Biosimilars in India; Current Status and Future Perspectives

被引：21
作者：
Meher, Bikash R. [1 ]
Balan, Sakthi [2 ]
Mohanty, Rashmi R. [3 ]
Jena, Monalisa [1 ]
Das, Smita [4 ,5 ]
机构：
[1] All India Inst Med Sci, Dept Pharmacol, Bhubaneswar, Odisha, India
[2] Srivenkateshwaraa Med Coll Hosp & Res Ctr, Dept Pharmacol, Pondicherry, India
[3] All India Inst Med Sci, Dept Gen Med, Bhubaneswar, Odisha, India
[4] Inst Med Sci, Dept Pharmacol, Bhubaneswar, Odisha, India
[5] Sum Hosp, Bhubaneswar, Odisha, India
来源：
JOURNAL OF PHARMACY AND BIOALLIED SCIENCES | 2019年 / 11卷 / 01期
关键词：
Biosimilars; European Medicines Agency; Food and Drug Administration; similar biologics; BIOLOGICS; INSULIN;
D O I：
10.4103/jpbs.JPBS_167_18
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
Many key biologics are scheduled to lose their patent by the year 2020, which will provide the opportunity to other biopharmaceutical companies to develop the similar biologics. Biosimilar or similar biologic used has increased in the recent year following the approval of the first biosimilar in early 2000. India is one of the leading manufacturers of similar biologics. India has developed a new guideline in 2012 for the pre- and post-marketing approval of similar biologics.
引用
收藏
页码：12 / 15
页数：4
相关论文
共 50 条
  • [11] Current and future roles of biosimilars in oncology practice (Review)
    Konstantinidou, Sofia
    Papaspiliou, Angeliki
    Kokkotou, Eleni
    ONCOLOGY LETTERS, 2020, 19 (01) : 45 - 51
  • [12] Oral Insulin: Current Status, Challenges, and Future Perspectives
    Chellappan, Dinesh Kumar
    Yenese, Yap
    Wei, Chew Chian
    Chellian, Jestin
    Gupta, Gaurav
    JOURNAL OF ENVIRONMENTAL PATHOLOGY TOXICOLOGY AND ONCOLOGY, 2017, 36 (04) : 283 - 291
  • [13] Overview of Humira® Biosimilars: Current European Landscape and Future Implications
    Coghlan, Jill
    He, Hongliang
    Schwendeman, Anna S.
    JOURNAL OF PHARMACEUTICAL SCIENCES, 2021, 110 (04) : 1572 - 1582
  • [14] Small intestine-targeted endoscopic bariatrics: Current status and future perspectives
    Ren, Mengting
    Ji, Feng
    DIGESTIVE ENDOSCOPY, 2023, 35 (06) : 684 - 697
  • [15] Genetic Testing of Maturity-Onset Diabetes of the Young Current Status and Future Perspectives
    Firdous, Parveena
    Nissar, Kamran
    Ali, Sajad
    Ganai, Bashir Ahmad
    Shabir, Uzma
    Hassan, Toyeeba
    Masoodi, Shariq Rashid
    FRONTIERS IN ENDOCRINOLOGY, 2018, 9
  • [16] Biosimilars in Oncology: Latest Trends and Regulatory Status
    Joshi, Deeksha
    Khursheed, Rubiya
    Gupta, Saurabh
    Wadhwa, Diksha
    Singh, Thakur Gurjeet
    Sharma, Sumit
    Porwal, Sejal
    Gauniyal, Swati
    Vishwas, Sukriti
    Goyal, Sanjay
    Gupta, Gaurav
    Eri, Rajaraman D.
    Williams, Kylie A.
    Dua, Kamal
    Singh, Sachin Kumar
    PHARMACEUTICS, 2022, 14 (12)
  • [17] Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting System
    Singh, Abhishek
    Kalaivani, Muthusamy
    Srivastava, Sushma
    Goyal, Ramesh K.
    Gupta, Suresh K.
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020, 54 (03) : 667 - 680
  • [18] Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting System
    Singh, Abhishek
    Kalaivani, Muthusamy
    Srivastava, Sushma
    Goyal, Ramesh K.
    Gupta, Suresh K.
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2019,
  • [19] Biomedical Applications of Polymeric Microneedles for Transdermal Therapeutic Delivery and Diagnosis: Current Status and Future Perspectives
    Liu, Tengfei
    Luo, Gaoxing
    Xing, Malcolm
    ADVANCED THERAPEUTICS, 2020, 3 (09)
  • [20] Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting System
    Abhishek Singh
    Muthusamy Kalaivani
    Sushma Srivastava
    Ramesh K. Goyal
    Suresh K. Gupta
    Therapeutic Innovation & Regulatory Science, 2020, 54 : 667 - 680
12345