Biologics and Biosimilars Flashcards
what is a biologic
A medication derived from a living organism or their cells
Larger and more complex then traditional pharmaceutical products
How do regulations regarding biologics differ
Biologics differ from other drugs for human use in that they must include more detailed chemistry and manufacturing information compared to other drugs (ensures it isnt contaminated by an undesired microorganism or another biologic)
An inspection of the manufacturing facility, known as an On-Site Evaluation (OSE) is also completed to assess the production process and facility
Biologics are then monitored by being placed on a lot release schedule tailored to their potential risk, manufacturing, testing, and inspection history to date
what are some types of biologics?
Blood and blood components Proteins Human tissues Vaccines Allergenic extracts Cellular and gene therapies
when was the first biologic developed?
First biologic (rDNA insulin) in 1982
who are the major players in biotech?
- AbbVie
- Gilead
- Genentech
- Amgen
- Bayer
where is the biologic space at today?
- May see a boost in those companies invested in COVID-19 Developments
- 5 out of 10 top drugs are in the oncology space
- Keytruda (pembroluzimab) may hit $26 billion/year by 2025
why are biologics so important?
Biologics hold great promise for providing a lower cost treatment option for chronic disease
why are biologics so expensive
- Manufacturing costs
- Research and development costs
- Competition (free market and benchmark pricing)
- Many biologics target rare diseases, so the market for them is so small
what are intellectual property rights
Period of time following marketing approval during which competing firms may not use the innovative firms clinical trial date in order to obtain marketing authroization for a generic version
what are the benefits or intellectual property rights
Data exclusivity grants the innovative firm a period of protection for their investment in clinical trials and data collection
Gives incentives to invest in the difficult and expensive research and development necessary for biologics advances
what are some future issues for biologics
- 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
- In CAN, prevalence of off-label use is estimated at 11%, and of off-labels prescriptions, 79% lacked strong scientific evidence
what is a biosimilar
A biosimilar is a copy of a commercially available biopharmaceutical (reference product) that no longer is protected by patent which has:
Undergone rigorous analytical and clinical assessment, in comparison to its reference product
AND
Been approved by a regulatory agency according to a specific pathway for biosimilar evaluation
why is it called a biosimilar and not a generic?
A biosimilar is “highly similar” to its reference product in physiochemical characteristics, efficacy, and safety
HC approval of a biosimilar is not a declaration of pharmaceutical equivalence, bioequivalence or clinical equivalence to the reference biologic drug
Cannot say they are exact
why are biosimilars important?
Additional treatment choices at a lower cost
Increased access to biologics, which may lead to improved health outcomes overall
why have biosimilars created a new market?
Bringing a biosimilar to market will be more costly and less certain than producing a generic drug
Wont see anymore than 3-4 biosimilars come on the market, shares the wealth but doesn’t dilute the market so much that it reduces the drug cost too far
To have a biosimilar approved do you have to prove bioequivalence?
NO
Must conduct at least 1 clinical trial for toxicity, immunogenicity, PK, and analytical studies
what does it mean by saying biosimilars are “highly similar” to biologics
Minor differences between the references product and the proposed biosimilar product in clinically inactive components are acceptable
what are the regulations regarding biosimilar approval?
Although submission is rigorous and based on RCTs, a reduced non-clinical and clinical package vs. the innovator
The dosage forms, strengths, and routes of administration of the biosimilar should be the same as that of the reference biologic Post-marketing safety programs (Phase 4: real-world effectiveness) must also be in place
Authorization of a biosimilar is not a declaration of interchangeability nor substitutability
who determines if biosimilars and biologics are interchangeable?
It’s the provinces who decide if the biosimilar and innovator may be interchangeable
can information about biosimilars be extrapolated to other indications where clinical studies HAVE NOT been done?
YES, Clinical studies don’t need to be performed for each indication
what is switching?
Switching refers to a one-time change from a reference biologic drug to a biosimilar
Health CAN recommends that a decision to switch a patient being treated with a reference biologic drug to a biosimilar should be made by the treating physician in consultation with the patients and taking into account available clinical evidence and any policies of the relevant jurisdiction
What are Pros for switching
Efficacy and safety data generally showed no differences between patients who switched treatments vs. those who did no
Switching doesn’t appear to be associate with any major efficacy, safety, or immunogenicity issues
what are Cons for switching
Immunogenicity: Biologics injected into the body: the immune system will often react
To be approved, biosimilars must show no clinically meaningful differences in immunogenicity, and it must be monitored after approval however, immunogenicity can range from not-clinically significant to eliciting an immune response which can effect safety and efficacy
some physicians feel switching isnt in their patients best interest
what is the overall verdict on switching
- For treatment naïve patients, its generally supported that one can start on a biosimilar
- For non-naïve patients, most regulatory bodies have said switching to a biosimilar can be done safely
- Some physicians and patients arent in favor of non-medical switching
- Will better know the long-term impact in a few years time with more research and experience
what are the challenges for public payers surrounding biosimilars
Biosimilar market dynamics are different than oral generics
Health CAN approves these, currently no interchangeability framework
Biosimilar manufacturers: less experienced and fragmented (generic and brand players)
Must listen to desires of prescribers and patients
Patient indications
Infusion costs/infrastructure
what are patient perceptions on biosimilars?
75-80% believed biosimilars are different and will have different adverse events than the originator
80% say you shouldn’t recommend switching
Healthcare providers were least frequent source of information
what are physician perspectives on biosimilars
45% felt them to be safe and appropriate (despite the fact that most trust the FDA approval process)
Physician experience and comfort with brand
Patient outcomes is of prime importance
Concerns for biosimilars vary by therapeutic area
Manufacturer experience with biologic production is meaningful
how will pharmacists be involved in the switching to biosimilars?
Communication with prescribers
Informing the patient what a biosimilar is
Pharmacists have a responsibility to inform patients about available treatment options, including lower-cost alternatives such as biosimilars
Close relationships with prescribers will be important
Pharmacists should report Aes
