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1. www.ncbi.nlm.nih.gov › pmc › articlesRegulatory challenges with biosimilars: an update from 20 ...

   www.ncbi.nlm.nih.gov › pmc › articles

   Nov 21, 2020 · Despite this effort, a recent WHO survey (conducted in 2019–2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and naming...

   • Biosimilars: Review of current applications, obstacles, and ...

     Additional data confirming the safety and efficacy of...

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3. www.ncbi.nlm.nih.gov › pmc › articlesAn Overview of Biosimilars—Development, Quality, Regulatory ...

   www.ncbi.nlm.nih.gov › pmc › articles

   Feb 11, 2024 · Recognizing the inherent complexities of comprehending biosimilars fully, it is essential to focus on realistic approaches, such as fostering open communication between healthcare providers and patients, encouraging informed decision-making, and minimizing risks.

   • DOI: 10.3390/ph17020235

   • Published: 2024/02

4. www.centerforbiosimilars.com › view › biosimilarsBiosimilars: Issues, Challenges, and Strategy for Success

   www.centerforbiosimilars.com › view › biosimilars

   • Cached

   Sep 12, 2017 · The class of biosimilar medicines has emerged as a potential solution across the globe, providing an answer to the ever-expanding expenses of biologics.

5. pubmed.ncbi.nlm.nih.gov › 33222245Regulatory challenges with biosimilars: an update from 20 ...

   pubmed.ncbi.nlm.nih.gov › 33222245

   Despite this effort, a recent WHO survey (conducted in 2019-2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and ...

   • Author: Hye Na Kang, Robin Thorpe, Ivana Knezevic, Mary Casas Levano, Mumbi Bernice Chilufya, Parichard Chir...

   • Publish Year: 2021

6. www.ncbi.nlm.nih.gov › pmc › articlesBiosimilars: Review of current applications, obstacles, and ...

   www.ncbi.nlm.nih.gov › pmc › articles

   Aug 8, 2018 · Additional data confirming the safety and efficacy of biosimilars, increased number of available biosimilars, and further cost reduction of biosimilars will all be necessary to improve physician confidence in biosimilars and patient comfort with biosimilars.

   • Author: Flyn Kaida-Yip, Kaivalya Deshpande, Trishla Saran, Dinesh Vyas

   • Publish Year: 2018

7. www.topra.org › topra › topra_memberRegulatory complexities and challenges of biosimilars

   www.topra.org › topra › topra_member

   speculation and excitement on the potential for biosimilars with increasingly complex structures, eg, multi-subunit, extensively post-translationally modified, and lipid-containing products. KEYWORDS: Biopharmaceutical; Biosimilars; Switching/interchangeability; Similarity; Data requirements; Clinical development.

8. People also ask

   What are the challenges faced by biosimilars?

   • The field of biosimilars so far presents some considerable challenges, namely, regulatory, safety, economic, and legal which are still being debated and discussed in different forums. In this article, w e have tried to summarize the general principles and

   (PDF) BIOSIMILARS: OPPORTUNITIES, CHALLENGES, AND THE ... - Resea…

   www.researchgate.net/publication/356851296_BIOSIMILARS_OPPORTUNITIES_CHALLENGES_AND_THE_GENERAL_PRINCIPLES_GOVERNING_THEIR_DEVELOPMENT_AROUND_THE_GLOBE

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   What challenges could prevent biosimilar entry into an already tightly-held market?

   • Lastly, patient assistance programs and indigent patient programs would need to be at par with reference products. To summarize, several challenges could prevent biosimilar entry into an already tightly-held market, prompting strategic thinking, careful planning, and clear implementation policies.

   Biosimilars: Issues, Challenges, and Strategy for Success

   www.centerforbiosimilars.com/view/biosimilars-issues-challenges-and-strategy-for-success

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   Should biosimilars be labeled?

   • There has been much discussion on naming and labeling biosimilars, but to date, there is no consensus. This could potentially lead to problems with identifying products and pharmacovigilance unless careful attention is paid to the issue.

   Regulatory challenges with biosimilars: an update from 20 countries - P…

   www.ncbi.nlm.nih.gov/pmc/articles/PMC8247359/

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   Can biosimilars be used in clinical practice?

   • Increasing numbers of biosimilars are now available for use in clinical practice, and physicians, other prescribers, and patients are all challenged to become familiar with the advantages of the clinical use of biosimilars.

   Regulatory challenges with biosimilars: an update from 20 countries - P…

   www.ncbi.nlm.nih.gov/pmc/articles/PMC8247359/

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9. www.researchgate.net › publication › 356851296BIOSIMILARS: OPPORTUNITIES, CHALLENGES, AND THE GENERAL ...

   www.researchgate.net › publication › 356851296

   Nov 12, 2021 · Outstanding issues include the interchangeability of biosimilars and innovator products, the possible need for unique naming to differentiate the various biopharmaceutical products, and more ...