I 

110TH CONGRESS 

1ST SESSION H. R. 1956 

To amend the Public Health Service Act to provide for the approval of 

similar biological products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 19, 2007 

Mr. INSLEE (for himself, Mr. GENE GREEN of Texas, and Ms. BALDWIN) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to provide for 

the approval of similar biological products, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Patient Protection and 

5 Innovative Biologic Medicines Act of 2007’’. 

6 SEC. 2. APPROVAL OF SIMILAR BIOLOGICAL PRODUCTS. 

7 (a) IN GENERAL.—Section 351 of the Public Health 

8 Service Act (42 U.S.C. 262) is amended— 


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1 (1) in subsection (j), by striking ‘‘under sub2 section (a)’’ and inserting ‘‘under subsection (a) or 

3 (k)’’; and 

4 (2) by adding at the end the following: 

5 ‘‘(k) SIMILAR BIOLOGICAL PRODUCTS.— 

6 ‘‘(1) APPLICATION.— 

7 ‘‘(A) SUBMISSION.—Any person may sub8 mit an application under this subsection for ap9 proval of a biologics license for a biological 

10 product (in this section referred to as the ‘simi11 lar biological product’) that is claimed to be 

12 similar to a qualified biological product (in this 

13 subsection referred to as the ‘reference prod14 uct’). 

15 ‘‘(B) DEFINITION.—In this subsection, the 

16 term ‘qualified biological product’ means a bio17 logical product that is a biotechnology-derived 

18 therapeutic biological product licensed under 

19 subsection (a) or a biotechnology-derived thera20 peutic protein product subject to an approved 

21 application that was submitted under section 

22 505(b)(1) of the Federal Food, Drug, and Cos23 metic Act. 

24 ‘‘(2) REVIEW AND APPROVAL OF SIMILAR BIO25 LOGICAL PRODUCT APPLICATIONS.— 


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1 ‘‘(A) REVIEW.—An application submitted 

2 under this subsection for a similar biological 

3 product shall be reviewed— 

4 ‘‘(i) by the division that was respon5 sible for review and approval of the ref6 erence product; and 

7 ‘‘(ii) in accordance with the proce8 dures for review of biologics license appli9 cations established by the Secretary pursu10 ant to subsection (a)(2)(A). 

11 ‘‘(B) APPROVAL.—The Secretary shall ap12 prove the application submitted under para13 graph (1) only if— 

14 ‘‘(i) the applicant demonstrates that 

15 the similar biological product conforms to 

16 the applicable final product-class specific 

17 guidance and, on the basis of the data sub18 mitted in conformance with such guidance, 

19 the Secretary concludes the product is 

20 safe, pure, and potent; 

21 ‘‘(ii) the facility in which the similar 

22 biological product is manufactured, proc23 essed, packed, or held meets standards de24 signed to assure that the biological product 

25 continues to be safe, pure, and potent; and 


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1 ‘‘(iii) the applicant (or other appro2 priate person) consents to the inspection of 

3 the facility that is the subject of the appli4 cation, in accordance with subsection (c). 

5 ‘‘(C) CONDITIONS OF APPROVAL.—The 

6 Secretary may approve an application submitted 

7 under paragraph (1) for a similar biological 

8 product— 

9 ‘‘(i) only for indications for which the 

10 reference product is approved; and 

11 ‘‘(ii) only if, with respect to each such 

12 indication, the application conforms to the 

13 applicable final product-class specific guid14 ance, and on the basis of non-clinical and 

15 clinical data submitted regarding such in16 dication, the Secretary concludes the prod17 uct is safe, pure, and potent. 

18 ‘‘(D) THERAPEUTIC EQUIVALENCE.—The 

19 Secretary shall not designate a similar biologi20 cal product as therapeutically equivalent to the 

21 reference product. 

22 ‘‘(3) TIME FRAMES FOR APPLICATION AND AU23 THORIZATION.— 


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1 ‘‘(A) SUBMISSION OF APPLICATIONS.—No 

2 application for a similar biological product may 

3 be submitted under this subsection unless— 

4 ‘‘(i) the Secretary has published under 

5 paragraph (5) final product-class specific 

6 guidance applicable to the reference prod7 uct; and 

8 ‘‘(ii) not less than 12 years have 

9 elapsed from the date on which the ref10 erence product was approved or licensed. 

11 ‘‘(B) EFFECTIVE DATE OF APPROVAL.— 

12 Subject to subparagraph (C), approval of an 

13 application submitted under paragraph (1) shall 

14 not be made effective until at least 14 years 

15 have elapsed from the date on which the ref16 erence product was approved or licensed. 

17 ‘‘(C) SIGNIFICANT CLINICAL BENEFIT.— 

18 Approval of an application submitted under 

19 paragraph (1) shall not be made effective until 

20 at least 15 years have elapsed from the date on 

21 which the reference product was approved or li22 censed if— 

23 ‘‘(i) during the 12-year period fol24 lowing the approval or licensing of the ref25 erence product, the Secretary approves a 


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1 supplement to the new drug or biologics li2 cense application for the reference product 

3 that seeks approval to market the ref4 erence product for a new indication; and 

5 ‘‘(ii) in the opinion of the Secretary, 

6 the new indication provides a significant 

7 clinical benefit in comparison with existing 

8 therapies. 

9 ‘‘(D) EXCLUSIVE APPROVAL PATHWAY.— 

10 The Secretary may not approve, under any 

11 other provision of law, a product that is claimed 

12 to be similar to or the same as a reference 

13 product. 

14 ‘‘(4) REQUESTS FOR ISSUANCE OF PRODUCT15 CLASS SPECIFIC GUIDANCE.— 

16 ‘‘(A) IN GENERAL.—Any person may sub17 mit a request to the Secretary for the issuance 

18 of product-class specific guidance applicable to 

19 a qualified biological product and its class. 

20 ‘‘(B) PRIORITY.—The Secretary— 

21 ‘‘(i) in prioritizing among requests 

22 under this paragraph for guidance, shall 

23 consider likely market entry dates of simi24 lar biological products and the amount of 

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1 quested product-class specific guidance; 

2 and 

3 ‘‘(ii) may summarily reject frivolous 

4 or unsupported requests. 

5 ‘‘(C) ISSUANCE OF GUIDANCE.—In re6 sponse to a request under this paragraph, the 

7 Secretary shall— 

8 ‘‘(i) publish in the Federal Register a 

9 concept paper setting forth the specific 

10 questions to be addressed in product-class 

11 specific guidance and invite comments on 

12 the concept paper from any interested per13 sons; 

14 ‘‘(ii) accept comments on the concept 

15 paper for not less than 4 months; 

16 ‘‘(iii) consider the public comments on 

17 the concept paper; 

18 ‘‘(iv) publish in the Federal Register 

19 proposed product-class specific guidance 

20 and invite comments on the proposed guid21 ance from any interested persons; 

22 ‘‘(v) accept comments on the proposed 

23 guidance for not less than 6 months; 


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1 ‘‘(vi) obtain the advice of the Similar 

2 Biological Products Advisory Committee 

3 with respect to the proposed guidance; and 

4 ‘‘(vii) except as provided in subpara5 graph (D), not later than 24 months after 

6 receipt of the initial request, publish in the 

7 Federal Register final product-class spe8 cific guidance or a determination that, 

9 given the current state of scientific and 

10 technical knowledge, it is not possible to 

11 issue product-class specific guidance set12 ting forth data that will ensure the safety, 

13 purity, and potency of similar biological 

14 products to be covered by the guidance. 

15 ‘‘(D) CONSOLIDATION OF REQUESTS.—The 

16 Secretary may consolidate requests submitted 

17 under this paragraph that refer to closely re18 lated products or product classes. If the Sec19 retary chooses to consolidate such requests, the 

20 Secretary shall publish final product-class spe21 cific guidance or a determination described in 

22 subparagraph (C)(vii) not later than 30 months 

23 after receipt of the first request for guidance 

24 for any product in the class. 

25 ‘‘(5) PRODUCT-CLASS SPECIFIC GUIDANCE.— 


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1 ‘‘(A) IN GENERAL.—Guidance published 

2 under paragraph (4) shall describe the data and 

3 information that will be required in an applica4 tion submitted under paragraph (1). 

5 ‘‘(B) REQUIRED ELEMENTS.—At a min6 imum, guidance published under paragraph (4) 

7 shall require— 

8 ‘‘(i) data demonstrating the consist9 ency and robustness of the manufacturing 

10 process for an active ingredient of the 

11 similar biological product and the finished 

12 formulation of the similar biological prod13 uct; 

14 ‘‘(ii) data demonstrating the stability, 

15 compatibility (such as with excipients), and 

16 biological and physicochemical integrity of 

17 the active ingredient of the similar biologi18 cal product; 

19 ‘‘(iii) data from physical, chemical, 

20 and biological assays fully characterizing 

21 the similar biological product, in compari22 son with the reference product, at both the 

23 active ingredient and finished product lev24 els; 


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1 ‘‘(iv) data from comparative nonclin2 ical studies demonstrating that the similar 

3 biological product and the reference prod4 uct have similar profiles in terms of phar5 macokinetics, pharmacodynamics, toxicity, 

6 immunogenicity, and other relevant fac7 tors; 

8 ‘‘(v) data from comparative clinical 

9 trials demonstrating that the similar bio10 logical product and the reference product 

11 have similar profiles in terms of safety, pu12 rity, and potency, including pharmaco13 kinetic studies, pharmacodynamic studies, 

14 and trials of sufficient size and duration to 

15 demonstrate that the products are similar 

16 in their safety (in terms of nature, serious17 ness, and frequency of adverse reactions), 

18 purity, and potency profiles; and 

19 ‘‘(vi) a plan for postmarketing safety 

20 monitoring (in addition to ordinary 

21 pharmacovigilance), including with respect 

22 to clinical trials; antibody testing and, as 

23 appropriate, other tests to investigate 

24 immunogenicity; patient registries; and 

25 other surveillance measures to monitor the 


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1 clinical safety and risk-benefit balance of 

2 the similar biological product. 

3 ‘‘(6) REVISIONS TO GUIDANCE.—If a new con4 dition of use is approved for a reference product 

5 after the latest publication of the final product-class 

6 specific guidance applicable to such product, the 

7 Secretary shall promptly update and republish the 

8 guidance in accordance with paragraphs (4) and (5) 

9 (irrespective of whether a request for such revision 

10 has been received under paragraph (4)(A)) to ad11 dress the data and information that will be required 

12 in an application under this subsection for approval 

13 of the new condition of use. The requirements of 

14 paragraph (2)(C) shall apply if the new condition of 

15 use is a new indication. 

16 ‘‘(7) SIMILAR BIOLOGICAL PRODUCTS ADVISORY

17 COMMITTEE.— 

18 ‘‘(A) ESTABLISHMENT.—The Secretary 

19 shall establish a Similar Biological Products 

20 Advisory Committee (in this paragraph referred 

21 to as the ‘Committee’). 

22 ‘‘(B) DUTIES.—The Committee shall— 

23 ‘‘(i) provide expert scientific advice 

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1 garding the development and approval of 

2 similar biological products; and 

3 ‘‘(ii) in formulating such advice and 

4 recommendations, provide interested per5 sons with a reasonable opportunity to 

6 make written and oral presentations. 

7 ‘‘(C) MEMBERSHIP.— 

8 ‘‘(i) QUALIFICATIONS.—The Secretary 

9 shall appoint to serve on the Committee in10 dividuals with expertise on therapeutic bio11 logical products, including manufacturing, 

12 safety, effectiveness, and other relevant 

13 matters. The Secretary shall ensure that 

14 the Committee consists of members with 

15 adequately diversified expertise and prac16 tical experience in such fields as clinical 

17 medicine, biological and physical sciences, 

18 pharmacoepidemiology and postmarket 

19 safety surveillance, and related professions. 

20 ‘‘(ii) NOMINATIONS.—In appointing 

21 members of the Committee, the Secretary 

22 shall provide an opportunity for scientific, 

23 industry, and consumer organizations and 

24 the public to nominate such members. 


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1 ‘‘(iii) NONVOTING MEMBERS.—The 

2 Committee shall include, as nonvoting 

3 members, representatives of patient organi4 zations, manufacturers of innovative bio5 logical products, and manufacturers of 

6 similar biological products. 

7 ‘‘(iv) SUPPLEMENTAL MEMBER8 SHIP.—For the purpose of developing 

9 product-class specific guidance under para10 graphs (4) and (5), the Secretary may sup11 plement the membership of the Committee, 

12 or arrange for advice from another advi13 sory committee, in order to obtain the ad14 vice of individuals with special expertise re15 lating to any product under review. 

16 ‘‘(l) PROPER NAME.—For purposes of this section: 

17 ‘‘(1) BIOTECHNOLOGY-DERIVED THERAPEUTIC

18 PROTEINS.— 

19 ‘‘(A) IN GENERAL.—Subject to subpara20 graph (D), the term ‘proper name’, with respect 

21 to a biotechnology-derived therapeutic protein, 

22 means— 

23 ‘‘(i) the name adopted for such pro24 tein by the United States Adopted Names 


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1 Council if such name is a unique USAN; 

2 or 

3 ‘‘(ii) if the biotechnology-derived 

4 therapeutic protein lacks a unique USAN, 

5 an official name designated pursuant to 

6 subparagraph (C). 

7 ‘‘(B) UNIQUE USAN.—The term ‘unique 

8 USAN’, with respect to a biotechnology-derived 

9 therapeutic protein, means a name adopted for 

10 such protein by the United States Adopted 

11 Names Council that has not been adopted for 

12 any protein manufactured by a different person. 

13 ‘‘(C) DESIGNATION.—The Secretary shall 

14 designate an official name for any bio15 technology-derived therapeutic protein that 

16 lacks a unique USAN. Any official name des17 ignated under this subparagraph shall be the 

18 only official name of that protein used in any 

19 official compendium published after such name 

20 has been designated. In no event, however, shall 

21 the Secretary designate an official name so as 

22 to infringe a valid trademark. Any designation 

23 under this subparagraph shall be made by rule 

24 in accordance with section 553 of title 5, 

25 United States Code. 


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1 ‘‘(D) EXCEPTION.—The term ‘proper 

2 name’, with respect to a biotechnology-derived 

3 therapeutic protein that was licensed by the 

4 Secretary prior to the effective date of the Pa5 tient Protection and Innovative Biologic Medi6 cines Act of 2007, means the name adopted for 

7 such protein by the United States Adopted 

8 Names Council, irrespective of whether such 

9 name is a unique USAN. 

10 ‘‘(2) OTHER BIOLOGICAL PRODUCTS.—The 

11 term ‘proper name’, with respect to a biological 

12 product that is not a biotechnology-derived thera13 peutic protein, means— 

14 ‘‘(A) the official name designated by the 

15 Secretary for such biological product pursuant 

16 to section 508 of the Federal Food, Drug, and 

17 Cosmetic Act; 

18 ‘‘(B) if there is no such official name and 

19 such biological product is an article recognized 

20 in an official compendium, the official title 

21 thereof in such compendium; or 

22 ‘‘(C) if neither subparagraph (A) nor sub23 paragraph (B) applies, the common or usual 

24 name, if any, of such biological product.’’. 


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1 (b) CONFIDENTIALITY.—Subsection (j) of section 

2 351 of the Public Health Service Act (42 U.S.C. 262), 

3 as amended by subsection (a)(1), is further amended by 

4 adding at the end the following: ‘‘The Secretary shall 

5 maintain the confidentiality of information submitted 

6 under this section for a biological product to the same ex7 tent and in the same manner as the Secretary maintains 

8 the confidentiality of information submitted under section 

9 505 of the Federal Food, Drug, and Cosmetic Act for a 

10 drug.’’. 

11 SEC. 3. AMENDMENTS TO FEDERAL FOOD, DRUG, AND COS12 METIC ACT. 

13 (a) LABELING.—Section 502 of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 352) is amended by 

15 adding at the end the following: 

16 ‘‘(y) If it is a biotechnology-derived therapeutic pro17 tein, it was licensed under section 351 of the Public 

18 Health Service Act prior to the effective date of the Pa19 tient Protection and Innovative Biologic Medicines Act of 

20 2007, it lacks a unique USAN, and its labeling fails to 

21 bear (i) its proper name (as defined in section 351(l) of 

22 the Public Health Service Act); (ii) its brand name or 

23 phrasing, approved by the Secretary, that adequately dis24 tinguishes it from other approved biotechnology-derived 

25 therapeutic proteins with the same proper name; and (iii) 


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1 the following warning: ‘Any change in øinsert the proper 

2 name of the product¿, including a change in manufac3 turer, should be made cautiously and only if authorized 

4 by and supervised by the prescribing health care profes5 sional.’. The requirement in the preceding sentence re6 garding the inclusion of a warning applies beginning on 

7 the date that is 180 days after the date of the enactment 

8 of the Patient Protection and Innovative Biologic Medi9 cines Act of 2007. 

10 ‘‘(z) If it is a biotechnology-derived therapeutic pro11 tein not subject to paragraph (y), and its labeling fails 

12 to include (i) its proper name (as defined in section 351(l) 

13 of the Public Health Service Act); and (ii) the following 

14 warning: ‘This product shall not be dispensed in substi15 tution for another biological product that was prescribed 

16 to be dispensed, unless such substitution was expressly au17 thorized by and is supervised by the prescribing health 

18 care professional.’. In the case of such a protein that is 

19 a similar biological product licensed under section 351(k) 

20 of the Public Health Service Act, the warning required by 

21 the preceding sentence shall read as follows: ‘This product 

22 shall not be dispensed in substitution for another biologi23 cal product that was prescribed to be dispensed including 

24 øinsert the proprietary name and proper name of the ref25 erence product¿.’ ’’. 


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1 (b) DISPENSING.—Section 503(b) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) is 

3 amended by adding at the end the following: 

4 ‘‘(6) A drug that is subject to paragraph (1) and is 

5 a biotechnology-derived therapeutic protein licensed under 

6 section 351 of the Public Health Service Act shall not be 

7 dispensed unless the prescription specifies the drug’s pro8 prietary name or, if the drug lacks a proprietary name, 

9 the drug’s proper name (as defined in section 351(l) of 

10 such Act). The act of dispensing a drug contrary to the 

11 preceding sentence shall be deemed to be an act which re12 sults in the drug being misbranded while held for sale.’’. 

13 SEC. 4. REPORTS TO CONGRESS. 

14 (a) EXTENSION OF APPROVAL PATHWAY TO OTHER

15 PRODUCTS.—Not later than 2 years after the date of the 

16 enactment of this Act, and every 2 years thereafter, the 

17 Secretary of Health and Human Services shall submit a 

18 report to the Congress making recommendations on 

19 whether it is feasible, in the current state of scientific and 

20 technical knowledge, to approve applications under sub21 section 351(k) of the Public Health Service Act, as added 

22 by section 2 of this Act, for biological products that are 

23 claimed to be similar to vaccines, blood or plasma products 

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1 ucts that do not contain biotechnology-derived therapeutic 

2 proteins as their active ingredients. 

3 (b) THERAPEUTIC EQUIVALENCE DETERMINA4 TIONS.—Not later than 2 years after the date of the enact5 ment of this Act, and every 2 years thereafter, the Sec6 retary of Health and Human Services shall submit a re7 port to the Congress making recommendations on— 

8 (1) whether it is feasible, in the current state 

9 of scientific and technical knowledge, to make thera10 peutic equivalence determinations for similar biologi11 cal products approved under section 351(k) of the 

12 Public Health Service Act, as added by section 2 of 

13 this Act; and 

14 (2) if so, the statutory criteria that should gov15 ern such determinations. 

Æ 


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