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Call for Papers:Vol.11 Issue.4

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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.

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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
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