PDF-Scientific Considerations in Demonstrating Biosimilarity to a Reference Product DRAFT

574115745557453574535744557454574605745957376574415745457444573765745957461574475744757445574595746057449574555745457459573765745857445574475744157458574445744957454574475737657460574485744957459573765744457458574415744657460573765744457455574435746. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the not ice announcing the availa bility of the draft guidance Submit electronic comments to httpwwwregulationsgov S Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic com ments to httpwwwregulationsgov Su Comments and suggestions regarding this draft document should be subm itted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management H Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Submit written Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management HF Com ents and suggestio ns regar ing this draft do cu ent should be sub itted wit in 9 0 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Subm it comments to the D ivision of Dockets Manage e Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER April 2015 Biosimilarity brPage 2br Quality Considerations in Demonstrating Biosimi Conferences. Conference Series LLC . is a pioneer and leading science event organizer, which publishes around 500 open access journals and conducts over 500 Medical, Clinical, Engineering, Life Sciences, Pharma scientific conferences all over the globe annually with the support of more than 1000 scientific associations and 30,000 editorial board members and 3.5 million followers to its credit.. OMICS Group Biosimilars 2015 Birmingham, UK. 10-11 Aug 2015. Hazel Gorham . GorhamHazel@prahs.com. Topics. What is a Biosimilar and Why?. Demonstrating Similarity . Quality attributes. Non-clinical animal. OMIC Group Biosimilars 2014. Hyderabad India. 27-29 Oct 2014. Rodeina Challand. ChallandRodeina@prahs.com. Global Biosimilar Concept. Generic approach is not appropriate. Step-wise comparability approach. G:\5412dft.doc01/02/03 G:\5412dft.doc01/02/03 The Division of Drug Information (HFD-240)Center for Drug Evaluation and Research (Tel) 301-827-4573 Draft — Not for ImplementationG:\5412dft.doc01/0