Biogeneric versus Biosimilar Products

US Food and Drug Administration. Fact sheet: issuance of draft guidances on biosimilars product development. February 2012. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm291197.htm. Accessed August 29, 2012.

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 August 29, 2012.

US Food and Drug Administration (Docket No. FDA-2011-D0611). Draft guidance for industry on biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009: availability. Federal Register. 2012; 77(31): 8885–8886.

US Food and Drug Administration. Questions and answers: issuance of three draft guidance documents on biosimilars product development. February 2012. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm291186.htm. Accessed August 29, 2012.

US Food and Drug Administration. Can you tell us about the FDA's position on biosimilars? August 2012. http://www.fda.gov/Drugs/NewsEvents/ucm317210.htm. Accessed August 29, 2012.

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Chow S.C. Endrenyi L. Lachenbruch P.A. Comments on the FDA draft guidance on biosimilars products [published online ahead of print August 18, 2012]. Stat Med. doi 10.1002/sim.5572.

Chow S.C. Yang L.Y. Starr A. Chiu S.T. Statistical methods for assessing interchangeability of biosimilars [published online ahead of print August 17, 2012]. Stat Med. doi 10.1002/sim.5566.

US Food and Drug Administration. FDA approval: BLA 125294 – tbo-filgrastim. Drugs@FDA. August 29, 2012. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails) Accessed August 31, 2012.

FDA approves short-acting neutropenia drug. MedPage Today. August 30, 2012. http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/34488. Accessed August 31, 2012.

Abolfazli R. Hosseini A. Gholami Kh. Javadi M.R. Torkamandi H. Emami S. Quality of life assessment in patients with multiple sclerosis receiving interferon beta-1a: a comparative longitudinal study of Avonex and its biosimilars CinnoVex [published online ahead of print August 9, 2012]. ISRN Neurol. 2012; 786526.