First Trastuzumab Biosimilar, Ogivri, Approved by FDA

(FDA News Release, December 1, 2017)

3 Facts About Biosimilars Pharmacists Should Know

Pharmacy Times (03/08/16) Ross, Meghan

AGA Survey Reveals Respondents' Views on Biosimilar Drugs

American Gastroenterological Association (07/30/15)

Amgen Files for U.S. Approval of Biosimilar to Humira

Reuters (11/25/15) Berkrot, Bill

Amgen Loses Bid to Block a Biosimilar Version of Its Best-Selling Drug

Wall Street Journal (03/20/15) Silverman, Ed

Amgen Presents Detailed Results From Phase 3 Study Demonstrating Clinical Equivalence Of Biosimilar Candidate ABP 501 With Adalimumab

PipelineReview.com (11/10/15)

Amgen's Humira Biosimilar Accepted for FDA Review

Bloomberg BNA (01/26/16) Aquino, John T.

ASBM Releases Pharmacist Survey; Findings Show Strong Support for Distinguishable Names for Biologics and Need for Transparency in Labeling

PR Newswire (10/13/15)

Assessment of Pharmacists' Views on Biosimilar Naming Conventions

Journal of Managed Care & Specialty Pharmacy (03/01/15) Vol. 21, No. 3, P. 188; Fernandez-Lopez, Sara; Kazzaz, Denise; Bashir, Mohamed

Benepali, the First Etanercept Biosimilar Referencing Enbrel, Approved in the European Union

Business Wire (01/16/16)

Biosimilar Approval Brings New Awareness Levels for Community Pharmacists

Pharmacy Times (04/15/15) Oldfield, Eileen

Biosimilar Competition in the United States: Statutory Incentives, Payers, and Pharmacy Benefit Managers

Health Affairs (Quarter 1, 2015) Vol. 34, No. 2, P. 294; Falit, Benjamin P.; Singh, Surya C.; Brennan, Troyen A.

Biosimilar Issues on the FDA Guidance Agenda for 2016

U.S. Food and Drug Administration (01/22/2016)

Biosimilar Monoclonal Antibodies: The Scientific Basis for Extrapolation

Expert Opinion on Biological Therapy (09/15) P. 1; Schellekens, H.; Lietzan, E.; Faccin, F.

Biosimilar Safety Factors in Clinical Practice

Seminars in Arthritis & Rheumatism (06/01/2015) Vol. 44, Reinisch, W.; Smolen, J.

Biosimilar Therapies in Inflammatory Bowel Disease: Should We Care About Patient Profile?

Expert Review of Clinical Immunology (02/16) Fiorino, Gionata; Fazio, Maria; Danese, Silvio

Biosimilar: What It Is Not

British Journal of Clinical Pharmacology (04/11/15) de Mora, Fernand

Biosimilarity Versus Manufacturing Change: Two Distinct Concepts

Pharmaceutical Research (09/17/2015) Declerck, P.; Farouk-Rezk, M.; Rudd, P.M.

Biosimilars Forum Expresses Concern With CMS Proposed Rule on Biosimilar Payment and Coding

Biosimilars Forum (07/09/15)

Biosimilars in Development Near End of Phase 3 Trials

Managed Care (02/01/16) Adams, Katherine T.