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1

What type of Phamaceutical Industry?

•more DIVERSE medications, chemical drug products ”blockbusters”

•Blockbuster = >1BILLION IN SALES

"Discovery of important new medicines for patients by pharmaceutical and biotechnology research companies​"

Research Intensive

TRADITIONAL

2

What type of Pharm Industry?

• ~50% from biotech

•Many TRADITIONAL Big Pharma Companies are SHIFTING TO BIOTECH

Research-Intensive

BIOTECH

3

Global Pharm Market

•Global spending on medicines ~ $1.1 trillion

Forecast to reach nearly $1.5 trillion by 2021

 

•US spending represents
over a third of global pharma sales

>1/3

4

Major Trade Association

for

BIG PHARMA

PhRMA

Pharmaceutical Research and Manufacturers of America

Research intensive
discovery or development of
 Brand-Name / Innovator Drugs

5

Research-intensive pharmaceutical industry:
positions of support

THEY LOBBY FOR THESE THINGS

  • Modernizing drug discovery, development and approval:
    •     - Innovative drug research
    •     - Swift development and approval of safe and effective drugs
    • Scientifically sound, efficient FDA approval
  • Broad patient access to medicines through a free market
  • •Securing the pharmaceutical supply chain
  • Promoting the value of pharmaceuticals in “value-driven health care
  • •Health care liability reform
    • –FDA defense to punitive damages
      • Should NOT be SUED for whats in the drug. In the hands of Doctors/Pharmacist to know whats in the drug
  • •Strong intellectual property incentives

6

Brand-name pharmaceutical industry
 oppositions:

what they OPPOSE / lobby AGAINST

Restrictive formularies (Medicaid, hospital, managed care, etc.)

•Preferred drug lists

–But they DO LIKE DUR’s and things that protect the patient

•Prior authorization

Limits on prescription reimbursement

•Price controls

7

Investigational New Drug Application (IND)

•What is this used for?

 means by which a pharmaceutical company obtains permission
to ship an experimental drug across state lines 
(usually to clinical investigators)
before a marketing application for the drug has been approved.

8

Drug Development TIME & COST

>10 YEARS

2.6 BILLION
for a NEW DRUG
includes FAILURES + CAPITAL expenses

9

PATENTS

Issued by the

US Patent Trademark Office = PTO

Patents expire 20 years from the date of filing​
but other factors AFFECT IT
Exclusivity / Patent Term Restoration Activites / Court Challengs

10

1984 Drug Price Competition and Patent Term Restoration Act
(Hatch-Waxman Act)

allowed patent holders to recoup some lost patent time
i.e., extended effective patent life)
 

•Patent extension application
must be filed with the PTO
within 60 days of FDA approval of the drug product

11

How long can effective patent term  be extended?

ONE HALF of the period in clinical Trails
+
ENTIRE PERIOD of FDA REVIEW

MAX OF 5 YEARS can be restored to patent
///
TOTAL patent live WITH the PATENT EXTENSION
MAX OF 14 YEARS from the product's approval date

12

Exclusivity

SEPERATE 
it is NOT ADDED
it is GIVEN UPON THE APPROVAL

 exclusive marketing rights
granted by the FDA

upon drug approval (granted to NDA holder) and
can run concurrently with a patent or not.

During exclusivity period, no company can submit generic drug application
(abbreviated new drug application, ANDA
) to FDA seeking approval of a drug product containing the new chemical entity

–No other company can submit a “generic” when it is under approval.

13

ANDA

Abbreviated New Drug Application

a
GENERIC DRUG Application given to the FDA
seeking approval of a drug product contianing 
"new chemical entity"

14

Length of Market Exclusivity

New Chemical Entity = 5 YEARS

Novel Biologic = 12 YEARS

&

the FIRST SUCCESSFUL PATENT CHALLENGE
180 DAY EXCLUSIVITY

worth A lot --> first generic drug approved gets this

15

Define:
•(i.e., cellular and biomolecular processes), usually involving living cells and proteins

contain large, complex or long-chained proteins − unlike conventional drugs (which are small-molecule chemicals)

Many “specialty drug products”

Biopharmaceuticals

  • •Granulocyte-colony stimulating factors
  • •Recombinant growth factors
  • •Interferons
  • •Interleukins
  • •Monoclonal antibodies
  • •Recombinant hormones
  • •Certain vaccines (e.g., Hepatitis B surface antigen)
  • •Recombinant thrombolytics, anticoagulants
  • •Blood factors (Factor VIII, Factor IX)
  • •Others

16

BLA

BIOLOGICS License Application
similar to NDA

only need 1 CLINICAL TRIAL vs NDA

 

Similar position statements of other research-intensive pharmaceutical companies, except desire separate  reimbursement methods for drugs and biologics

•Spends higher percentage on R&D

 

17

Biotechnology Industry Organization (BIO)

Major BP Trade Association
in comparison to PhRMA

Represents biotech companies, universities, research institutions, state biotechnology associations and affiliates ​

Many Pharm Companies belong to
BOTH PhRMA & BIO

18

BIOSIMILAR

AKA = Follow-On Biologics /// Follow-On Proteins

•Biosimilar is a biological product demonstrated to be “highly similar’ to an FDA-licensed reference product

•Large molecules for follow-on biologics are difficult to characterize fully

•Proteins produced through complex manufacturing processes;
may be differences in safety/efficacy profiles

19

Purple Book

NEW BIOLOGICS & BIOSIMILARS

similar to the

Orange Book for Generics

20

The Generic Pharmaceutical Industry

Providing consumers with safe and effective, quality drug products
at low costs

Trade Association = GPhA
Generic Pharm Association

21

Generic Drug Review and
Approval Process

average of 41 MONTHS to approve a generic

•Applicant (pharmaceutical firm) submits an
abbreviated new drug application (ANDA)
or an abbreviated antibiotic drug application (AADA)
to obtain FDA approval

22

TREND of
US RX Market Share

By dollars =
brand name > unbranded > branded
brand name makes the MOST money

  By volume
unbranded generics are MORE OFTEN DISPENSED
> brand name drugs > branded generics

 

23

Branded Generic

aka AUTHORIZED GENERIC

Made by the SAME COMPANY
as the INNOVATOR
or one of its sister companies

24

Generic Pharmaceutical Industry
positions of support:

Promoting and expanding the free market forces in the pharmaceutical industry

•Reducing generic approval backlog

•Supply chain security

•Abbreviated FDA approval process for biosimilars

25

Generic Pharmaceutical Industry
 Oppositions

Slow FDA review times for ANDAs

Brand name (research-intensive) drug industry efforts to extend patents, e.g., court challenge

•Other “evergreening” strategies by Big Pharma industry to delay market introduction of generics

•Requirement of ‘authorized generics’ = branded generic name
CAN BE MADE even in the period of exclusivity

•Restrictions on rights to settle drug patent disputes out of court

26

•Planning (macro) level 

•Macro-level core functions: 
 assessment, policy development, and assurance

Micro = IMPLEMENTATIOn

27