8880 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 

the special control for the automated 

blood cell separator device operating on 

a filtration separation principle 

intended for the routine collection of 

blood and blood components 

reclassified as class II (§ 864.9245 (21 

CFR 864.9245)). 

For currently marketed products not 

approved under the premarket approval 

process, the manufacturer should file 

with FDA for 3 consecutive years an 

annual report on the anniversary date of 

the device reclassification from class III 

to class II or, on the anniversary date of 

the 510(k) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 360) clearance. Any subsequent 

change to the device requiring the 

submission of a premarket notification 

in accordance with section 510(k) of the 

FD&C Act should be included in the 

annual report. Also, a manufacturer of a 

device determined to be substantially 

equivalent to the centrifugal or 

filtration-based automated cell separator 

device intended for the routine 

collection of blood and blood 

components, should comply with the 

same general and special controls. 

The annual report should include, at 

a minimum, a summary of anticipated 

and unanticipated adverse events that 

have occurred and that are not required 

to be reported by manufacturers under 

Medical Device Reporting (MDR) (part 

803 (21 CFR part 803)). The reporting of 

adverse device events summarized in an 

annual report will alert FDA to trends 

or clusters of events that might be a 

safety issue otherwise unreported under 

the MDR regulation. 

Reclassification of this device from 

class III to class II for the intended use 

of routine collection of blood and blood 

components relieves manufacturers of 

the burden of complying with the 

premarket approval requirements of 

section 515 of the FD&C Act (21 U.S.C. 

360e), and may permit small potential 

competitors to enter the marketplace by 

reducing the burden. Although the 

special control guidance recommends 

that manufacturers of these devices file 

with FDA an annual report for 3 

consecutive years, this would be less 

burdensome than the current 

postapproval requirements under part 

814, subpart E (21 CFR part 814, subpart 

E), including the submission of periodic 

reports under § 814.84. 

Collecting or transfusing facilities, 

and manufacturers have certain 

responsibilities under the Federal 

regulations. For example, collecting or 

transfusing facilities are required to 

maintain records of any reports of 

complaints of adverse reactions (21 CFR 

606.170), while the manufacturer is 

responsible for conducting an 

investigation of each event that is 

reasonably known to the manufacturer 

and evaluating the cause of the event 

(§ 803.50(b)). In addition, manufacturers 

of medical devices are required to 

submit to FDA individual adverse event 

reports of death, serious injury, and 

malfunctions (§ 803.50). 

In the special control guidance 

document, FDA recommends that 

manufacturers include in their three 

annual reports a summary of adverse 

reactions maintained by the collecting 

or transfusing facility or similar reports 

of adverse events collected in addition 

to those required under the MDR 

regulation. The MedWatch medical 

device reporting code instructions 

(http://www.fda.gov/cdrh/mdr/

373.html) contains a comprehensive list 

of adverse events associated with device 

use, including most of those events that 

we recommend summarizing in the 

annual report. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Reporting activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Annual Report ..................................................................................... 4 1 4 5 20 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on FDA records, there are 

approximately four manufactures of 

automated blood cell separator devices. 

We estimate that the manufacturers will 

spend approximately 5 hours preparing 

and submitting the annual report. 

Other burden hours required for 

§ 864.9245 are reported and approved 

under OMB control number 0910–0120 

(premarket notification submission 

501(k), 21 CFR part 807, subpart E), and 

OMB control number 0910–0437 (MDR, 

21 CFR part 803). 

Dated: February 9, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3551 Filed 2–14–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–1029] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; General Licensing 

Provisions; Section 351(k) Biosimilar 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the concerning each 

proposed collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection for the requirements for an 

application for a proposed biosimilar 

product and an application for a 

supplement for a proposed 

interchangeable product. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 16, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane., Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 


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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 8881 

PI50–400B, Rockville, MD 20850, 301– 

796–7651. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

General Licensing Provisions; Section 

351(K) Biosimilar Applications 

On March 23, 2010, the President 

signed into law the Patient Protection 

and Affordable Care Act (Affordable 

Care Act) (Pub. L. 111–148). The 

Affordable Care Act contains a subtitle 

called the Biologics Price Competition 

and Innovation Act of 2009 (BPCI Act) 

which amends the Public Health Service 

Act (PHS Act) and establishes an 

abbreviated licensure pathway for 

biological products shown to be 

biosimilar to, or interchangeable with, 

an FDA-licensed biological reference 

product. (See sections 7001 through 

7003 of the Affordable Care Act.) 

Section 351(k) of the PHS Act (42 

U.S.C. 262(k)), added by the BPCI Act, 

sets forth the requirements for an 

application for a proposed biosimilar 

product and an application for a 

supplement for a proposed 

interchangeable product. Section 351(k) 

defines biosimilarity to mean ‘‘that the 

biological product is highly similar to 

the reference product notwithstanding 

minor differences in clinically inactive 

components’’ and that ‘‘there are no 

clinically meaningful differences 

between the biological product and the 

reference product in terms of the safety, 

purity, and potency of the product’’. 

(See section 351(i)(2) of the PHS Act.) A 

351(k) application must contain, among 

other things, information demonstrating 

that the biological product is biosimilar 

to a reference product based upon data 

derived from analytical studies, animal 

studies, and clinical studies, unless 

FDA determines, in its discretion, that 

certain studies are unnecessary in a 

351(k) application. (See section 

351(k)(2).) To demonstrate 

interchangeability, an applicant must 

provide sufficient information to 

demonstrate biosimilarity, and that the 

biosimilar biological product can be 

expected to produce the same clinical 

result as the reference product in any 

given patient and, if the biosimilar 

biological product is administered more 

than once to an individual, the risk in 

terms of safety or diminished efficacy of 

alternating or switching between the use 

of the biosimilar biological product and 

the reference product is not greater than 

the risk of using the reference product 

without such alternation or switch. (See 

section 351(k)(4) of the PHS Act.) 

Interchangeable products may be 

substituted for the reference product 

without the intervention of the 

prescribing healthcare provider. (See 

section 351(i)(3) of the PHS Act.) This 

Federal Register information collection 

document begins the process of 

requesting public comment and 

obtaining OMB approval for the 

information collection regarding the 

burden on the submission of a 351(k) 

application not otherwise covered by 

existing OMB approvals. 

In estimating the information 

collection burden for 351(k) 

applications, FDA has reviewed the 

collection of information regarding the 

general licensing provisions for 

biologics license applications (BLAs) 

under section 351(a) of the PHS Act to 

OMB (approved under OMB control 

number 0910–0338). For the 

information collection burden for 351(a) 

applications, FDA described § 601.2(a) 

(21 CFR 601.2(a)) as requiring a 

manufacturer of a biological product to 

submit an application on forms 

prescribed for such purpose with 

accompanying data and information 

including certain labeling information 

to FDA for approval to market a product 

in interstate commerce. FDA also added 

in the burden estimate the container and 

package labeling requirements provided 

under §§ 610.60 through 610.65 (21 CFR 

610.60 through 610.65). The estimated 

hours per response for § 601.2, and 

§§ 610.60 through 610.65, were 860 

hours. 

In addition, in submitting a 351(a) 

application, an applicant completes the 

Form FDA 356h ‘‘Application to Market 

a New Drug, Biologic, or an Antibiotic 

Drug for Human Use.’’ The application 

form serves primarily as a checklist for 

firms to gather and submit certain 

information to FDA. The checklist helps 

to ensure that the application is 

complete and contains all the necessary 

information, so that delays due to lack 

of information may be eliminated. The 

form provides key information to FDA 

for efficient handling and distribution to 

the appropriate staff for review. The 

estimated burden hours for biological 

product submissions using FDA Form 

356h are included under the applicable 

requirements approved under OMB 

control number 0910–0338. 

FDA intends for an applicant to 

submit a 351(k) application following 

Form FDA 356h, modifying the 

information submitted to support the 

information required under section 

351(k) of the BPCI Act. To submit an 

application seeking licensure of a 

proposed biosimilar product under 

section 351(k)(2)(A)(i) and (k)(2)(A)(iii), 

FDA believes that the estimated burden 

hours would be approximately the same 

as noted under OMB control number 

0910–0338 for a 351(a) application—860 

hours. The burden estimates for seeking 

licensure of a proposed biosimilar 

product that meets the standards for 

interchangeability under section 

351(k)(2)(B) and (k)(4) would also be 

860 hours. Until we gain more 

experience with biosimilar applications, 

FDA believes this estimate is 

appropriate for 351(k) applications 

because to determine biosimilarity or 

interchangeability of a proposed 351(k) 

product, the application and the 

information submitted is expected to be 

comparably complex and technically 

demanding as a proposed 351(a) 

application. FDA may determine, in its 

discretion, that an element required 

under a 351(k) application to be 

unnecessary to support licensure of a 

biosimilar or interchangeable product. 

In those cases, the number of hours per 

response may be less than the hours 

estimated. 

A summary of the collection of 

information requirements in the 

submission of a 351(k) application as 

described under the BPCI Act follows: 

Section 351(k)(2)(A)(i) requires 

manufactures of 351(k) products to 


sroberts on DSK5SPTVN1PROD with NOTICES
8882 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 

submit an application for FDA review 

and licensure before marketing a 

biosimilar product. An application 

submitted under this section shall 

include information demonstrating that: 

• The biological product is biosimilar 

to a reference product based upon data 

derived from analytical studies, animal 

studies (including toxicity) and a 

clinical study or studies (including 

immunogenicity and pharmacokinetics 

or pharmacodynamics). The Secretary of 

Health and Human Services (the 

Secretary) may determine that any of 

these elements is unnecessary. 

• The biological product and 

reference product utilize the same 

mechanism or mechanisms of action for 

the condition or conditions of use 

prescribed, recommended, or suggested 

in the proposed labeling, but only to the 

extent the mechanism or mechanisms of 

action are known for the reference 

product. 

• The condition or conditions of use 

prescribed, recommended, or suggested 

in the labeling proposed for the 

biological product have been previously 

approved for the reference product. 

• The route of administration, the 

dosage form, and the strength of the 

biological product are the same as those 

of the reference product. 

• The facility in which the biological 

product is manufactured, processed, 

packed, or held meets standards 

designed to assure that the biological 

product continues to be safe, pure, and 

potent. 

Section 351(k)(2)(A)(iii) requires the 

application to include publiclyavailable information regarding the 

Secretary’s previous determination that 

the reference product is safe, pure, and 

potent. The application may include 

any additional information in support of 

the application, including publiclyavailable information with respect to the 

reference product or another biological 

product. 

Under section 351(k)(2)(B) and (k)(4), 

a manufacturer may include information 

demonstrating that the biological 

product meets the standards for 

interchangeability either in the 

application described above to show 

biosimilarity, or in a supplement to 

such an application. The information 

submitted to meet the standard for 

interchangeability must show that: (1) 

The biological product is biosimilar to 

the reference product and can be 

expected to produce the same clinical 

result as the reference product in any 

given patient and (2) for a biological 

product that is administered more than 

once to an individual, the risk in terms 

of safety or diminished efficacy of 

alternating or switching between use of 

the biological product and the reference 

product is not greater than the risk of 

using the reference product without 

such alternation or switch. 

In addition to the collection of 

information regarding the submission of 

a 351(k) application for a proposed 

biosimilar or interchangeable biological 

product, section 351(l) of the BPCI Act 

establishes procedures for identifying 

and resolving patent disputes involving 

applications submitted under section 

351(k) of the PHS Act. The burden 

estimates for the patent provisions 

under section 351(l)(6)(C) of the BPCI 

Act are included in table 1 of this 

document and are based on the 

estimated number of 351(k) biosimilar 

respondents. Based on similar reporting 

requirements, FDA estimates this 

notification will take 2 hours. A 

summary of the collection of 

information requirements under 

351(l)(6)(C) follows: 

Not later than 30 days after a 

complaint from the reference product 

sponsor is served to a 351(k) applicant 

in an action for patent infringement 

described under 351(l)(6), section 

351(l)(6)(C) requires that the 351(k) 

applicant provide the Secretary with 

notice and a copy of such complaint. 

The Secretary shall publish in the 

Federal Register notice any complaint 

received under 351(l)(6)(C)(i). 

FDA has not received any 351(k) 

applications to date. Under table 1 of 

this document, the estimated number of 

respondents submitting 351(k) 

applications is based on the estimated 

annual number of manufacturers that 

would submit the required information 

to FDA and the estimated annual 

number of 351(k) submissions FDA 

would receive. In making this estimate, 

FDA has taken into account, among 

other things, the expiration dates of 

patents that relate to potential reference 

products, and general market interest in 

biological products that could be 

candidates for 351(k) applications. 

On November 2 and 3, 2010, FDA 

held a public hearing and established a 

public docket to obtain input on specific 

issues and challenges associated with 

the implementation of the BPCI Act. 

(See Docket No. FDA–2010–N–0477.) 

Based in part on this input, FDA is 

announcing elsewhere in this issue of 

the Federal Register, the availability of 

three draft guidances describing FDA’s 

current interpretation of certain 

statutory requirements added by the 

BPCI Act as well as quality and 

analytical issues, demonstrating 

biosimilarity, and implementation 

policy issues. These draft guidances are: 

‘‘Biosimilars: Questions and Answers 

Regarding Implementation of the 

Biologics Price Competition and 

Innovation Act of 2009,’’ ‘‘Quality 

Considerations in Demonstrating 

Biosimilarity to a Reference Protein 

Product,’’ and ‘‘Scientific 

Considerations in Demonstrating 

Biosimilarity to a Reference Product.’’ 

The Federal Register documents for 

these guidances reference this Federal 

Register information collection 

document regarding the burden on the 

submission of a 351(k) application not 

otherwise covered by existing OMB 

approvals. In addition, we note that the 

draft guidance on ‘‘Scientific 

Considerations in Demonstrating 

Biosimilarity to a Reference Product’’ 

recommends that labeling for a product 

subject to approval under section 351(k) 

include statements that indicate that: (1) 

The product is approved as biosimilar to 

a reference product for stated 

indication(s) and (2) the product (has or 

has not) been determined to be 

interchangeable with the reference 

product. FDA has determined, under 5 

CFR 1320.3(c)(2)), that these labeling 

recommendations are not ‘‘collections of 

information’’ for the purposes of the 

PRA because the statements will 

comprise solely information that FDA 

will supply to the applicant for the 

purpose of disclosing it to the public, 

i.e. FDA’s determination upon review of 

the application submitted under section 

351(k), that the product is biosimilar 

and/or interchangeable to its reference 

product. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

351(k) Application for biosimilars (42 U.S.C. 262(k)) Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

351(k)(2)(A)(i) and (k)(2)(A)(iii) ............................................ 2 1 2 860 1720 

351(k)(2)(B) and (k)(4) ......................................................... 1 1 1 860 860 


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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 8883 

1 In section 7002(b)(3) of the Patient Protection 

and Affordable Care Act (Affordable Care Act), 

Public Law 111–148, ‘‘biosimilar’’ or 

‘‘biosimilarity’’ means ‘‘that the biological product 

is highly similar to the reference product 

notwithstanding minor differences in clinically 

inactive components,’’ and that ‘‘there are no 

clinically meaningful differences between the 

biological product and the reference product in 

terms of the safety, purity, and potency of the 

product.’’ 

2Section 7002(a)(2) of the Affordable Care Act, 

adding section 351(k)(3) of the PHS Act (citing 

section 351(a)(2)(C) of the PHS Act). 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

351(k) Application for biosimilars (42 U.S.C. 262(k)) Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

351(l)(6)(C) ........................................................................... 2 1 2 2 4 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: February 9, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3548 Filed 2–14–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0605] 

Draft Guidance for Industry on 

Scientific Considerations in 

Demonstrating Biosimilarity to a 

Reference Product; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Scientific 

Considerations in Demonstrating 

Biosimilarity to a Reference Product.’’ 

This draft guidance is intended to assist 

sponsors in demonstrating that a 

proposed therapeutic protein product is 

biosimilar to a reference product for the 

purpose of submitting a marketing 

application through an abbreviated 

licensure pathway. This draft guidance 

gives an overview of FDA’s approach to 

determining biosimilarity. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by April 16, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Sandra Benton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6340, 

Silver Spring, MD 20993–0002, 301– 

796–1042; or Stephen Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

Suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Scientific Considerations in 

Demonstrating Biosimilarity to a 

Reference Product.’’ This draft guidance 

is intended to assist sponsors in 

demonstrating that a proposed 

therapeutic protein product is 

‘‘biosimilar’’ 1 to a reference product for 

the purpose of submitting a marketing 

application through the abbreviated 

licensure pathway under section 351(k) 

of the Public Health Service Act (PHS 

Act) (42 U.S.C. 262(k)). 

The Biologics Price Competition and 

Innovation Act of 2009, enacted as part 

of the Affordable Care Act (Pub. L. 111– 

148) on March 23, 2010, created an 

abbreviated licensure pathway under 

section 351(k) of the PHS Act for 

biological products demonstrated to be 

biosimilar to, or interchangeable with, a 

reference product. Under this 

abbreviated licensure pathway, FDA 

will license a proposed biological 

product submitted under section 351(k) 

of the PHS Act if FDA ‘‘determines that 

the information submitted in the 

application * * * is sufficient to show 

that the biological product is biosimilar 

to the reference product * * *’’ and the 

351(k) applicant (or other appropriate 

person) consents to an inspection of the 

facility that is the subject of the 

application (i.e., a facility in which the 

proposed biological product is 

manufactured, processed, packed, or 

held).2 The draft guidance gives an 

overview of FDA’s approach to 

determining biosimilarity. FDA intends 

to consider the totality of the evidence 

submitted in a 351(k) application and is 

recommending that sponsors use a 

stepwise approach in their development 

of biosimilar products. The draft 

guidance discusses important scientific 

considerations in demonstrating 

biosimilarity, including: 

• A stepwise approach to 

demonstrating biosimilarity, which can 

include a comparison of the proposed 

therapeutic protein product and the 

reference product with respect to 

structure, function, animal toxicity, 

human pharmacokinetics and 

pharmacodynamics, clinical 

immunogenicity, and clinical safety and 

effectiveness; 

• The totality-of-the-evidence 

approach that FDA will use to review 

applications for biosimilar products; 

and 

• General scientific principles in 

conducting comparative structural and 

functional analysis, animal testing, 

human pharmacokinetics and 

pharmacodynamics studies, clinical 

immunogenicity assessment, and 

clinical safety and effectiveness studies 

(including clinical study design issues). 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on scientific considerations in 

demonstrating biosimilarity to a 

reference product. It does not create or 

confer any rights for or on any person 


sroberts on DSK5SPTVN1PROD with NOTICES