Call for Papers:Vol.10 Issue.6

Submission
Last date		 30-Dec-2024
Acceptance Status In One Day
Paper Publish In Two Days
Submit ManuScript

News & Updates

Submit Article

Dear Authors, Article publish in our journal for Volume-10,Issue-6. For article submission on below link: Submit Manuscript


Join As Board

Dear Reviewer, You can join our Reviewer team without given any charges in our journal. Submit Details on below link: Join As Board


Paper Publication Charges

IJARIIE APP
Download Android App

For Authors

Archives

IJARIIE Board

Downloads

Android App

Download IJARIIE APP

Authors

Title: :  CHALLENGES AND OPPORTUNITIES IN REGULATORY AFFAIRS: BIOTHERAPEUTICS, BIOLOGICS, BIOSIMILARS AND BIOBETTERS.
PaperId: :  20257
Published in:   International Journal Of Advance Research And Innovative Ideas In Education
Publisher:   IJARIIE
e-ISSN:   2395-4396
Volume/Issue:    Volume 9 Issue 3 2023
DUI:    16.0415/IJARIIE-20257
Licence: :   IJARIIE is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.

Author NameAuthor Institute
Mansi Maruti DurgudeSamarth College of Pharmacy, Belhe, Maharashtra, India.
Chandrabhaga Dnyandev GaikwadSamarth College of Pharmacy, Belhe, Maharashtra, India.
Siddhi Shivaji BorhadeSamarth College of Pharmacy, Belhe, Maharashtra, India.
Gayatri Vikas KordeSamarth College of Pharmacy, Belhe, Maharashtra, India.
Aparna Ashok KaleSamarth College of Pharmacy, Belhe, Maharashtra, India.
Nilesh Mahadev GoradSamarth College of Pharmacy, Belhe, Maharashtra, India.
Ashwini Balasaheb GaikwadSamarth College of Pharmacy, Belhe, Maharashtra, India.

Abstract

B. Pharmacy
Biologics, skills, challenges, regulatory affairs, Biosimilars, legal, development, agencies, therapeutics.
A shortened Food and Drug Administration approval process for biosimilar medicines that are more affordable and very comparable to the reference biological product but not identical. Fewer biosimilars are anticipated to enter the biologics industry than generic pharmaceuticals did when they first entered the small-molecule medication market since bringing biosimilars to market currently demands large financial commitments. Furthermore, subject to changing state substitution laws, most biosimilars will likely compete as therapeutic alternatives rather than as therapeutic equivalents due to the high regulatory hurdles to obtaining interchangeability, which would allow pharmacists to substitute a biosimilar for its reference product. In other words, in order to compete with their reference product, biosimilars must offer superior quality, lower prices, and a producer with a solid reputation among medical professionals, insurers, and patient groups. The development of novel biologics in the same therapeutic class, such as "biobetters," which provide minor upgrades over reference medicines like a longer duration of action, will also pose a significant threat to the viability of biosimilars. For the foreseeable future, it seems like there won't be many large cost savings from using biosimilars, but supply and demand-side variables should eventually lead to a rise in their utilization.

Citations

Copy and paste a formatted citation or use one of the links to import into a bibliography manager and reference.

IJARIIE Mansi Maruti Durgude, Chandrabhaga Dnyandev Gaikwad, Siddhi Shivaji Borhade, Gayatri Vikas Korde, Aparna Ashok Kale, Nilesh Mahadev Gorad, and Ashwini Balasaheb Gaikwad. "CHALLENGES AND OPPORTUNITIES IN REGULATORY AFFAIRS: BIOTHERAPEUTICS, BIOLOGICS, BIOSIMILARS AND BIOBETTERS." International Journal Of Advance Research And Innovative Ideas In Education Volume 9 Issue 3 2023 Page 1311-1325
MLA Mansi Maruti Durgude, Chandrabhaga Dnyandev Gaikwad, Siddhi Shivaji Borhade, Gayatri Vikas Korde, Aparna Ashok Kale, Nilesh Mahadev Gorad, and Ashwini Balasaheb Gaikwad. "CHALLENGES AND OPPORTUNITIES IN REGULATORY AFFAIRS: BIOTHERAPEUTICS, BIOLOGICS, BIOSIMILARS AND BIOBETTERS.." International Journal Of Advance Research And Innovative Ideas In Education 9.3(2023) : 1311-1325.
APA Mansi Maruti Durgude, Chandrabhaga Dnyandev Gaikwad, Siddhi Shivaji Borhade, Gayatri Vikas Korde, Aparna Ashok Kale, Nilesh Mahadev Gorad, & Ashwini Balasaheb Gaikwad. (2023). CHALLENGES AND OPPORTUNITIES IN REGULATORY AFFAIRS: BIOTHERAPEUTICS, BIOLOGICS, BIOSIMILARS AND BIOBETTERS.. International Journal Of Advance Research And Innovative Ideas In Education, 9(3), 1311-1325.
Chicago Mansi Maruti Durgude, Chandrabhaga Dnyandev Gaikwad, Siddhi Shivaji Borhade, Gayatri Vikas Korde, Aparna Ashok Kale, Nilesh Mahadev Gorad, and Ashwini Balasaheb Gaikwad. "CHALLENGES AND OPPORTUNITIES IN REGULATORY AFFAIRS: BIOTHERAPEUTICS, BIOLOGICS, BIOSIMILARS AND BIOBETTERS.." International Journal Of Advance Research And Innovative Ideas In Education 9, no. 3 (2023) : 1311-1325.
Oxford Mansi Maruti Durgude, Chandrabhaga Dnyandev Gaikwad, Siddhi Shivaji Borhade, Gayatri Vikas Korde, Aparna Ashok Kale, Nilesh Mahadev Gorad, and Ashwini Balasaheb Gaikwad. 'CHALLENGES AND OPPORTUNITIES IN REGULATORY AFFAIRS: BIOTHERAPEUTICS, BIOLOGICS, BIOSIMILARS AND BIOBETTERS.', International Journal Of Advance Research And Innovative Ideas In Education, vol. 9, no. 3, 2023, p. 1311-1325. Available from IJARIIE, https://ijariie.com/AdminUploadPdf/CHALLENGES_AND_OPPORTUNITIES_IN_REGULATORY_AFFAIRS__BIOTHERAPEUTICS__BIOLOGICS__BIOSIMILARS_AND_BIOBETTERS__ijariie20257.pdf (Accessed : ).
Harvard Mansi Maruti Durgude, Chandrabhaga Dnyandev Gaikwad, Siddhi Shivaji Borhade, Gayatri Vikas Korde, Aparna Ashok Kale, Nilesh Mahadev Gorad, and Ashwini Balasaheb Gaikwad. (2023) 'CHALLENGES AND OPPORTUNITIES IN REGULATORY AFFAIRS: BIOTHERAPEUTICS, BIOLOGICS, BIOSIMILARS AND BIOBETTERS.', International Journal Of Advance Research And Innovative Ideas In Education, 9(3), pp. 1311-1325IJARIIE [Online]. Available at: https://ijariie.com/AdminUploadPdf/CHALLENGES_AND_OPPORTUNITIES_IN_REGULATORY_AFFAIRS__BIOTHERAPEUTICS__BIOLOGICS__BIOSIMILARS_AND_BIOBETTERS__ijariie20257.pdf (Accessed : )
IEEE Mansi Maruti Durgude, Chandrabhaga Dnyandev Gaikwad, Siddhi Shivaji Borhade, Gayatri Vikas Korde, Aparna Ashok Kale, Nilesh Mahadev Gorad, and Ashwini Balasaheb Gaikwad, "CHALLENGES AND OPPORTUNITIES IN REGULATORY AFFAIRS: BIOTHERAPEUTICS, BIOLOGICS, BIOSIMILARS AND BIOBETTERS.," International Journal Of Advance Research And Innovative Ideas In Education, vol. 9, no. 3, pp. 1311-1325, May-Jun 2023. [Online]. Available: https://ijariie.com/AdminUploadPdf/CHALLENGES_AND_OPPORTUNITIES_IN_REGULATORY_AFFAIRS__BIOTHERAPEUTICS__BIOLOGICS__BIOSIMILARS_AND_BIOBETTERS__ijariie20257.pdf [Accessed : ].
Turabian Mansi Maruti Durgude, Chandrabhaga Dnyandev Gaikwad, Siddhi Shivaji Borhade, Gayatri Vikas Korde, Aparna Ashok Kale, Nilesh Mahadev Gorad, and Ashwini Balasaheb Gaikwad. "CHALLENGES AND OPPORTUNITIES IN REGULATORY AFFAIRS: BIOTHERAPEUTICS, BIOLOGICS, BIOSIMILARS AND BIOBETTERS.." International Journal Of Advance Research And Innovative Ideas In Education [Online]. volume 9 number 3 ().
Vancouver Mansi Maruti Durgude, Chandrabhaga Dnyandev Gaikwad, Siddhi Shivaji Borhade, Gayatri Vikas Korde, Aparna Ashok Kale, Nilesh Mahadev Gorad, and Ashwini Balasaheb Gaikwad. CHALLENGES AND OPPORTUNITIES IN REGULATORY AFFAIRS: BIOTHERAPEUTICS, BIOLOGICS, BIOSIMILARS AND BIOBETTERS.. International Journal Of Advance Research And Innovative Ideas In Education [Internet]. 2023 [Cited : ]; 9(3) : 1311-1325. Available from: https://ijariie.com/AdminUploadPdf/CHALLENGES_AND_OPPORTUNITIES_IN_REGULATORY_AFFAIRS__BIOTHERAPEUTICS__BIOLOGICS__BIOSIMILARS_AND_BIOBETTERS__ijariie20257.pdf
BibTex EndNote RefMan RefWorks

Number Of Downloads



Save in Google Drive

Similar-Paper

TitleArea of ResearchAuther NameAction
A comprehensive review on Flaxseeds: Nutritional profile, food uses and health benefitsPharmacyMs. Samruddhi Rajpure Download
A comprehensive review on Enicostemma Littorale Blume as an Ayurvedic HerbPharmacyMr. Prasad Bhopale Download
REVIEW ON SHANKHPUSHPI IN NEUROLOGICAL DISORDERSpharmacognosyAbhilash Kutlehria Download
"MARFAN SYNDROME: A COMPREHENSIVE GUIDE TO PATHOGENESIS, DIAGNOSIS, TREATMENT AND MEDICAL MANAGEMENT"Pharmacy Vishvajit Bharat Waghmare Download
To Study On Etiology, Symptoms, Diagnosis ,Treatment and Therapeutic Outcome Of ‘DENGUE FEVER’PHARMACYMELAM.YESURATNAM Download
A review on Nutritional requirements during pregnancyPharmacy Rode Nikita Shivaji Download
DEVELOPMENT AND CHARACTERIZATION OF ORAL MICRO-PARTICULATE DRUG DELIVERY SYSTEMPharmacyAbhilashkutlehria Download
Composition and Analyzation of Transdermal Diclofenac Sodium PatchesPharmacyAbhilash Kutlehria Download
A REVIEW ON HERBAL MEDICINE PLANTS ARE USED FOR THE TREATMENT OF EYE DISORDERS.PHARMACYManoj AN Download
Validation of Sitagliptin Phosphate & Simvastatin by RP-HPLCPharmaceutical Science Sahil Ravindra Chavhan Download
Method Development and Validation of Kaempferol by using High Performance Liquid ChromatographyPharmacyReena Nanasaheb Autade Download
Cheilocostus Speciosus Traditional Uses And TaxonomyPharmacyRajat Kumar Download
Evaluation of Medicinal Plants for Their Therapeutic Potential in Wound ManagementM. Pharmacy (Pharmacology)Aniket Dhadwal Download
A PROSPECTIVE REVIEW ON TRANSETHASOMAL GEL AS CARRIER FOR ENHANCING TRANSDERMAL DELIVERYPharmaceutical FormulationMohammad amin Yatoo Download
FORMULATION AND EVALUATION OF POLY HERBAL FACE MASKpharmacyVANASHRI TURKE Download
12