business of generics Flashcards
federal government: responsibilities
❑ HEALTH CANADA - review and approval of Rx (branded/ethical) and Gx (generic) pharmaceutical products
❑ International trade agreements (eg WTO, NAFTA –USMCA; CETA)
❑ Intellectual property regime (Patent Act, Patent regulations)
❑ CANADA HEALTH ACT
provincial governments: responsibilities
❑ Delivery of health care including drug programs
❑ Significant variance in inter-provincial listings, coverage, fees.
what is the generic pharmaceuticals reality aka what is the interplay
science, economics, law
Health Spending in Canada 2022
Total spend $331 Billion
➢ Annual Growth 4%
what are the top e spending categories
➢ 1. Hospitals (24.34%)
➢ 2. Physicians (13.60%)
➢ 3. Drugs (13.58%) (2% are
generic drugs)
Healthcare as % of GDP
➢ - 12.2% 2022
➢ - 13.8% 2020 (COVID)
in 2022, generic medecines were dispensed to fill…. of all prescriptions in canada
74.4%
-saved governments, employers and patients more than 37 billion$
what are the reasons of the rising healthcare costs
❑ Prescription drug coverage not part of Canada Health Act –
changes can be made more easily (delisting, co-payment
/fees, deductibles, etc.) but not politically popular
❑ Cost-benefit ratio: quality of life, hospitalisation
❑ In-patient ➔ out-patient costs
more than 60% of public money is used for.. of canadians
12% of canadians, each of whom has 2500$ worth of prescription drugs paid for by public programs
Pricing & Reimbursement: Who Pays?
- Health Canada deems products bioequivalent
- Provincial Ministries of Health designate as interchangeable (substitutable).
- In BC, QC, NB, PEI decision at discretion of College of Pharmacy
how expensive is insulin in the us
98$
New US Bill capping
insulin at 35$ applies
ONLY to
medicare patients
Brand Drug Pricing
❑ Patented Medicines Price Review Board (Federal) Controlled
❑ Comparator Countries –
❑ PMPRB09: France, Germany, Italy, Sweden, Switzerland, UK and USA
❑ PMPRB11: Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden and the United Kingdom
Generic Drug Pricing
❑ Provincially Controlled
❑ Comparator - Brand
Drug pricing in Canada applies to ….
all regardless of payer
generic industry: jobs
10 000 in canada while the brands is 15 000
generic industry: innovation
❑ $615-million + annually on R&D (focus is Development)
❑ More than 100 products in development
generic industry: exportations
❑ Exports: 40% of sales volume through export to 120
countries
generic industry: manifacturing
Manufacturing: Vast majority of generic pharmaceuticals
sold in Canada are produced domestically (drug products not drug
substances)
lessons learned from covid 19: manifacturing
Insufficient domestic manufacturing left Canada at the mercy
of other countries to access drugs manufactured in foreign
plants. US implemented an emergency law that prohibited
Pfizer and Moderna from exporting the vaccine until US needs
were first met.
Market Trends Favour Generics & Biosimilars
❑Growing demand for medicines –
demographics, lifestyle, aging population
❑Rapid emerging market growth
❑Increasing access to health care
❑Unremitting cost pressures from public and
private payers
❑Increasing acceptance and penetration
❑Stable flow of patent expiries
Drug development comparison
-New Medicine (including cost of failures) Development time >10 years Cost $1-3 Billion
-Biosimilar (cost of failures n/a low attrition) Development time ~ 5 to 9 years Cost $> 100 million
-Small-Molecule Generic Development time ~ 2 years
Cost $~ 2 million
generics requirement is for what?
bioequivalence
Generic Development & Regulatory Approval
-formulation: same quality of ingredients
-bioequivalence: adme profiles must have equivalent pk
-same standards: all manifacturers have the same standards
2-way crossover double-blinded PK
❑ Inter and intra subject drug equivalence of brand vs generic
❑ Statistically similar to lot-to-lot variation of brand
Evaluation of Patent Landscape
❑ Scope of protection,
❑ Expiry of patents,
❑ Degree of development freedom
❑ Assessment of non-infringement potential
❑ Evaluation of patent validity for « blocking » patents
❑ Litigation costs vs value of the market
Gx must submit notice to …
brand that they have submitted to Health Canada for approval AND state if they are challenging the patent.
Brand company will initiate court proceedings which starts an …
automatic 24 month stay.
Health Canada cannot approve a generic until a court decision is rendered or the 24 month
stay expires
The arrival of generics led to a proliferation of patents assigned
to branded companies
covering multi-functional aspects of drug discovery and development; delay entry of generic
Symbiotic relationship between generics and brands
❑ Generics provide Brands impetus to innovate
❑ Brand innovation provides a healthy gx pipeline
R&D-based firms require annual sales potential greater than….
$200 million to develop an NCE
BIOSIMILAR COMPANIES - BLURRED LINES
❑ Traditional Generic Companies : Sandoz inc; Teva Pharmaceutical Industries Ld.;
Apotex Inc.; Mylan N.V.; Fresenius KabiAG; Intas Pharmaceuticals Ltd.; Dr Reddy’s
Laboratories Ltd.; Zydus Cadila; Lupin Ltd.; PolPharma; Cipla Ltd.; Gedeon Richter
Plc.; Aurobindo Pharma; USV Biologics;
❑ Traditional Brand Companies : Amgen Inc.; Merck & Co., Inc.; Pfizer Inc.; Eli Lilly
and Company; Biogen Inc.; Sanofi; AbbVie Inc.; Boehringer Ingelheim International
GmbH;
types of life-threatening illnesses with unmet needs treated
❑ multiple sclerosis
❑ Anemia
❑ Hemophilia
❑ Cancer
❑ Diabetes
❑ rheumatoid arthritis
HARVONI: Hep C treatment (eg small molecule)
❑ $1000/pill, $84000/treatment
❑ 250000 cases - $21B
In Canada Biologics equal 1.5% of prescriptions, but account for….
1/3 of the total drug costs
true or false: Biosimilars are not the same as generic drugs.
true
Generic drugs are
-small molecules that are chemically synthesized.
-They contain identical medicinal ingredients to their reference products.
A biosimilar and its reference biologic drug can be shown to be….
-highly similar, but not identical.
-biologic drugs are:
* are often large and complex
* are made from living cells, rather than a defined synthetic
chemical process, and are naturally variable
Compared to generics, more studies are needed for the regulatory authorization of a biosimilar in order to
demonstrate that it is highly
similar to its reference biologic drug
Reference Biologic Drug: manifacturers must:
manufacturers must independently demonstrate the quality,
efficacy and safety of the drug.
biosimilar: manifacturers must independently demonstrate what?
the quality of the drug and perform comparative studies to demonstrate highly similar structure, function, efficacy and safety to a previously authorized reference biologic drug.
true or false: there are no clinically meaningful differences in efficacy and safety between the biosimilar and the reference biologic drug
true
Factors that may influence biosimilar uptake
-interchangeability
-payer policies
-switching
-maintaining market shate
Public Drug Programs: Biologics are now not reimbursed if …
biosimilar is available
true or false: biosimilar make you save money
yeah you make so much money
Competition and innovation are inextricably linked – a “virtuous circle”
❑ Originators should realize fair profit and return on investment
❑ Indefinite monopolies lead to
stagnation
❑ Generics/Biosimilars will
increase competition and
encourage “next wave” of drug
innovation
