The Biotech Industrys Views on the Pharma Review Package

1
The Biotech Industrys Views on the Pharma Review
Package

• Hugo Schepens, EuropaBio
• Erik Tambuyzer, Chair, EuropaBio Healthcare Board
• Thomas Bols, Chair, Pharma review Working Group
• 4 November 2003

2
Objective of the Briefing

• Healthcare biotech in Europe brief introduction
• What is the pharma review and where are we now?
• What is the impact on healthcare biotech?
• Next steps
• Questions and answers

3
How biotech is meeting unmet medical needs

• Today there are many more diseases than
  treatments. Just 10,000 of the 30,000 known
  diseases have treatments available
• Cancer, infectious diseases like AIDS and
  autoimmune disorders (motor neuron disease, etc)
  and neurodegenerative diseases like Parkinsons
  and Alzheimers, as well as rare genetic
  diseases.

4
The healthcare biotech industry

• Some statistics!

5
The healthcare biotech industry
New medicines in development
Medicines currently on the market
Source European Commission
6
The healthcare biotech industry people
companies EU vs. US
Source Ernst Young
7
The healthcare biotech industry Revenues RD
EU vs. US
Source Ernst Young
8
Biotech medicines

• Biotechnology is based on a knowledge of living
  systems
• Biotech medicines are usually identical or
  similar to molecules found naturally in the body
• They treat conditions such as anemia, cystic
  fibrosis, cancers, haemophiliae and multiple
  sclerosis
• The body assimilates biotech medicines as if it
  is one of the bodys own natural substances

9
Differences in Complexity
Interferon
Aspirin
10
Complexity Difference in Weight
The molecular weights (in daltons, the standard
unit of molecular mass) of some popular
drugsSource Lisa Raines, Genzyme 2001
  Chemical Glucophage 166 Vioxx 314 Prozac 34
6 Zantac 351 Paxil 375 Claritin 383 Zocor
419 Augmentin 420 Crixivan 712 Taxol 854  
     
Biotechnology products Neupogen
18,800 Intron-A 19,625 Humatrope
22,125 Avonex 22,500 Epogen
30,400 Pulmozyme 37,000 ReoPro
47,615 Enbrel 75,000 Zenapax
144,000 Rituxan 145,000
11
What is the Pharma Review?

• What?
• July 2001 Revision EU pharmaceuticals
  legislation
• EMEA operations (Regulation 2309/93)
• Code for human medicines (Directive 2001/83)
• Code for veterinary medicines (Directive 2001/82)
• Why?
• Commitment to review working of EMEA
• Promote public health
• Simplify medicine authorisation procedures
• Improve operations for pharma industry
• Prepare for enlargement
• Topics covered?
• Functioning EMEA
• Harmonisation of Regulatory Data protection
• Centralised and decentralised marketing
  authorisation procedure
• Regulation of Biosimilar products
• Opening up Direct-to-consumer Advertising/Informat
  ion debate

12
What is the Status of the Review?

• June 2003 political agreement by Council of
  Ministers
• 29 September 2003 Common Position by Council of
  Ministers
• 10 October 2003 - January 2004 Second Reading
  Opinion European Parliament
• lt February 2004 Final adoption?
• lt 2006 Transposition into national law?

13
Three key elements of the pharma review

• Harmonization of the Regulatory Data protection
• Updating the centralized and decentralized
  Marketing authorization
• Approval system for biosimilar medicinal products

14
Harmonization of the Regulatory Data protection

• What is data protection versus a patent?
• What is the proposal?
• What is the biotech industrys view?

15
Regulatory Data Protection versus Patent
ProtectionWhat Does It Protect?
Data is protected for 10 years no
competitor can refer to data for approval of
their medicines
Regulatory Data Protection
Room full of files to demonstrate that Medicine
is safe, efficacious and of good quality
Scientists Patients Doctors involved in testing
of substance
Potential Medicine
Medicine is approved
Marketing authorisation/Start data protection
Patent expiration
Discovery molecule
8-10 years
20 years
Patent Protection
Scientist invents substance
Patent application for substance is filed
Patent is granted
No competitor can use substance during 20 years -
starts from filing date
Thanks to BMS
16
 
Status of the Proposal Regulatory Data
Protection (RDP)
generics can submit the application after 8
years but marketing authorisation can only be
granted after 10 years generics can submit the
application after 8 years but the generic cannot
be commercialised until the 10 years have
elapsed  
17
What Is the Biotech Industrys View?

• 10 years RDP situation since 1995 for biotech
  medicinal products (mandatory centralised
  procedure)
• Any step back would be unacceptable
• 10 years RDP necessary to recoup investments

18
Centralised Procedure

• Continuation of centralised procedure for Biotech
  medicinal products
• New products quicker to patients
• Uniform treatment of biotech products
• Build up of expertise in one place

19
Approval system for biosimilar medicinal products

• What is the difference between a generic and a
  biosimiliar product?
• What is in the proposal?
• What are the biotech industrys views?

20
What Is the Difference Between a Chemical and a
Biologic?

• Chemical medicine and generic copies
• Original biologic and biosimilar Not copies
• Biosimilar products are not generic products
•  
• A generic drug is approved by reference to a
  strict definition of sameness to an innovators
  product i.e. it is a copy
•  
• Sameness, however, cannot be determined for
  biologics because of the complex nature of the
  products and their manufacturing processes
• Therefore, generic biologics, produced by
  different manufacturers, do not exist but similar
  ones do!

21
What Is the Proposal?

• Article 10 legal basis
• Requirements for the approval of a biosimilar
  products
• Makes a reference to Annex 1 (Directive 2003/63)
  re what are biosimilars and conditions for
  approval. Directive entered into force in
  October 2003

22
What Is the Biotech Industrys View?

• Clear recognition that biosimilars are special
  medicines
• Appropriate tests on animals and humans to
  guarantee patient safety
• Need not be full repetition of tests and trials

23
Next steps

• Second Reading
• Council review of Second Reading 23 December
• To go to conciliation or not, that is the
  question!
• Industry supports agreement by the end of year
  and avoid a lengthy conciliation procedure

24
THANK YOU ! EuropaBio's address is Avenue de
l'Armée 6 1040 Brussels Belgium Tel (32.2)
735.03.13 Fax [phone] E-mail
mail_at_europabio.org