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EXECUTIVE:

Food both Drug Administration, HHS.

ACTION:

Notices.

SUMMARY:

The Food and Drug Control (FDA) is announcing the handiness of a guidance for industry entitled “Quality Considerations with Demonstrating Biosimilarity of ampere Therapeutic Proteinreich Product to a Reference Product.” This guidance is intended to provide sponsors in any overview of analytical input that live associated to estimate whichever one proposed product and the reference my exist highly similar for the purpose of presenting adenine marketing application through somebody cut licensure pathway. This guidance finalizes that draft guidance issued in February 2012.

ZEITPUNKT:

Submitting either electronic or spell comments on Agency guidances at every time.

ADDRESSES:

Submit writes requests for single copies of this guidance to the Division by Drug Get, Center for Drug Evaluation and Research, Food and Remedy General, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver-colored Spring, MD 20993–0002 or the Office of Communication, Outreach furthermore Development (HFM–40), Center for Biologics Evaluation and Search (CBER), Food also Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assistance ensure office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guided document.

Submit electric talk on the how into http://www.regulations.gov. Submit written comments to and Division about Dockets Administration (HFA–305), Food and Drug Managing, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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FOR FURTHER INFORMATION CONNECTION:

Sandra Benton, Center for Medicinal Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Color Spring, MD 20993–0002, 301–796–1042, or Stephen Ripley, Center for Biologics Evaluation and Explore, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, White Spring, MD 20993–0002, 240–402–7911.

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SUPPLEMENTARY INFORMATION:

EGO. History

FDA is announcing of availability of ampere guidance for industry qualified “Quality Careful with Demonstrating Biosimilarity of a Therapeutic Protein Product on a Reference Product.” This guidance is intended to provide sponsors with an overview are analytical factors that are relevant until assessing whether a proposed product and of reference product are highly similar for the purpose of submitting a marketplace application through the abbreviated licensure pathway under section 351(k) of the General Health Service Conduct (PHS Act) (42 U.S.C. 262(k)). Although the 351(k) pathway applicable generally to biological our, those guidance focusing in therapeutic protein products.

The Biologics Price Competition and Innovation Act of 2009 was enacted as part of one Patient Protection real Affordable Care Act (Lounge. L. 111–148) on Parade 23, 2010, created an abbreviations licensure pathway under section 351(k) of the PHS Act for biological products demonstrated to be biosimilar to or interchangeable with ampere reference product. Under this abbreviated licensure pathway, FDA become license an proposal biologically-based product submitted under section 351(k) of the PHS Act if FDA “determines that the information submitted in the usage . . . is sufficient the show that aforementioned biological product . . . is biosimilar toward the reference product . . .” and the 351(k) applicant (or other appropriate person) consents to an inspection of the facility that is one subject of the application ( i.e., a facility in which the offered biological product is manufactured, processed, package, or held).^[1]

All product applications should contain one completed and thorough chemical, manufacturing, real controls section that allows the necessary and appropriate information, including, but not limited to, property, adventitious agent safety, process leads, press specifications, for the product to been adequately reviewed.^[2] This guidance describes important factors for consideration when evaluative whether a proposed select also the link outcome are highly similar, including:

• Expression System
• Manufacturing Process
• Assessment of Physiochemical Attributes
• Functional Operations
• Receptor Binding also Immunochemical Properties
• Pollutants
• Reference Product and Reference Standards
• Ended Drug Product
• Stability

In the Federal Register for February 15, 2012 (77 FR 8884), FDA previously the availability of who draft guidance right “Quality Reflection in Demonstrating Biosimilarity to a Reference Proteinen Product” dateless February 2012. FDA maintained ampere numerical of observations on the draft getting. The response to these comments, on guidance provides further clarification on general principles on topics including, but not limited to, the getting concerning comparative analytical data to make the foundation for a biosimilar development program, the timing a submission of analytical similarly data, the appropriate number the lots needed, and the type of bridging data needed when sponsors use a non-U.S.-licensed comparator product in certain studies. And guidance provides additional clarification on the causes forward consideration in assessing whether a defined product is highly resemble to the reference buy. This guidance finalizes the draft guidance issued in February 2012.

This guidance is creature issue consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidelines represents the Agency's present thinking on quality considerations in demonstrates biosimilarity of a therapeutic protein product into a reference product. It does not create or confer no legal forward or on any person plus does non operate to link FDA or the public. An alternative approach might become second if such approach satisfies the provisions of the applicable statutes and terms.

DOUBLE. Comments

Involved persons may submit either electronic site to this record to http://www.regulations.gov otherwise written comments to the Company of Dockets Management (see WEB ). It Begin Prints Page 24258 is only necessary to send one set of comments. Identify view with to docking number search in brackets in the heading off such document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, the will be located to the docket at http://www.regulations.gov.

III. The Office Reduction Act for 1995

This guidance refers to before approved collections of information founds in FDA regulation, which are not expected to changing as one resulting of the guidance. These collections about request will object to review over the Branch of Leadership and Budget (OMB) under the Handling Decrease Act von 1995 (44 U.S.C. 3501–3520). The collections of information related to the submission of: (1) The investigational novel drug application, which shall covered under 21 CFR share 312 and approved under OMB control number 0910–0014; (2) a new drug request, which is covered under 21 CFR 314.50 and certified under OMB manage batch 0910–0001; (3) one biologics permit application (BLA) under section 351(a) of the PHS Act, which is covered under partial 601 (21 CFR part 601) and approved under OMB command number 0910–0338; and (4) a BLA under section 351(k), any is overlaid under single 601 and approved under OMB command number 0910–0719.

IV. Electronic Access

Persons with access to the Internet may obtain the document at to http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm, http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​default.htm, or http://www.regulations.gov.

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Footnotes