식약처에서는 4차 산업혁명산업혁명시대의 신기술 출현에 따른 의약품 개발 환경의 변화와 실제 업계 사용자들의 의견을 적극적으로 반영하여 '18년도 의약품 허가·심사 가이드라인 개발 및 운영 계획을 수립하고자 함

• 의견제출양식: 발간제안서(붙임1)
• 의견조회기한: ~'17.12.21(목)까지
• 제출처: 검토의견서 johs8739@kobia.kr 송부

의약품 허가특허연계제도 질의응답집 (2017-12-12) 발간

신청자

승인일

시험제목

제품명

p

한국 아스트라
제네카

20171211

항-PD-1/PD-L1 제제 포함 치료 중에 질병이 진행한 비소세포폐암 환자를 대상으로 한 공개라벨, 다중 약제, 생체표지자 중심, 다기관, 제II상, 우산형 임상시험(HUDSON)

MEDI4736

2

산업부, 실태조사결과 발표…고용인력 4만 1899명, 총생산 8조 9000억원
작년 국내 바이오산업 1조 9568억 원 투자…전년비 13.9% 증가

바이오의약품은 수출상위 품목 10위내에 6개를 차지하는 등 6개 품목의 수출액(1조 5,429억 원)이 총 수출의 34.7% 차지했다. 특히 바이오의약품 위탁생산․대행서비스의 수출액은 2,839억 원으로 전년 대비 311.4% 증가했다. 수입 역시 1조 4,606억 원을 기록하며 전년대비 3.7% 늘었다. 수입의 대부분은 바이오의약 품목이 1조 2,726억원으로 87%를 차지하는 가운데 치료용항체(21.4%)와 백신(31.9%)의 수입은 증가한 반면, 호르몬제(△39.2%), 혈액제제(△7.7%) 의 수입은 감소했다. 더불어 16년 기준 국내 바이오산업 고용 인력은 41,899명으로 2015년 대비 4.0% 증가했으며, 투자규모도 2016년 1조 9,568억 원으로 2015년 대비 13.9% 증가했다.....

■ 미국 인허가 현황

■ 미국 바이오의약품 임상 현황

Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

Metastatic Breast Cancer|HER2 Positive Breast Carcinoma

Drug: Niraparib|Drug: Trastuzumab

University of Alabama at Birmingham|Translational Breast Cancer Research Consortium|Tesaro, Inc.|Susan G. Komen Breast Cancer Foundation|Breast Cancer Research Foundation of Alabama

A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine/Oxaliplatin and Bevacizumab

Cancer - Metastatic Colorectal

Drug: ABT-165|Drug: Bevacizumab|Drug: Irinotecan|Drug: Leucovorin|Drug: Fluorouracil - bolus|Drug: Fluorouracil - infusion

Combination Pembrolizumab, Paclitaxel and Cisplatin in Patients With Cervical Cancer

Cervical Cancer

Drug: Pembrolizumab|Drug: Paclitaxel|Drug: Cisplatin

University of Miami

A Single Dose of Pembrolizumab in HIV-Infected People

Human Immunodeficiency Virus

Other: Placebo|Drug: Pembrolizumab

National Institutes of Health Clinical Center (CC)

A Phase II, Open-label, Single Arm Trial of Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma

MGMT-unmethylated Glioblastoma (GBM)|GBM

Drug: Nivolumab|Drug: Ipilimumab|Radiation: Radiation Therapy (RT)

New York University School of Medicine

Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer That Can Be Removed by Surgery

Non-Squamous Non-Small Cell Lung Carcinoma|Stage I Non-Small Cell Lung Cancer AJCC v7|Stage IA Non-Small Cell Lung Carcinoma AJCC v7|Stage IB Non-Small Cell Lung Carcinoma AJCC v7|Stage II Non-Small Cell Lung Cancer AJCC v7|Stage IIA Non-Small Cell Lung Carcinoma AJCC v7|Stage IIB Non-Small Cell Lung Carcinoma AJCC v7|Stage IIIA Non-Small Cell Lung Cancer AJCC v7

Biological: Nivolumab|Drug: Cisplatin|Drug: Pemetrexed Disodium|Drug: Gemcitabine Hydrochloride

Sidney Kimmel Cancer Center at Thomas Jefferson University|Bristol-Myers Squibb|Thomas Jefferson University

Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

Colorectal Cancer|Liver Metastases|Colorectal Adenocarcinoma|Colorectal Cancer With Hepatic Metastases|Colorectal Carcinoma

Drug: Floxuridine|Drug: Oxaliplatin|Drug: Leucovorin|Drug: 5-Fluorouracil|Drug: Irinotecan|Drug: Panitumumab

National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)

Ustekinumab (Anti-IL-12/23p40 Monoclonal Antibody) in Patients With Leukocyte Adhesion Deficiency Type 1 (LAD1) Who Have Inflammatory Pathology

Leukocyte Adhesion Deficiency Type 1

Biological: Ustekinumab

National Institute of Allergy and Infectious Diseases (NIAID)|National Institutes of Health Clinical Center (CC)

S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery

Colon Adenocarcinoma|ERBB2 Gene Amplification|Rectal Adenocarcinoma|Recurrent Colon Carcinoma|Recurrent Rectal Carcinoma|Stage III Colon Cancer AJCC v7|Stage III Rectal Cancer AJCC v7|Stage IIIA Colon Cancer AJCC v7|Stage IIIA Rectal Cancer AJCC v7|Stage IIIB Colon Cancer AJCC v7|Stage IIIB Rectal Cancer AJCC v7|Stage IIIC Colon Cancer AJCC v7|Stage IIIC Rectal Cancer AJCC v7|Stage IV Colon Cancer AJCC v7|Stage IV Rectal Cancer AJCC v7|Stage IVA Colon Cancer AJCC v7|Stage IVA Rectal Cancer AJCC v7|Stage IVB Colon Cancer AJCC v7|Stage IVB Rectal Cancer AJCC v7

Biological: Cetuximab|Drug: Irinotecan Hydrochloride|Other: Laboratory Biomarker Analysis|Biological: Pertuzumab|Biological: Trastuzumab|Device: HER-2 testing

Southwest Oncology Group|National Cancer Institute (NCI)

QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML

High-Risk Acute Myeloid Leukemia|Treatment-Related Acute Myeloid Leukemia|Secondary Acute Myeloid Leukemia|Myelodysplastic Syndrome

Masonic Cancer Center, University of Minnesota|University of Minnesota - Clinical and Translational Science Institute

4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer

HER2 Positive Breast Carcinoma|Recurrent Breast Carcinoma|Stage III Breast Cancer|Stage IIIA Breast Cancer|Stage IIIB Breast Cancer|Stage IIIC Breast Cancer|Stage IV Breast Cancer

Drug: Utomilumab|Drug: Trastuzumab|Drug: Trastuzumab Emtansine

George W. Sledge Jr.|National Cancer Institute (NCI)|Stanford University

A Pilot Study of a Personalized Neoantigen Cancer Vaccine Following Front-Line Rituximab in Follicular Lymphoma

Follicular Lymphoma

Drug: Rituximab|Biological: Neo Vax

Dana-Farber Cancer Institute

Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma (KarMMa)

Multiple Myeloma

An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

Advanced Cancer

Biological: BMS-986249|Biological: Nivolumab

Bristol-Myers Squibb

PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer

Triple Negative Breast Cancer|Metastatic Breast Cancer

Drug: Pembrolizumab|Biological: PVX-410

Massachusetts General Hospital|Merck Sharp & Dohme Corp.

A Study of LY3209590 in Participants With Type 2 Diabetes

Diabetes Mellitus, Type 2

Drug: LY3209590|Drug: Insulin Glargine

Eli Lilly and Company

Naxitamab for Neuroblastoma With Osteomedullary Disease

Neuroblastoma

Biological: GM-CSF + hu3F8

Y-mAbs Therapeutics

■ 유럽 바이오의약품 임상 현황

Nivolumab With Gemcitabine, Oxaliplatin + Rituximab in r/r Elderly Lymphoma Patients

Lymphoma, Non-Hodgkin

Drug: Nivolumab|Drug: Rituximab|Drug: Gemcitabine|Device: Oxaliplatin

University Hospital, Saarland|Bristol-Myers Squibb|Lymphoma Study Association|University of Leipzig

GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial)

Diabetes Mellitus, Type 1

Drug: Oral Insulin|Other: Placebo

Technische Universität München|The Leona M. and Harry B. Helmsley Charitable Trust|Helmholtz Zentrum München|University Hospital Carl Gustav Carus|Kinderkrankenhaus auf der Bult|Skane University Hospital|Universitaire Ziekenhuizen Leuven|Medical University of Warsaw|University of Oxford, Clinical Vaccine Research and Immunisation Education

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT

Multiple Sclerosis

Drug: Alemtuzumab GZ402673|Drug: Glatiramer acetate|Drug: Beta-Interferon|Drug: Methylprednisolone|Drug: Ranitidine|Drug: Ceterizine|Drug: Dexchlorpheniramine|Drug: Paracetamol|Drug: Acyclovir|Drug: Prednisolone

Genzyme, a Sanofi Company|Sanofi

Naxitamab for Neuroblastoma With Osteomedullary Disease

Neuroblastoma

Biological: GM-CSF + hu3F8

Y-mAbs Therapeutics