What is your Institution's Position Going to be on Biosimilars?

FDA approves first biosimilar product Zarxio. US Food and Drug Administration. March 6, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm. Accessed April 20, 2015.

Background information: Lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations (Purple Book). US Food and Drug Administration. March 5, 2015. http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411424.htm. Accessed April 20, 2015.

Lucio S. , McBride A. Biosimilars 101: The science, approval process, and implications for your practice. Hosp Pharm. 2015; 49(Suppl 1): S1–S12.

A health-system pharmacist's guide to biosimilars: Regulatory, scientific, and practical considerations: A discussion guide for health-system pharmacists on biosimilars. ASHP Advantage & www.biosimcentral.org. 2013. http://www.ashpadvantage.com/biosimcentral/docs/biosimcentral_guidelines.pdf. Accessed April 20, 2015.

Fact sheet: Issuance of draft guidances on biosimilars product development. US Food and Drug Administration. February 2012. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm291297.htm. Accessed April 20, 2015.

Sherman R.E. Biosimilar biological products. Biosimilar guidance Webinar handout. February 15, 2012. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM292463.pdf. Accessed April 20, 2015

Questions and answers: Issuance of three draft guidance documents on biosimilars product development. US Food and Drug Administration. February 2012. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm291286.htm. Accessed April 20, 2015.

Liang B.A. , Mackey T. Biosimilars and patient safety risk: Promoting policy protections in the health delivery system. Rev Health Care. 2012; 3(2): 71–74.

Declerck P.J. Biologicals and biosimilars: A review of the science and its implications. Generics Biosimilars Initiative J. 2012; 1(1): 13–16.

Strober B.E. , Armour K. , Romiti R. Biopharmaceuticals and biosimilars in psoriasis: What the dermatologist needs to know. J Am Acad Dermatol. 2012; 66: 317–322.

Chow S.C. Scientific issues for assessing biosimilars in the United States. Biomet Biostat. 2012; 3(3): 1000e107.

Chow S.C. , Yang L.Y. , Starr A. , Chiu S.T. Statistical methods for assessing interchangeability of biosimilars. Stat Med. 2012. doi 10.1002/sim.5566.

Biosimilars: More treatment options are on the way. US Food and Drug Administration. March 5, 2015. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm436399.htm. Accessed April 20, 2015.

Lucio S.D. , Stevenson J.G. , Hoffman J.M. Biosimilars: Implications for health-system pharmacists. Am J Health Syst Pharm. 2013; 70: 2004–2017.

Biosimilars. Part 2: Potential concerns and challenges for P&T Committees. P&T. 2013; 38(6): 329–335.

Griffith N. , McBride A. , Stevenson J.G. , Green L. Formulary selection criteria for biosimilars: Considerations for the US health-system pharmacists. Hosp Pharm. 2014; 49(9): 813–825.

Blank C. How pharmacists can keep up with biosimilar approvals. Drug Topics. April 10, 2015. (http://drugtopics.modernmedicine.com/drug-topics/news/how-pharmacists-can-keep-biosimilar-approvals. Accessed April 20, 2015.