Glavni bioprodukti v letih od Vir:
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1 Biofarmacevtiki
2 Glavni bioprodukti v letih od Vir:
3 Vir: Ključne prioritete za trajnostno proizvodnjo
4 Deleži biofarmacevtikov na tržišču proteinski terapevtiki leta 2006 Folikle stimulirajoči hormon ali folitropin (FSH) Nadomestni encimi Rastni faktor Cepiva Kolonije spodbujajoči faktorji (CSF) Koagulacijski faktorji Monoklonska protitelesa Interferoni Inzulin Eritropoetin
5 Biološka zdravila Biološka zdravila za zdravljenje revmatoidnega artritisa Mesto delovanja Zaviralci TNF- Zaviralci receptorja IL-1 Zaviralci receptorja IL-6 Delovanje na B-celice Zdravilo etanercept, infliksimab, adalimumab, golimumab anakinra tocilizumab rituksimab Biološka zdravila zavirajo imunske procese in tvorbo določenih posrednikov imunskega vnetja, zato jih imenujemo tudi selektivna imunomodulirajoča zdravila. Imunski sistem, predvsem pri bolnikih z revmatoidnim artritisom, tvori namreč preveč določenih beljakovin, kot so tumorje nekrotizirajoči faktorji αlfa (skrajšano TNF-αlfa) in interlevkina-1 in -6 (skrajšano IL-1, IL-6) ter še nekatere druge, ki so tudi pomembni posredniki sklepnega vnetja. Zdravila anti-tnf-alfa vplivajo na molekule TNF-alfa tako, da se te ne morejo več vključevati v imunska in vnetna dogajanja. Zdravilo rituksimab zmanjšuje število vseh tistih belih krvničk B, ki imajo v celični membrani antigenom CD20. Te celice so sicer neposredno udeležene v vnetju sinovijske ovojnice sklepa. Zdravilo tocilizumab pa je monoklonsko protitelo usmerjeno proti receptorju interlevkina 6 (IL-6), ki je eden izmed ključnih citokinov udeleženih v vnetju pri RA.
6 Uvrstitev Najbolj prodajana biološka zdravila v letu 2012 (vir: Genetic Engineering News ) Biološko zdravilo Ekspresijski sistem Podjetje Svetovna prodaja leta 2012 v milijonih $ Odobrene indikacije za uporabo 1 2 CHO (ovarijske celice kitajskega Humira (adalimumab hrčka =Chinese = zaviralec TNF-alfa) hamster ovary cell) Remicade (infliximab = zaviralec TNF-alfa) Murine Myeloma (mielomske celice glodavcev) AbbVie 9,265 Johnson & Johnson and Merck & Co. 8,215 Moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, moderate to severe Crohn s disease; moderate to severe ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, moderate to severe polyarticular juvenile idiopathic arthritis Moderately to severely active rheumatoid arthritis in adults, in combination with methotrexate; Crohn s Disease in children 6 years and older, and adults who have not responded well to other medicines; rheumatoid arthritis; ankylosing spondylitis; psoriatic arthritis; chronic, severe, extensive, and/or disabling plaque psoriasis in adults; moderately to severely active ulcerative colitis in children 6 years and older and adults that have not responded well to other medicines 3 Enbrel (etanercept = zaviralec TNF-alfa) CHO Amgen and Pfizer 7,963 Moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis
7 Najbolj prodajana biološka zdravila v letu 2012 (vir: Genetic Engineering News ) Uvrstitev Biološko zdravilo Ekspresijski sistem Podjetje Svetovna prodaja leta 2012 v milijonih $ Odobrene indikacije za uporabo 4 Rituxin (rituximab, MabThera = zaviralec CD20) CHO Roche and Biogen Idec 7,285 Non-Hodgkin s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis 5 Lantus (insulin glargine) E.coli Sanofi 6,648 Once daily treatment for diabetes Herceptin (trastuzumab = zaviralec HER-2) Avastin (bevacizumab =zaviralec angiogeneze) Neulasta (pegfilgrastim = granulocitne kolonije stimulirajoči faktor) CHO Roche 6,397 CHO Roche 6,260 HER2-positive breast cancer and HER2-positive metastatic gastric cancer Metastatic colorectal cancer (colon cancer), non small cell lung cancer, glioblastoma & metastatic kidney E.coli Amgen 4,092 Neutropenia caused by cancer chemotherapy
8 Monoklonska protitelesa Monoklonska protitelesa se specifično vežejo na določeno tarčno beljakovino na površini limfomske celice (antigen) in nato sprožijo verižno reakcijo dogodkov, ki vodi v propad limfomskih celic.
9 Pegilacija Izboljšana: - Topnost v vodi - Stabilnost v neugodnih okoljih (ph, topila, T...) - Podaljšana razpolovna doba v telesu
10 Pegilirani produkti na tržišču ZDA
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12 Regulatorne omejitve bioprocesov Glavni cilji bioprocesnih inženirjev: Proizvodnja produkta dovolj visoke kvalitete za zadovoljitev zahtev regulatornih organov (FDA = Food and Drug Administration v ZDA) Znižanje stroškov proizvodnje FDA odobritev za produkt in proces skupaj! Tipični proces pridobivanja odobritve FDA: Odkritje + predklinični testi na živalih: cca 6,5 let Klinični testi 1. faze (20 80 prostovoljcev): cca1 leto Klinični testi 2. faze ( pacientov): cca 2 leti Klinični testi 3. faze ( pacientov): cca 3 leta Pregled rezultatov pred odobritvijo: cca 1,5 let Skupaj povprečno15 let, cena: 400 milijonov $ (1996) 10 % zdravil pridobi odobritev
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14 Regulatorne omejitve bioprocesov FDA odobritev za produkt in proces skupaj! Majhne spremembe v procesu lahko privedejo do tragičnih posledic. Sprememba procesa zahteva ponovne klinične teste. Zdravila na tržišču in uporabljena v kliničnih testih morajo biti proizvedena v skladu z dobro proizvodno prakso (GMP = good manufacturing practice)
15 GMP in GLP Dobra proizvodna praksa (GMP) se nanaša na: uporabljeno proizvodno opremo in postopke (ne sme priti do kontaminacij produkta, določen tok snovi, osebja in zraka) usposobljenost osebja v proizvodnji nadzor vstopnih snovi (surovine, kulture) ravnanje s produktom vsi računalniški programi morajo biti validirani Off- line analize morajo biti narejene v skladu z dobro laboratorijsko prakso (GLP = good laboratory practice) Postopki so dokumentirani z SOP (standard operating procedures).
16 Validacija procesa Običajno zelo dolgotrajni in kompleksni postopki. Validacija procesa je uveljavljanje dokumentiranega dokaza, ki daje visoko stopnjo zagotovitve, da bo specifični proces konsistentno proizvajal produkt, ki bo v skladu z njegovimi predhodno določenimi specifikacijami in karakteristikami kvalitete.
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Regulatory Status FDA- approved indication: Simponi and Simponi ARIA are tumor necrosis factor (TNF) blockers indicated for the treatment of:
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.51 Subject: Simponi / Simponi ARIA Page: 1 of 8 Last Review Date: March 17, 2017 Simponi / Simponi
Regional vs. Systemic Therapy. Corticosteroids. Regional vs. Systemic Therapy for Uveitis. Considerations
Regional vs. Systemic Therapy for Uveitis Nisha Acharya,, M.D., M.S. Director, Uveitis Service F.I. Proctor Foundation University of California, San Francisco December 4, 2010 No financial disclosures
Remicade (infliximab), Inflectra (infliximab-dyyb), Renflexis (infliximababda)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.02 Subject: Infliximab Page: 1 of 13 Last Review Date: December 8, 2017 Infliximab Description Remicade
Corporate Medical Policy
Corporate Medical Policy Rituximab for the Treatment of Rheumatoid Arthritis File Name: Origination: Last CAP Review: Next CAP Review: Last Review: rituximab_for_the_treatment_of_rheumatoid_arthritis 4/2008
Otezla. Otezla (apremilast) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Otezla Page: 1 of 5 Last Review Date: March 16, 2018 Otezla Description Otezla (apremilast) Background
10 Musculoskeletal and Joint Diseases
Recommendations from the Lothian Formulary Committee (FC) following Scottish Medicines Consortium (SMC) advice, NICE MTA advice, (FAF3) unlicensed and off-label medicines and (FAF2) medicines not considered
Corporate Medical Policy
Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: golimumab_simponi 8/2013 2/2018 2/2019 3/2018 Description of Procedure or Service Golimumab (Simponi and
Amjevita (adalimumab-atto) CG-DRUG-64, CG-DRUG-65
Market DC Amjevita (adalimumab-atto) CG-DRUG-64, CG-DRUG-65 Override(s) Prior Authorization Quantity Limit Medications Amjevita 20 mg/0.4 ml prefilled syringe Amjevita (adalimumab-atto) 40 mg/0.8 ml 2
Regulatory Status FDA-approved indication: Orencia is a selective T cell co-stimulation modulator indicated for: (1)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Orencia Page: 1 of 9 Last Review Date: September 20, 2018 Orencia Description Orencia (abatacept)
Pharmacy Management Drug Policy
SUBJECT: Inflammatory Conditions Clinical Review Prior Authorization (CRPA) Rx and Medical Drugs POLICY NUMBER: PHARMACY-73 EFFECTIVE DATE: 01/01/2018 LAST REVIEW DATE: 06/11/2018 If the member s subscriber
Orencia (abatacept) DRUG.00040
Market DC Orencia (abatacept) DRUG.00040 Override(s) Prior Authorization Quantity Limit Approval Duration 1 year Medications Comments Quantity Limit Orencia (abatacept) - AGP, VA MCD only 4 vials per 28
Regulatory Status FDA-approved indication: Enbrel and Erelzi are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.27 Subject: Enbrel Page: 1 of 8 Last Review Date: March 16, 2018 Enbrel Description Enbrel (etanercept),
Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC
Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC Update on the Treatment of Rheumatoid Arthritis Sabrina Fallavollita MDCM McGill University Canadian Society of Internal Medicine
UnitedHealthcare Pharmacy Clinical Pharmacy Programs
Program Number 2017 P 3041-8 Program Step Therapy Medications UnitedHealthcare Pharmacy Clinical Pharmacy Programs *Orencia (abatacept) *This step criteria refers to the subcutaneous formulation of abatacept
Step Therapy Approval Criteria
Effective Date: 10/01/2016 This document contains Step Therapy Approval Criteria for the following medications: 1. Colcrys (colchicine) 2. Cymbalta (duloxetine) 3. Dovonex (calcipotriene) 4. Enbrel (etanercept)
(tofacitinib) are met.
Xeljanz (tofacitinib) Policy Number: 5.01. 560 Origination: 3/2014 Last Review: 3/2014 Next Review: 3/2015 Policy BCBSKC will provide coverage for Xeljanz (tofacitinib) when it is determined to be medically
Carelirst.+.V Family of health care plans
Carelirst.+.V Family of health care plans CVS Caremark POLICY Document for ACTEMRA The overall objective of this policy is to support the appropriate and cost effective use of the medication, specific
Targeted Immune Modulators
Oregon Health Resources Commission Targeted Immune Modulators Subcommittee Report Update #1, April 2007 TIMs Subcommittee Report of March 2006. All revisions are highlighted. Produced by: Health Resources
TNF Inhibitors: Lessons From Immunogenicity
TNF Inhibitors: Lessons From Immunogenicity Edward Keystone, MD, FRCP(C) Professor of Medicine University of Toronto Toronto, Canada Edward Keystone, MD FRCP(C) Disclosures Sources of Funding for Research:
Remicade and Friends What You Need to Know Treating the Patient on TNF-alpha Inhibitors and Related Meds
Remicade and Friends What You Need to Know Treating the Patient on TNF-alpha Inhibitors and Related Meds Scott Stienecker MD FACP FSHEA Medical Director for Epidemiology and Infection Prevention Parkview
ACTEMRA (tocilizumab)
Pre - PA Allowance None Prior-Approval Requirements Diagnoses Patient must have ONE of the following: 1. Active Polyarticular Juvenile Idiopathic Arthritis (PJIA) b. Patient has an intolerance or has experienced
1.0 Abstract. Title P13-562
1.0 Abstract Title P13-562 Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn s Disease and Ulcerative Colitis patients`adherence attitudes to maintenance
Xeljanz (tofacitinib), Xeljanz XR (tofacitinib extended-release)
Market DC Xeljanz (tofacitinib), Xeljanz XR (tofacitinib extended-release) Override(s) Prior Authorization Quantity Limit Medications Xeljanz (tofacitinib) Approval Duration 1 year Quantity Limit May be
1. Does the patient have a diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis (PJIA)?
Humira (adalimumab) Medication Request Form (MRF) for Healthy Indiana Plan (HIP) and Hoosier Healthwise (HHW) FAX TO: (858) 790-7100 c/o MedImpact Healthcare Systems, Inc. Attn: Prior Authorization Department
2019 COLLECTION TYPE: MIPS CLINICAL QUALITY MEASURES (CQMS) MEASURE TYPE: Process
Quality ID #337: Psoriasis: Tuberculosis (TB) Prevention for Patients with Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis on a Biological Immune Response Modifier National Quality Strategy Domain: