Friday, September 28, 2018
Generics and Biosimilars
Patents and Exclusivity of Generics
- Patents- properly right issued by the United States Patent and Trademark Office (USPTO) to the inventor to "exclude others from making, using, offering for sale, or selling the invention" for limited time, in exchange for public disclosure
- Exclusivity- grants exclusive marketing rights by FDA, can run concurrently with or without patent, varies on classification of drug, begins upon approval for 5 years - Brand-name drug- a drug marketed under a proprietary, trademarked name - Generic drug- a drug that is equal to the the brand-name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use - FDA approval of generics requirements: - Pharmaceutically equivalent- same active ingredients, dosage, form, strength, and how it is taken Bioequivalent- must act on body in the same manner and to the same degree as brand-name drug (+/- 10% concentration in the blood)
Safe and effective- show Abbreviated New Drug Application
Manufactured in compliance with Current Good Manufacturing Practice
: Adequately labeled
- Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)
Encourages competition to keep market prices fair and rewards technological innovation Established streamlined approval for generic drugs - Bioequvalence
- No duplicate clinical trials
- Granted 180 day exclusivity (unusual for generics) Increased number of generic drugs dramatically (~88% of all prescriptions)
Extended patent rights to new drugs of innovator companies
- Abbreviated New Drug Application (aNDA) : Costs significantly less
- First 12-18 months are dedicated to investigating chemistry, manufacturing, and controls (CMC) of drug
1
Friday, September 28, 2018
: Following 3-6 months are dedicated to investigating bioavailability and bioequvalency - Cost of generic drugs: - Price is much cheaper than brand-name drug - Initial research/development is costly for brand-name drugs - NDA vs aNDA cost
- Generic drugs are perceived to be "less safe" than brand-name drugs
- No regulation for generics to have the same inactive ingredients
- Allergic reactions are a potential reason for this belief
Illusion of bargain- health care covers the cost of brand-name so it's the same for the patient
Treatment of GERD (acid reflux)- when acid from there stomach comes up into the esophagus
Treated with proton pump inhibitors: Nexium and Prilosec
- Both come from the same company, same compound but just mirror images of each other
Enatiomers- optical isomers, two stereoisomers that are related to each other by reflection
- Nexium requires perscription, Prilosec is over the counter (cheaper)
- Nexium's generic is much cheaper and is proven to have the same efficacy, yet Nexium is much more popular
- General marketing promotions - ex. Give away free nexium to hospitals --> hospitals prescribe nexium -- residents learn from attendings to prescribe nexium
- Health care and insurance companies are starting to tier their drugs to force patients to obtain generic drugs more often due to cost (insurance companies are now discouraging this)
Biopharmaceuticals
- Much more complex than drugs Drugs