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PHAR224 > Biosimilars > Flashcards

Biosimilars Flashcards

1
Q

What are biotech drugs?

A

a medication derived from a living organism or their cells

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2
Q

How are biotech drugs produced?

A

biotechnology
-technology that harnesses living organisms and biomolecular processes to develop fight diseases

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3
Q

True or false: biotech drugs are smaller and less complex than traditional pharmaceutical products

A

false
biotech drugs are larger and more complex

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4
Q

What are the steps in manufacturing of biological products?

A
  1. host cell development
  2. master cell bank establishment
  3. protein production
  4. protein purification
  5. analysis
  6. formulation
  7. storage & handling
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5
Q

Differentiate biologics and small molecule pharmaceuticals based on the following:
-method of synthesis
-molecular size
-structure
-susceptibility to contamination
-molecular structures
-complexity
-sensitivity to physical factors

A

method of synthesis
-small molecule: chemical synthesis
-biologics: genetically engineering cells/organisms
molecular size
-small molecule: small
-biologics: large
structure
-small molecule: usually fully known
-biologics: complex, frequently partially unknown
susceptibility to contamination
-small molecule: low
-biologics: high
molecular structure
-small molecule: relatively simple
-biologics: complex spatial structures
complexity
-small molecule: relatively pure ingredients
-biologics: complex ingredients
sensitivity to physical factors
-small molecule: low
-biologics: higher

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6
Q

Differentiate biologics and small molecule pharmaceuticals based on the following:
-clinical behavior
-manufacturing process
-species
-immunogenicity
-ADME
-PK profile
-half life
-safety

A

clinical behavior
-small molecule: well understood MOA
-biologics: complicated MOA, not always understood
manufacturing process
-small molecule: straightforward
-biologics: highly complex
species
-small molecule: interdependent
-biologics: specific
immunogenicity:
-small molecule: non antigenic (generally)
-biologics: antigenic
ADME
-small molecule: faster absorption, higher distribution, metabolized to non-active and active metabolites, excretion rarely target-mediated
-biologics: slower absorption, distribution low, catabolized to endogenous amino acids, excretion often target-mediated
PK profile
-small molecule: frequently linear
-biologics: usually non-linear
half-life
-small molecule: short(er)
-biologics: long
sagety
-small molecule: toxicity (variable mechanisms)
-biologics: exaggerated pharmacology

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7
Q

Provide some points regarding the regulation of biologics.

A

before consideration for approval there must evidence to show safety, efficacy, and quality
must include more detailed chemistry and manufacturing information (differs from other drugs)
-important for purity
as part of NDS process, the manufactures must supply Product Specific Facility Information
On-Site Evaluation (OSE) assess production process and facility
if evidence supports product the product is issued a NOC and DIN
products are carefully scrutinized before they are placed in any lvl of the lot release process
Health Canada monitors AE, complaints, and reports (post approval surveillance)

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8
Q

What are some types of biologics?

A

blood and blood components
proteins
human tissues
vaccines
allergenic extracts
cellular & gene therapies

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9
Q

Provide a brief history of biologics.

A

1982: first biologic (rDNA insulin)
between 1996-2007: 136 biologics FDA approved
today: >350 commerically available

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10
Q

Which type of biologic accounts for a huge portion of available biologics?

A

monoclonal antibodies
-direct attack on site

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11
Q

What is the top target for monoclonal antibodies?

A

oncology
-PD1/PDL1

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12
Q

Describe monoclonal antibodies for COVID-19.

A

used in early treatment of mild-moderate COVID-19 illness in at risk patients
provide an immune response (act like natural antibodies)
examples:
-regeneron
-bamlanivimab
-etesevimab
-sotrovimab
-evushield

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13
Q

Are the estimates for cost of biologics fairly correct?

A

history tells us that predictions are vastly underestimated

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14
Q

Who is the top pharma company by revenue as of 2022?

A

Pfizer ($100 billion)
-vaccine is a big reason

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15
Q

What are the steps in the biopharmaceutical research and development process?

A

basic research
drug discovery
pre-clinical
clinical trials
-phase 1, phase 2, phase 3
FDA review
post-approval research & monitoring
-phase 4

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16
Q

What are some reasons that less new drugs are launched in Canada compared to countries like that USA and European countries?

A

difference in market size
didnt do well in those markets
lots of “me too” drugs

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17
Q

Which indication sees the largest number of biotech products?

A

oncology

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18
Q

Why are biologics so expensive?

A

manufacturing costs
R&D costs
competition (free market and benchmark pricing)
many target rare diseases=small market

19
Q

What are intellectual property rights?

A

provides market exclusivity
-period of time during which competing firms may not use the innovative firms clinical trial data to obtain marketing authorization for a generic version
gives incentives to invest in the difficult and expensive R&D necessary for biologics advances

20
Q

What are some future issues for biologics?

A

market exclusivity will erode as patents expire and competing products enter the market
revenues generated by biologics are threatened by increasing scrutiny from government health agencies and other payers

21
Q

What is a biosimilar?

A

a “copy” of a commercially available biopharmaceutical (refence product) that no longer is protected by patent
-has undergone rigorous analytical and clinical assessment in comparison to the reference product
-approved by a regulatory agency according to a specific pathway for biosimilar evaluation
highly similar to its reference product in PC, efficacy, and safety

22
Q

True or false: Health Canada approval of a biosimilar is a declaration of pharmaceutical equivalence, bioequivalence or clinical equivalence to its reference biologic drug

A

false

23
Q

What are the potential benefits of biosimilars?

A

additional treatment choices at a lower cost
increased access to biologics, which may lead to improved health outcomes overall

24
Q

Describe the difference in bringing a biosimilar to market compared to a generic drug.

A

bringing a biosimilar to market is more costly and less certain than producing a generic drug
-generic: 3yrs, $1-2 million, gain ~90% of market in 1yr
-biosimilar: 5.5-7.5yrs, $10-40 million, market share uncertain

25
Q

Differentiate between generics and biosimilars based on the following criteria:
-molecular complexity/manufacturing
-immunogenicity
-approval
-same generic name
-indications
-interchangeability
-price discounts

A

molecular complexity/manufacturing:
-generics: simple products via chemical means, made same as brand name
-biosimilars: complex products by living cells, may vary in purification from brand
immunogenicity:
-generics: none
-biosimilars: yes
approval:
-generics: must show bioequivalence
-biosimilars: at least 1 clinical trial for toxicity, immunogenicity, PK, analytical studies
same generic name:
-generics: yes
-biosimilars: no, may have different
indications:
-generics: same as brand
-biosimilars: may or may not have same as brand
interchangeability:
-generics: yes
-biosimilars: not automatically
price discounts:
-generics: 50-90% of brand
-biosimilars: 25-50% of brand

26
Q

Where does the difference lie in developmental pathways when comparing biologics to biosimilars?

A

biologics:
-focused on clinical studies
biosimilars: pyramid is inverted
-focused on analytical studies

27
Q

Describe the approval process for biosimilars.

A

comparative evidence to the innovator must be provided to HC
totality of evidence:
-similarity based on entire submission, including data derived from comparative structural, functional, non-clinical and clinical studies
quality:
-chemistry and manufacturing; must use same aa sequence
non-clinical:
-pharmacology and toxicology
clinical:
-pharmacology, safety, efficacy

28
Q

What does it mean to be highly similar?

A

minor differences between the reference product and the proposed biosimilar product in clinically inactive components are acceptable

29
Q

Who decides if a biosimilar and innovator may be interchangeable?

A

the provinces
-authorization of a biosimilar is not declaration of interchangeability nor substitutability

30
Q

What kind of monitoring occurs once a biosimilar has hit the market?

A

post-marketing safety programs (phase 4)

31
Q

True or false: the dosage form, strength, and route of administration of the biosimilar should be the same as that of the reference biologic

A

true

32
Q

What can be done with information about a biosimilar after it has hit the market?

A

information can be extrapolated to other indications where clinical studies not done

33
Q

What are some key aspects that may be considered for extrapolation of a biosimilar for new indications?

A

MOA in each condition
PK and biodistribution
expected toxicities
any other factor

34
Q

Differentiate between generics and biosimilars based on interchangeability and substitution.

A

generics:
-regulatory or payer agencies may designate the two as interchangeable
-pharmacists may be authorized/required to substitute a generic for the original without informing the physician
biosimilars:
-biosimilarity status by a regulator does not imply interchangeability

35
Q

Which continent has the most amount of approved biosimilars?

A

Europe
-Canada has less than Europe and the US

36
Q

What are some reasons for the low uptake of biosimilars?

A

lack of pharmacy awareness and not carrying them
lack of prescriber awareness
not first to market=not first to mind
patient and physician reluctancy to change

37
Q

As of 2018, when a generic is available, they are used ___ of the time. When a biosimilar is available, they accounted for ___ of biologic spending.

A

90.3%
9.1%

38
Q

Which province was the first to introduce the Biosimilars Initiative?

A

BC

39
Q

What have the effects of the Biosimilar Initiative been in BC?

A

prompted private plans to copy the governments switching policy
in Dec 2021, private drug plan biosimilars share of the total eligible amount for biologics with biosimilar options was 65% in BC, compared to 12% in the rest of Canada

40
Q

Are biosimilars safe and effective?

A

they undergo testing in clinical trials similar to innovators
some data relies on the innovator but it is a rigorous approval process
shows that the 2 medicines are highly similar
any difference between the 2 medicines should have no impact on safety or efficacy

41
Q

Are biosimilars interchangeable?

A

no

42
Q

What is the nocebo effect?

A

a patients negative expectations affect the treatment outcomes

43
Q

How can we help combat the nocebo effect?

A

acknowledge it; empathy
speak face to face
be informed and provide information
promote a neutral or positive outlook

PHAR224 (7 decks)

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