Biologic Drugs Flashcards
What are biotech drugs?
A medication derived from a living organism or their cells
Larger and more complex than traditional pharmaceutical products
How is the synthesis of biologics similar to small molecule pharmacueticals?
Biologics are is produced from genetically engineered living organisms or cells
Small molecule pharmaceuticals are formed through chemical synthesis
Is the molecular structure of biologics fully known?
No, it is complex and frequently partiallly unknown
What is the risk of contamination of biologics during manufacturing?
Higher compared to small molecule pharmaceuticals
Are biologics more resistant to physical factors compared to small molcule pharmaceuticals?
No, biologics are less resistant to physical factors
What are some relative ADME properties associated with biologics compared to small molecule pharmaceuticals?
Absorption (Slower)
Distribution (Low/Limited)
Metabolism (Catabolized to endogenous amino acids)
Excretion (target-mediated)
What additional information do biologics manufacturers have to provide Health Canada for drug approval compared to small molecule pharmaceuticals when seeking approval?
Must include more detailed chemostry and manufacturing information (this done to confirm the purity and quality of the product)
What are the six types of biologic products used in pharmacotherapy?
- Blood and blood components
- Proteins
- Human Tissues
- Vaccines
- Allergenic Extracts
- Cellular & Gene Therapies
What are some commonly used biologics?
Insulin
Botox
Infliximab (Remicade)
What is the place of monoclonal antibodies in COVID-19 treatment?
Used in early treatment in mild-moderate COVID-19 illness in at-risk patients
They will bind to healthy cells, preventing viral insertion into healthy cells
ex. Evusheild & Regeneron
Is spending on biologic drugs decreasing over time?
No, the proportion and magnitude of drug spending on biologics is increasing.
ex. In 2020 ($278bil/year) vs. 2023 ($465bil/year)
Do biologics make up more than 30% of new drug approvals by the FDA?
Yes, and the proportion increases every year
2022 (40.5% of drug approvals were for biologics)
Are the most innovative drugs released in Canada at the same time as the United States?
No, only 1/3 of drugs new approved drugs (from 2016 to 2020) in the USA and Europe were approved in Canada
What is the most common indication for biologics?
Neoplasms and Cancer therapies are the most common indication for biologic treatments
What biologic product saw the greatest sales in 2022?
Comirnaty (BioNTech/Pfizer) was 1st, with over $40 billion in sales
COVID-19 vaccine
The Moderna vaccine was 2nd place
Why are biologics so expensive?
- Manfacturing costs
- R&D costs
- Competition (free market and benchmark pricing)
- Many biologics target rare diseases, so the market for them is small (economies of scale)
What is the function of intellectual property rights for drug manufacturers?
They provide market exclusivity (competing firms cannot use clinical trial data to formulate a generic version immediately)
This helps innovative firm to recuperate drug development costs and generate profit (incentivises drug manufactures to conduct difficult and expensive R&D, especially for biologics)
What is a biosimilar?
A “copy” of a commercially availavle biopharmaceutical (reference product) that no longer has patent protection
This “copy” must satisfy the following requirements:
- Rigourous analytical and clinical assessment in comparison to reference product
- Approved by regulatory agency according to a biosimilar evaluation pathway
Are biosimilars priced at significant discounts compared to their reference products?
Yes, but the discounts are not as significant (25-50% off compared to brand) compared to generic drugs (50-90% discount) for small molecule pharmaceutics
This is because the process of showing bioequivalence of a biosimilar to a reference product, costs a alot more compared to getting a generic drug approved
What types of evidence needs to be given to Health Canada for approval of biosimilar?
Totality of evidence (final determination of similarity is based on the etire submission, including data derived from comparative structural, functional, non-clinical and clinical studies”
Quality: chemistry and maufacturing (must use the same amino acid sequence)
Non-clinical: pharmacology and toxicology
Clinical: pharmacology, safety, and efficacy
Are biosimilars expected to be completely identical to the reference product?
No, minor differences between the reference product and the proposes biosimilar product in clincally inactive components are acceptable
What are some parameters that should be the same between reference product and proposed biosimilar?
- Dosage form
- Strength
- Route of administration
Is post-marketing required for biosimilars?
Yes, post-marketing is mandatory (looks for issues with biosimilar not caught in the clinical trials and approval process at large)
What jurisdiction decides whether a given biosimilar is interchangeable with a reference product?
The provincial authorites pertaining to the regulation of pharmacy
