Literature DB >> 25946143

Progress and Hurdles for Follow-on Biologics.

Ameet Sarpatwari1, Jerry Avorn, Aaron S Kesselheim.   

Abstract

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Year:  2015        PMID： 25946143     DOI： 10.1056/NEJMp1504672

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  13 in total

1.  Mind the Gap: Why Closing the Doughnut Hole Is Insufficient for Increasing Medicare Beneficiary Access to Oral Chemotherapy.

Authors:  Stacie B Dusetzina; Nancy L Keating
Journal:  J Clin Oncol       Date:  2015-12-07       Impact factor: 44.544

2.  Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

Authors:  Aaron S Kesselheim; Joshua J Gagne
Journal:  Drug Saf       Date:  2015-10       Impact factor: 5.606

Review 3.  Differentiating biosimilarity and comparability in biotherapeutics.

Authors:  Valderilio Azevedo; Brian Hassett; João Eurico Fonseca; Tatsuya Atsumi; Javier Coindreau; Ira Jacobs; Ehab Mahgoub; Julie O'Brien; Ena Singh; Steven Vicik; Brian Fitzpatrick
Journal:  Clin Rheumatol       Date:  2016-10-12       Impact factor: 2.980

4.  FDA and EMA Biosimilar Approvals.

Authors:  Emily H Jung; Ameet Sarpatwari; Aaron S Kesselheim; Michael S Sinha
Journal:  J Gen Intern Med       Date:  2019-10-21       Impact factor: 5.128

Review 5.  Established and Emerging Immunological Complications of Biological Therapeutics in Multiple Sclerosis.

Authors:  Babak Soleimani; Katy Murray; David Hunt
Journal:  Drug Saf       Date:  2019-08       Impact factor: 5.606

6.  Patient attitudes and understanding about biosimilars: an international cross-sectional survey.

Authors:  Ira Jacobs; Ena Singh; K Lea Sewell; Ahmad Al-Sabbagh; Lesley G Shane
Journal:  Patient Prefer Adherence       Date:  2016-05-26       Impact factor: 2.711

Review 7.  What do oncologists need to know about biosimilar products?

Authors:  Linda K S Leung; Kevin Mok; Calvin Liu; Stephen L Chan
Journal:  Chin J Cancer       Date:  2016-10-13

Review 8.  Evolving trends in mAb production processes.

Authors:  Abhinav A Shukla; Leslie S Wolfe; Sigma S Mostafa; Carnley Norman
Journal:  Bioeng Transl Med       Date:  2017-04-03

9.  Assessment of Variation in State Regulation of Generic Drug and Interchangeable Biologic Substitutions.

Authors:  Chana A Sacks; Victor L Van de Wiele; Lisa A Fulchino; Lajja Patel; Aaron S Kesselheim; Ameet Sarpatwari
Journal:  JAMA Intern Med       Date:  2021-01-01       Impact factor: 21.873

Review 10.  A Single-use Strategy to Enable Manufacturing of Affordable Biologics.

Authors:  Renaud Jacquemart; Melissa Vandersluis; Mochao Zhao; Karan Sukhija; Navneet Sidhu; Jim Stout
Journal:  Comput Struct Biotechnol J       Date:  2016-07-05       Impact factor: 7.271
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