FDA Biosimilars and Interchangeable Biosimilars Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed

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Biosimilars and Interchangeable Biosimilars Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed[附网盘链接]是于过去发布的FDA标准，适用于US。

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Draft—Not for Implementation 1 Biosimilars and Interchangeable Biosimilars: Lier censure for Few

2 Than All Conditihich the Refons of Use for Werence Product Has 3 Been Licensed 1 4 Guidance for Industry 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency blish any rights ) on thi s topic. It does not estafor any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 15 I. INTRODUCTION 16 17 This guidance provides recommcensure under seendations to applicants seeking liction 351(k) of 18 the Public Health Service (PHS) Act of a proposed biosimilar or proposed interchangeable 2

19 biosim for fewer than all of the refilar erence product’s licensed conditions of use. This 20 guidance also provides recommendations on the submission of a supplement to a licensed 351(k) 21 biologics license application (BLA) seeking to add a condition of use that previously has been 3 4

22 licen for the reference product to the labelingsed of a licensed biosimr or interchangilaeable 23 product, including considerations related to the tim submissions. ing of such

24 25 This guidance includes recommspecific issuesendations regarding the following : 26 27  Submission of an application seeking licensure of a proposed biosimilar or proposed 28 interchangeable bioswer than all of the reference imilar fproduct’s licensed conditions of or fe

29 use. 1 Thi s draft guidance has beenaluation and Researc prepared ERby) a tnd the Che Chent (CDeentr er for for Drug Ev

Biologics Evalu (ation and ResCBER) at the Fodearchmodin andistratio Drug An (FDA or the Agency). 2 In this dr aft gu ida nce, the follo wing ter ms are u sed to describe biological products licensed under section 351(k) of the PHS Act: (1 biosimilar or bi) osimilar product refer s to a product that o FDA has determined to be biosimilar t

the reference prod uct (see thsece PHS Act); and (2) tions interch351ang(i)(eab2) le, and 351(k)(2) of interchangeable biosimilar, or interchangeable product refers to a thbiatosi FDA hmi lar as also pr oduct determined to be interchefeangreabence product (seele with351( ti)h(3) e rand sections 351(k)(4) of the PHS Act). Biosimilarity, in terchangesseability, and in m ore d detrelated issuai l in sect es are dion II oiscuf this draft guidance.

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As stated in FDA’Cs onsiguidaderations in nDemonces ftratior ing Interchanndustry geability With a Reference Product (May 2019), FDA expliects thcants seeat appki inng ttercho demangonsteab riatlity will su e bmit data and inform ation to support a sble produchowing thatt can be e the propos xpected ied to produce tnterchangea he same clinical result a product is the refen all of thee prrodencuce t’s licensed referenc conditions of use. We update guidances periodically. F nce,or t chhe meck ost recent the F DA Druversigs guion of adance guidaweb page at https://www.fda.gonfovr/regumatiolatory-in/search-fddocum. enta-gusidance-

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Unless otherwis bie speciosimilar product fi labeleindg a, tnd he tl as abeermling uses d in t his guidance address only the prescribas dinescg informribed in 21 Canatid 20o 1.n FR 201.56 57. 1

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