vaccine development is a complex multistep
process, immunogenicity being at the center of the vaccine
efficiency.
• unwanted immunogenicity is an immune response by an
organism against a therapeutic antigen (ex. recombinant
protein, or monoclonal antibody). this reaction leads to
production of anti-drug-antibodies inactivating the
therapeutic effects of the treatment and, in rare cases,
inducing adverse effects.

33. FACTORS INFLUENCING IMMUNOGENICITY IN BIOSIMILARS

34. PATIENT-DISEASE related
• genetic factors
• disease
• activated immune systems due to chronic infections,
allergies and autoimmune diseases
• age
• age-dependent maturation of the immune system
observed in children,
• potentially altered immune response in the elderly

35. PRODUCT RELATED
• interactions between proteins and excipients, and impurities
from the manufacturing process
• packaging may trigger immune responses
• Mollecule design
• major modification of the therapeutic protein by
• glycosylation,
• pegylation
• formation of fusion proteins

36. POST TRANSLATION MODIFICATION
• post-translational modification (PTM)
refers to the covalent and generally
enzymatic modification of proteins
during or after protein biosynthesis.
proteins are synthesized by ribosomes
translating mRNA into polypeptide chains,
which may then undergo PTM to form the
mature protein product.
• Biosimilars also go under PTM duo the
fact the are mostly proteins which may
lead to different outcomes clinically

37. BIOSIMILAR COMPETITION HAS
LED TO CONSISTENT PRICE
REDUCTION IN EUROPE
• 1. Biosimilars reduced the average list prices for
the whole product class in European countries.
• 2. lower reference product pricing lowered
biosimilar market penetration.
• 3. in therapeutic classeswith multiple biosimilar
competitors, the first biosimilar to market
typically has the highest biosimilar market share
• 4. biosimilar competition increased consumption
of drug products across several therapeutic.

38. CONCLUSION
• biosimilars just like generics are a way to a better health care system where almost every
human being can benefit from them biologics
• cost efficiency can not be denied
• more development companies can work and that means future

40. QUESTIONS
• 1: WHAT ARE BIOSIMILARS?
• 2: WHAT'S THE DIFFERENCE BETWEEN BIOSIMILARS AND BIOLOGICS ?
• 3: DIFFERENCE BETWEEN GENERICS AND BIOSIMILARS?
• 4: WHAT IN POST TRANSLATION MODIFICATION?
• 5: WHAT IS WANTED IMMUNOGENICITY?