BIOTECH SOLUTIONS TO HEALTHCARE CHALLENGES

BIOTECH MEDICINAL PRODUCTS

Medicines with a Community marketing authorisation
It is all about the quality, safety and efficacy of your medicines Before a new medicine can be made available to patients, pharmaceutical companies must prove that a product is safe, that it is efficacious (i.e., that it works) and that it is of high quality. Only when this is proven can a new medicine be made available to patients. To demonstrate this, pharmaceutical companies conduct a complex and lengthy series of tests. These are aimed at identifying the product s particular properties and cover toxicity, pharmacology and clinical tests. The results are evaluated by public health authorities to verify the quality, safety and efficacy of the medicine. Only when they have evaluated the results of these tests will the authorities authorise a medicine to be sold, by granting a marketing authorisation (MA). In order to harmonise this approval process throughout Europe, the European Agency for Evaluation of Medicinal Products (EMEA) was established. It started its work in 1995. This means that there are now two systems for authorising medicines in the EU the Centralised Procedure and the Mutual Recognition Procedure (or national procedure). What is the Centralised Procedure leading to an EU-wide community marketing authorisation? In many cases, companies many choose if they use the Mutual Recognition Procedure or the Centralised Procedure. However, in the case of biopharmaceuticals, it is compulsory to use the Centralised Procedure. Applications for a marketing authorisation are made directly to the EMEA and are evaluated by one of the scientific committees. There is a set timeframe in which the evaluation must be completed, but this period may be interrupted where the committee requires further information from an applicant. On the basis of the EMEA opinion, the European s Commission is responsible for granting a marketing authorisation. A Community marketing authorisation is valid in all 15 European Union Member States. The EMEA, together with network of national authorities, carefully monitors all centrally authorised products once they are in use. This in-use monitoring is called pharmacovigilance and is aimed at ensuring , patient safety on a continuous basis. How many biotech products have been authorised by the EMEA? Total = 95 (as at October 2003 not entire 2003)
16 13 11 9 6 3 4 16 17

1995

1996

1997

1998

1999

2000

2001

2002

2003

The complete list of all centrally approved products is available on the EMEA website at: http://www.emea.eu.int/pdfs/general/direct/listprod/3 032703en.pdf
EBE (Emerging Biopharmaceutical Enterprises) aims to promote a positive scientific, economic and regulatory environment for healthcare companies involved in life science technologies within Europe. The EBE group currently comprises 37 members engaged in research in Europe involving the application of emerging bioscience technologies with the aim of launching new healthcare products. For more information, please visit:

www.ebe-efpia.org

Leopold Plaza Building Rue du Trne 108, Bote 1 B-1050 Bruxelles Belgique Tel: + 32 (0)2 626 25 55 Fax: + 32 (0)2 626 25 66 E-mail: ebe@efpia.org Website: www.ebe-efpia.org

A specialised group within EFPIA

CENTRALLY APPROVED BIOTECHNOLOGY MEDICINAL PRODUCTS

Brand Name Gonal-F Betaferon NovoSeven Humalog Puregon CEA Scan Tecnemab K 1 Ecokinase Tritanrix-HepB International Name follitropin alfa Interferon beta 1b eptacog alfa (activated) insulin lispro follitropin beta arcitumomab Anti-melanoma antibody Reteplase Comb vaccine DTPwHepB Indication Treatment of infertility Treatment of Multiple sclerosis Coagulation factor Diabetes Mellitus Treatment of infertility Diagnosis of colonic and rectal carcinoma Diagnosis of cutaneous melanoma lesions Treatment of acute myocardial infarction Active immunisation against Diphteria, tetanus, pertussis, and Hepatitis B in infants Thrombolytic therapy of acute myocardial infarction Vaccine for immunisation against Hepatitis A and B Diagnosis of Ovarian Adeno-carcinoma Immunisation against hepatitis A and B in non immune infants, children and adolescents Diagnostic agent Diabetes Mellitus Bacterial and viral combined vaccines Treatment of ambulatory patients with relapsing multiple sclerosis Anticoagulation therapy for heparin-associated thrombocystopenia Prevention of venous thrombosis Treatment of anaemia Active immunisation against diphteria, tetanus and hepatitis Haemophilia B, factor IX deficiency Company Ares Serono (Europe)Ltd Schering AG Novo Nordisk Eli Lilly N.V. Organon Immunomedics B.V. Sorin Galenus Mannheim Glaxo SmithKline Biologicals Date of MA 1995 1995 1995 1996 1996 1996 1996 1996 1996

Rapilysin

reteplase

Hoffmann-La Roche Ltd. Glaxo SmithKline Biologicals CIS Bio International Glaxo SmithKline Biologicals

1996

Twinrix adult Indimacis 125 Twinrix paediatric

Comb HepA and B vaccine Igovomab Comb Hep A and B vaccine

1996 1996 1997

Leukosan Insuman Primavax Avonex

sulesomab Human insulin Combined vaccines Interferon beta-1a

Immunomedics B.V. Aventis Pasteur Merieux MSD Biogen France S.A.

1997 1997 1997 1997

Refludan

Lepirudin

Schering AG

1997

Revasc Neorecormon Infanrix

desirudin Epoetin beta DTPa-HepB vaccine

Aventis Hoffmann-La Roche Ltd. GlaxoSmithKline Biologicals S.A. Genetic Institute of Europe B.V

1997 1997 1997

Benefix

Nonacog alfa

1997

Cerezyme

imiglucerase

Rebif Mabthera Humaspect Simulect

Interferon beta 1a rituximab votumumab basiliximab

Triacellucax

Bacterial vaccine

Forcaltonin

Recomb salmon calcitonin saruplase

Rescupase

Infergen Zenapax Thyrogen Alfatronol

Interferon alfacon-1 daclizumab Thyrotrophin alfa Interferon alpha-2b

Virtron Regranex

Interferon alpha-2b becaplermin

Beromun

tasonermin

Refacto Procomvax

Moroctocog alfa Haemophilus b conjugated and hepatitis B vaccine infliximab palivizumab

Remicade Synagis

Novorapid Enbrel

Insulin aspart etanercept

Replacement therapy in patients with a type I Gaucher diseases Treatment of multiple sclerosis Treatment of stage III-IV follicular lymphoma Imaging of carninoma of colon or rectum Prophylaxis of acute organ rejection in the novo renal transplantation Pediatric vaccine for diphteria, tetanus and pertussi Paget diseases and s hyprercalcaemia of malignacy Thrombolytic Therapy for acute myocardial infarction Treatment of chronic hepatitis C Prophylaxis of acute renal transplant rejection Detection of thyroid cancer Treatment of Chronic hepatitis B and C, Hairy Cell Leukaemia, chronic Myelogenous, Leukaemia, Multiple Myeloma, Follicular Lymphoma, Carcinoid Tumors and Malignant Melanoma Treatment of Chronic hepatitis B and C To promote healing for full-thickness diabetic ulcers Adjunct therapy to surgery for irrescectable soft tissue sarcoma of the limbs to prevent or delay amputation. Control and prevention of haemorrhagic episodes Immunication against Haemophilus influenza type B and infection by hepatitis B virus in infants Treatment of Crohn s Diseases Prevention of serious lower respiratory tract diseases Treatment of diabetes mellitus Treatment of active rheumatoid arthritis

Genzyme B.V.

1997

Ares Serono Europe Hoffmann-La Roche Ltd. Organon Teknica B.V. Novartis Europharm Ltd Chiron S.p.a.

1998 1998 1998 1998

1998

Unigene UK Limited

1999

Gruenenthal GmbH

1998

Yamanouchi Europe B.V Hoffmann-La Roche Ltd. Genzyme B.V SP Europe USA

1999 1999 1999 1999

SP Europe USA Janssen-Cilag International B.V. Boehringer Ingelheim International

1999 1999

1999

Genetic Institute of Europe B.V. Pasteur Mrieux MSD

1999 1999

Centocor B.V. Abbott Laboratories

1999 1999

Novo Nordisk Wyeth Europe Ltd.

1999 2000

Intron A

Interferon alfa-2b

Viraferon Pegintron Viraferon PEG Lantus Optisulin NovoMix 30 KOGENATE

Interferon alfa-2b Peginterferon alfa-2b Peginterferon alfa-2b Insulin glargine Insulin glargine Insulin aspart Octocog alfa

Treatment of chronic hepatitis B and C, Hairy Cell Leukemia, Multiple Myeloma, Follicular Lyphoma, Carcinoid Tumours and Malignant Melanoma Treatment of chronic hepatitis B and C Treatment of chronic hepatitis C Treatment of chronic hepatitis C Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus Treatment and prophylaxis of bleeding in haemophilia A Treatment and prophylaxis of bleeding in haemophilia A Immunisation against hepatitis B virus in adults Treatement of patients with metastatic breast cancer whose tumour overexpress HER2 Immunisation against Haemophilus influenza, Diphteria, Pertussis, Tetanus, HepB and Poliomyelitis Primary and booster immunisation of infants against Diphteria, Tetaunus Pertussis, Hep B and Poliomyelitis Immunisation Diphteria, Pertussis, Tetanus, Hep B, Poliomyelitis, Haemophilus Influenza Stimulation of follicular development in women with sere Lend Heng and FHS deficiency Treatment of women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation Active immunisation of infants and children against invasive diseases, pneumonia and otitis media caused by streptococcus pneumoniae

SP Europe

2000

SP Europe SP Europe SP Europe Aventis Pharma Deutschland GmbH Aventis Pharma Deutschland GmbH Novo Nordisk Bayer AG

2000 2000 2000 2000 2000 2000 2000

Helixate NexGen Hepacare Herceptin

Octocog alfa

Bayer AG

2000

Triple antigen hepatitis B vaccine trastuzumab

Medeva Pharma Ltd Hoffmann-La Roche Ltd.

2000 2000

Infanrix hexa

Hep B-IPV HIB vaccine

GlaxoSmithKline Biologicals SA

2000

Infanrix penta

HepB-IPV vaccine

GlaxoSmithKline Biologicals SA

2000

Hexavac

Comb vaccine

Pasteur Mrieux MSD

2000

Luveris

Lutropin alfa

Ares Serono Europe

2000

Ovitrelle

Choriogonadotropin alfa

Ares Serono

2001

Prevenar

Peumococcal conjugate vaccine

Wyeth-Lederle Vaccines SA

2001

Nutropin Aq

Metalyse Fasturtec Tenecteplase HBVAXPRO

Somatropin Recombinant DNA origin Tenecteplase rasburicase tenecteplase Recombinant Hepatitis B virus small surface antigen (HbsAg) Eptotermin alfa

Treatment of growth failure Treatment of suspected myocardial infarction Treatment of tumor induced phreuricemia Treatment of suspected myocardial infarction Active immunisation against hepatitis B virus infection caused by all know subtypes in children and adolescents Treatment of non-union tibia of at least 9 month duration Treatment of anaemia associated with chronic renal failure Treatment of anaemia associated with chronic renal failure Treatment and prophylaxis of bleeding in patients with haemophilia B Second-line treatment of chronic lymphocytic leukemia Indicated in purpura fulminans and coumarin induced skin necrosis in patiens with severe congenital protein C deficiency Diabetes Mellitus Long-term replacement therapy in patients with a confirmed diagnosis of Fabry Diseases Long-term replacement therapy in patients with a confirmed diagnosis of Fabry Diseases Treatment of the signs and symptoms of rheumatoid arthritis Treatment of anaemia in patients with chronic renal failure Treatment of chronic hepatitis in adults Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy

Ipsen

2001

Boehringer Ingelheim International Sanofi Boehringer Ingelheim International Aventis Pharma SA

2001 2001 2001 2001

Osigraft

Nespo

darbepoetin

Howmedica International S. de R.L. Domp Biotech

2001

2001

Aranesp

Darbepoetin alfa

Amgen Europe

2001

Nonafact

Human coagulation factor IX

Sanquin

2001

MabCampath

alemtuzumab

Millenium & Ilex UK Ltd Baxter AG

2001

Ceprotin

Protein C

2001

Liprolog Fabrazyme

Insulin lispro Agalsidase beta

Eli Lilly Genzyme BV

2001 2001

Replagal

Agalsidase alfa

TKT Europe-5S AB

2001

Kineret

anakinra

Amgen Europe

2002

Dynepo

Epoetin delta

Aventis

2002

Pegasys Neupopeg

Peginterferon alfa-2a Pegfilgrastim

Hoffmann-La Roche Ltd. Amgen Europe

2002 2002

Neulasta

Pegfilgrastim

Xigris

Drotrecogin alfa (activated)

Ambirix

Inactivated hepatitis A virus, Hepatitis B surface antigen (rDNA)

Mixtard Actaphrane Velosulin Actrapid Protaphane Ultratard Monotard Insulatard InductOs

Human insulin, rDNA Human insulin, rDNA Human insulin, rDNA Human insulin, rDNA Human insulin, rDNA Human insulin, rDNA Human insulin, rDNA Human insulin, rDNA Dibotermin alfa

Somavert

Pegvisomant

Aldurazyme

Laronidase

Forsteo

Teriparatide

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy Treatment of adult patients with severe sepsis with multiple organ failure Protection against hepatitis A and hepatitis B infection in nonimmune children and adolescents from 6 years up to and including 15 years Treatment of diabetes mellitus Treatment of diabetes mellitus Treatment of diabetes mellitus Treatment of diabetes mellitus Treatment of diabetes mellitus Treatment of diabetes mellitus Treatment of diabetes mellitus Treatment of diabetes mellitus Treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary nail fixation. Treatment of patients with acromegaly who had an inadequate response to surgery and/or to radiation therapy Long term replacement therapy in patients with confirmed diagnosis of mucopolysaccharidosis Treatment of established osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated

Amgen Europe

2002

Eli Lilly Nederland

2002

GlaxoSmithKline Biologicals

2002

Novo Nordisk Novo Nordisk Novo Nordisk Novo Nordisk Novo Nordisk Novo Nordisk Novo Nordisk Novo Nordisk Genetic Institute of Europe

2002 2002 2002 2002 2002 2002 2002 2002 2002

Pharmacia Enterprise S.A.

2002

Genzyme B.V.

2003

Eli Lilly and Company

2003

Trudexa

Adalimumab

Humira

Adalimumab

Reducing signs and symptoms and inhibiting progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis Reducing signs and symptoms and inhibiting progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis

Abbott Laboratories

2003

Abbott Laboratories

2003

Information based on EMEA website. For more information please visit: http://www.emea.eu.int/index/indexh1.htm#