II 

110TH CONGRESS 

1ST SESSION S. 1505 

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

biosimilars, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 24, 2007 

Mr. GREGG (for himself, Mr. BURR, and Mr. COBURN) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

To amend the Public Health Service Act to provide for 

the approval of biosimilars, 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 ‘‘Affordable Biologics 

5 for Consumers Act’’. 

6 SEC. 2. APPROVAL OF BIOSIMILARS. 

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) BIOSIMILARS.— 

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 biosimilar. 

10 ‘‘(B) DEFINITIONS.—In this subsection: 

11 ‘‘(i) BIOSIMILAR.—The term ‘bio12 similar’ means a biological product that, in 

13 an application submitted under this sub14 section, is claimed to be similar to a quali15 fied biological product (in this subsection 

16 referred to as the ‘reference product’). 

17 ‘‘(ii) QUALIFIED BIOLOGICAL PROD18 UCT.—The term ‘qualified biological prod19 uct’ means a biological product that is a 

20 biotechnology-derived therapeutic biological 

21 product licensed under subsection (a) or a 

22 biotechnology-derived therapeutic protein 

23 product subject to an approved application 

24 that was submitted under section 


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1 505(b)(1) of the Federal Food, Drug, and 

2 Cosmetic Act. 

3 ‘‘(2) REVIEW AND APPROVAL OF BIOSIMILAR

4 APPLICATIONS.— 

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

6 under this subsection for a biosimilar shall be 

7 reviewed— 

8 ‘‘(i) by the division that was respon9 sible for review and approval of the ref10 erence product; and 

11 ‘‘(ii) in accordance with the proce12 dures for review of biologics license appli13 cations established by the Secretary pursu14 ant to subsection (a)(2)(A). 

15 ‘‘(B) APPROVAL.—The Secretary shall ap16 prove the application submitted under para17 graph (1) only if— 

18 ‘‘(i) the applicant demonstrates that 

19 the biosimilar conforms to the applicable 

20 final product class-specific rule and, on the 

21 basis of the data submitted in conformance 

22 with such rule, the Secretary concludes the 

23 product is safe, pure, and potent; 

24 ‘‘(ii) the applicant demonstrates that 

25 the biosimilar is as similar to the reference 


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1 product as may be achieved given the state 

2 of scientific knowledge and technology ca3 pabilities at the time of submission of the 

4 application; 

5 ‘‘(iii) the applicant demonstrates that 

6 the biosimilar has the same route of ad7 ministration, dosage form, mechanism of 

8 action, and strength as the reference prod9 uct; 

10 ‘‘(iv) the facility in which the bio11 similar is manufactured, processed, 

12 packed, or held meets standards designed 

13 to assure that the biological product con14 tinues to be safe, pure, and potent; and 

15 ‘‘(v) the applicant (or other appro16 priate person) consents to the inspection of 

17 the facility that is the subject of the appli18 cation, in accordance with subsection (c). 

19 ‘‘(C) CONDITIONS OF APPROVAL.—The 

20 Secretary may approve an application submitted 

21 under paragraph (1) for a biosimilar— 

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

23 reference product is approved; 

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

25 indication, the application conforms to the 


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1 applicable final product class-specific rule, 

2 and on the basis of non-clinical and clinical 

3 data submitted regarding such indication, 

4 the Secretary concludes the product is 

5 safe, pure, and potent; and 

6 ‘‘(iii) only if the applicant agrees to 

7 provide to the Secretary, on an ongoing 

8 basis, all written documents it prepares for 

9 any purpose (including any patent litiga10 tion) that characterizes the difference be11 tween the biosimilar and the reference 

12 product. 

13 ‘‘(3) REQUESTS FOR ISSUANCE OF PRODUCT

14 CLASS-SPECIFIC RULE.— 

15 ‘‘(A) IN GENERAL.—Any person may sub16 mit a request to the Secretary for the issuance 

17 of a product class-specific rule applicable to a 

18 qualified biological product and its class. 

19 ‘‘(B) PRIORITY.—The Secretary— 

20 ‘‘(i) in prioritizing among requests 

21 under this paragraph for a rule, shall con22 sider likely market entry dates of 

23 biosimilars and the amount of time that 

24 will be needed to prepare the requested 

25 product class-specific rule; and 


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1 ‘‘(ii) may summarily reject frivolous 

2 or unsupported requests. 

3 ‘‘(C) ISSUANCE OF RULE.— 

4 ‘‘(i) IN GENERAL.—In response to a 

5 request under this paragraph, the Sec6 retary shall carry out notice and comment 

7 rulemaking procedures in accordance with 

8 clause (ii). 

9 ‘‘(ii) PROCEDURES.—To publish prod10 uct class-specific rules under this para11 graph, the Secretary shall, in response to 

12 a request under this paragraph— 

13 ‘‘(I) publish in the Federal Reg14 ister a concept paper setting forth the 

15 specific questions to be addressed in 

16 the product class-specific rule and in17 vite comments on the concept paper 

18 from any interested persons; 

19 ‘‘(II) accept comments on the 

20 concept paper for not less than 4 

21 months; 

22 ‘‘(III) consider the public com23 ments on the concept paper; 

24 ‘‘(IV) publish in the Federal Reg25 ister the proposed product class-speVerDate Aug 31 2005 20:54 May 27, 2007 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1505.IS S1505

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1 cific rule and invite comments on the 

2 proposed rule from any interested per3 sons; 

4 ‘‘(V) accept comments on the 

5 proposed rule for not less than 6 

6 months; 

7 ‘‘(VI) obtain the advice of the 

8 Biosimilars Advisory Committee with 

9 respect to the proposed rule; and 

10 ‘‘(VII) except as provided in sub11 paragraph (D), not later than 2 years 

12 after receipt of the initial request, 

13 publish in the Federal Register the 

14 final product class-specific rule or a 

15 determination that, given the current 

16 state of scientific and technical knowl17 edge, it is not feasible to issue a prod18 uct class-specific rule setting forth 

19 data that will ensure the safety, pu20 rity, and potency of biosimilars to be 

21 covered by the rule. 

22 ‘‘(iii) REPORT TO CONGRESS.—If the 

23 Secretary determines under clause (ii)(VII) 

24 that it is not feasible to issue the final 

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1 lowing the date of the applicable initial re2 quest, the Secretary shall submit to Con3 gress a report that describes why Secretary 

4 was unable to issue such final rule and the 

5 plan and timeline of the Secretary for 

6 issuing such final rule. 

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

8 Secretary may consolidate requests submitted 

9 under this paragraph that refer to closely re10 lated products or product classes. If the Sec11 retary chooses to consolidate such requests, the 

12 Secretary shall publish the final product class13 specific rule or a determination described in 

14 subparagraph (C)(ii)(VII) not later than 30 

15 months after receipt of the first request for a 

16 rule for any product in the class. 

17 ‘‘(4) PRODUCT CLASS-SPECIFIC RULES.— 

18 ‘‘(A) IN GENERAL.—A rule published 

19 under paragraph (3) shall describe the data and 

20 information that will be required in an applica21 tion submitted under paragraph (1). 

22 ‘‘(B) REQUIRED ELEMENTS.—At a min23 imum, a rule published under paragraph (3) 

24 shall require— 


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1 ‘‘(i) data demonstrating the consist2 ency and robustness of the manufacturing 

3 process for the active ingredient or active 

4 ingredients of the biosimilar and the fin5 ished formulation of the biosimilar; 

6 ‘‘(ii) data demonstrating the stability, 

7 compatibility (such as with excipients), and 

8 biological and physicochemical integrity of 

9 the active ingredient or active ingredients 

10 of the biosimilar; 

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

12 and biological assays fully characterizing 

13 the biosimilar, in comparison with the ref14 erence product, at both the active ingre15 dient or active ingredients and finished 

16 product levels; 

17 ‘‘(iv) data from comparative nonclin18 ical studies demonstrating that the bio19 similar and the reference product have 

20 similar profiles in terms of pharmaco21 kinetics, pharmacodynamics, toxicity, 

22 immunogenicity, and other relevant fac23 tors; 

24 ‘‘(v) data from comparative clinical 

25 trials demonstrating that the biosimilar 


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1 and the reference product have similar pro2 files in terms of safety, purity, and po3 tency, including pharmacokinetic studies, 

4 pharmacodynamic studies, immunogenicity 

5 studies, and trials of sufficient size and du6 ration to demonstrate that the products 

7 are similar in their safety (in terms of na8 ture, seriousness, and frequency of adverse 

9 reactions), purity, and potency profiles; 

10 and 

11 ‘‘(vi) data regarding postmarket as12 sessment and monitoring of safety, purity, 

13 and potency, including, as appropriate, 

14 clinical trials, tests to investigate 

15 immunogenicity, patient registries, and 

16 other surveillance measures. 

17 ‘‘(5) REVISIONS TO RULES.—If a new condition 

18 of use is approved for a reference product after the 

19 latest publication of the final product class-specific 

20 rule applicable to such product, the Secretary shall 

21 promptly update and republish the rule in accord22 ance with paragraphs (3) and (4) (irrespective of 

23 whether a request for such revision has been re24 ceived under paragraph (3)(A)) to address the data 

25 and information that will be required in an applicaVerDate Aug 31 2005 20:54 May 27, 2007 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1505.IS S1505

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1 tion under this subsection for approval of the new 

2 condition of use. The requirements of paragraph 

3 (2)(C) shall apply if the new condition of use is a 

4 new indication. 

5 ‘‘(6) BIOSIMILARS ADVISORY COMMITTEE.— 

6 ‘‘(A) ESTABLISHMENT.—The Secretary 

7 shall establish a Biosimilars Advisory Com8 mittee (in this paragraph referred to as the 

9 ‘Committee’). 

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

11 ‘‘(i) provide expert scientific advice 

12 and recommendations to the Secretary re13 garding the development and approval of 

14 biosimilars; and 

15 ‘‘(ii) in formulating such advice and 

16 recommendations, provide interested per17 sons with a reasonable opportunity to 

18 make written and oral presentations. 

19 ‘‘(C) MEMBERSHIP.— 

20 ‘‘(i) QUALIFICATIONS.—The Secretary 

21 shall appoint to serve on the Committee in22 dividuals with expertise on therapeutic bio23 logical products, including manufacturing, 

24 safety, effectiveness, and other relevant 

25 matters. The Secretary shall ensure that 


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1 the Committee consists of members with 

2 adequately diversified expertise and prac3 tical experience in such fields as clinical 

4 medicine, biological and physical sciences, 

5 pharmacoepidemiology and postmarket 

6 safety surveillance, and related professions. 

7 ‘‘(ii) NOMINATIONS.—In appointing 

8 members of the Committee, the Secretary 

9 shall provide an opportunity for scientific, 

10 industry, and consumer organizations and 

11 the public to nominate such members. 

12 ‘‘(iii) NONVOTING MEMBERS.—The 

13 Committee shall include, as nonvoting 

14 members, representatives of patient organi15 zations, manufacturers of innovative bio16 logical products, and manufacturers of 

17 biosimilars. 

18 ‘‘(iv) SUPPLEMENTAL MEMBER19 SHIP.—For the purpose of developing a 

20 product class-specific rule under para21 graphs (3) and (4), the Secretary may sup22 plement the membership of the Committee, 

23 or arrange for advice from another advi24 sory committee, in order to obtain the adVerDate Aug 31 2005 20:54 May 27, 2007 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1505.IS S1505

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1 vice of individuals with special expertise re2 lating to any product under review. 

3 ‘‘(7) TIME FRAMES FOR APPLICATION AND AU4 THORIZATION.— 

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

6 application for a biosimilar may be submitted 

7 under this subsection unless— 

8 ‘‘(i) the Secretary has published under 

9 paragraph (3) a final product class-specific 

10 rule applicable to the reference product; 

11 and 

12 ‘‘(ii) not less than 12 years have 

13 elapsed from the date on which the ref14 erence product was approved or licensed. 

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

16 Subject to subparagraph (C), approval of an 

17 application submitted under paragraph (1) shall 

18 not be made effective until at least 14 years 

19 have elapsed from the date on which the ref20 erence product was approved or licensed. 

21 ‘‘(C) SIGNIFICANT CLINICAL BENEFIT.— 

22 Approval of an application submitted under 

23 paragraph (1) shall not be made effective until 

24 at least 16 years have elapsed from the date on 


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1 which the reference product was approved or li2 censed if— 

3 ‘‘(i) during the 12-year period fol4 lowing the approval or licensing of the ref5 erence product, the Secretary approves a 

6 supplement to the new drug or biologics li7 cense application for the reference product 

8 that seeks approval to market the ref9 erence product for a new indication; and 

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

11 the new indication provides a significant 

12 clinical benefit. 

13 ‘‘(D) SUPPLEMENT APPLICATION OF REF14 ERENCE PRODUCT.—If, at any time following 

15 approval of the reference product, the holder of 

16 the approved reference product application sub17 mits a supplemental application with new clin18 ical data (other than bioavailability data) to 

19 support a new condition of use (other than a 

20 new indication with a significant clinical benefit 

21 approved during the first 12 years after initial 

22 product approval), and those data are essential 

23 to approval of the supplemental application, the 

24 Secretary may not approve an application for a 


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1 biosimilar for the new condition of use for 3 

2 years following approval of the supplement. 

3 ‘‘(E) EXCLUSIVE APPROVAL PATHWAY.— 

4 The Secretary may not approve, under any 

5 other provision of law, a product that is claimed 

6 to be similar to or the same as a reference 

7 product. 

8 ‘‘(F) APPROVAL OF BIOSIMILAR APPLICA9 TION WITH RESPECT TO OLDER REFERENCE

10 PRODUCTS.—Notwithstanding any other provi11 sion of this subsection, an application submitted 

12 under paragraph (1) that relies on a reference 

13 product approved more than 14 years before 

14 the date of enactment of this subsection may be 

15 made effective on the date that is the later of— 

16 ‘‘(i) the publication of a product class17 specific rule under paragraph (3) in which 

18 the reference product is included; or 

19 ‘‘(ii) 1 year after the date of enact20 ment of this subsection. 

21 ‘‘(G) TRANSITION.—If, during the period 

22 following the approval of a reference product 

23 that was approved more than 14 years before 

24 the date of enactment of this subsection but be25 fore the publication of a product class-specific 


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1 rule under paragraph (3) in which the reference 

2 product is included, the holder of the approved 

3 reference product application obtains approval 

4 of a new indication with a significant clinical 

5 benefit as determined by the Secretary, ap6 proval of an application submitted under para7 graph (1) that relies on such reference product 

8 may not be made effective under 16 years after 

9 the date of approval of the reference product. 

10 ‘‘(8) PATENT NOTIFICATIONS AND LINKAGES.— 

11 ‘‘(A) NOTIFICATION.—When an application 

12 for a biosimilar is submitted, the Secretary 

13 shall publish a notice in the Federal Register 

14 identifying— 

15 ‘‘(i) the sponsor of the application of 

16 the reference product upon which the ap17 plication for the biosimilar relies; and 

18 ‘‘(ii) the name of the sponsor of the 

19 application for the biosimilar, or an agent 

20 designated by such sponsor to receive com21 munications regarding patents. 

22 ‘‘(B) INFORMATION FROM PATENT HOLD23 ER.— 

24 ‘‘(i) IN GENERAL.—A patent owner 

25 may— 


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1 ‘‘(I) request information from the 

2 person that submits an application for 

3 a biosimilar under paragraph (1) to 

4 ascertain whether such person’s prod5 uct or processes would infringe on a 

6 patent of the patent owner; 

7 ‘‘(II) provide such person or its 

8 designee a notice of patents that may 

9 be infringed by the production or sale 

10 of the biosimilar, such as patents on 

11 compound (protein sequence), com12 position, host cell, nucleic acid, proc13 ess of production, and method of 

14 treatment patents; or 

15 ‘‘(III) indicate with such notifica16 tion whether the patent holder is open 

17 to licensing the patent rights on a 

18 non-exclusive basis. 

19 ‘‘(ii) NO DECLARATORY JUDGMENT.— 

20 A patent designated as available for licen21 sure pursuant to clause (i)(III) may not be 

22 the subject of a declaratory judgment ac23 tion brought by the biosimilar applicant 

24 prior to approval of the application for a 

25 biosimilar under this subsection. 


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1 ‘‘(C) WRITTEN EXPLANATION.— 

2 ‘‘(i) IN GENERAL.—A person that 

3 submits an application for approval of a 

4 biosimilar under this subsection that re5 quests approval prior to the expiration of 

6 a patent identified by a patent owner shall 

7 provide to such patent owner, a written ex8 planation of— 

9 ‘‘(I) why the patent identified in 

10 subparagraph (B)(i) would not be in11 fringed by the approval of the applica12 tion for the biosimilar; or 

13 ‘‘(II) why the identified patent is 

14 invalid. 

15 ‘‘(ii) COMPLIANCE.—With respect to 

16 process of manufacture patents, the bio17 similar applicant must comply with the re18 quirements of section 295 of title 35, 

19 United States Code. 

20 ‘‘(D) APPROVAL DATE.—Approval of an 

21 application for a biosimilar submitted under 

22 this subsection may be effective on the applica23 ble date described in paragraph (7) even if pat24 ent litigation has not concluded. If a patent is 

25 found valid and infringed before approval of the 


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1 application for a biosimilar, and the patent ex2 pires after the applicable effective date of the 

3 biosimilar application described in paragraph 

4 (7), approval of the biosimilar application may 

5 not be effective until the expiration of the in6 fringed patent. 

7 ‘‘(E) DECLARATORY JUDGMENT ACTION.— 

8 A person that submits an application for a bio9 similar under this subsection may not com10 mence a declaratory judgment action con11 cerning a patent identified in subparagraph 

12 (B)(i) later than 18 months before the applica13 ble effective date of the biosimilar application 

14 described in paragraph (7), or the date that is 

15 60 days after providing the written explanation 

16 in subparagraph (C) of this paragraph, if such 

17 provision occurs during the 18-month period be18 fore the applicable effective date of the bio19 similar application described in paragraph (7). 

20 ‘‘(9) EXCLUSIVITY OF BIOSIMILARS.—The Sec21 retary may not approve an application for a bio22 similar that relies on a reference product for 1 year 

23 after the date of approval of the first biosimilar ap24 plication that relies on such reference product. 

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


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1 ‘‘(1) BIOTECHNOLOGY-DERIVED THERAPEUTIC

2 PROTEINS.— 

3 ‘‘(A) IN GENERAL.—Subject to subpara4 graph (D), the term ‘proper name’, with respect 

5 to a biotechnology-derived therapeutic protein, 

6 means— 

7 ‘‘(i) the name adopted for such pro8 tein by the United States Adopted Names 

9 Council if such name is a unique USAN; 

10 or 

11 ‘‘(ii) if the biotechnology-derived 

12 therapeutic protein lacks a unique USAN, 

13 an official name designated pursuant to 

14 subparagraph (C). 

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

16 USAN’, with respect to a biotechnology-derived 

17 therapeutic protein, means a name adopted for 

18 such protein by the United States Adopted 

19 Names Council that has not been adopted for 

20 any protein manufactured by a different person. 

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

22 designate an official name for any bio23 technology-derived therapeutic protein that 

24 lacks a unique USAN. Any official name des25 ignated under this subparagraph shall be the 


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1 only official name of that protein used in any 

2 official compendium published after such name 

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

4 the Secretary designate an official name so as 

5 to infringe a valid trademark. Any designation 

6 under this subparagraph shall be made by rule 

7 in accordance with section 553 of title 5, 

8 United States Code. 

9 ‘‘(D) EXCEPTION.—The term ‘proper 

10 name’, with respect to a biotechnology-derived 

11 therapeutic protein that was licensed by the 

12 Secretary prior to the effective date of the Af13 fordable Biologics for Consumers Act, means 

14 the name adopted for such protein by the 

15 United States Adopted Names Council, irre16 spective of whether such name is a unique 

17 USAN. 

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

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

20 product that is not a biotechnology-derived thera21 peutic protein, means— 

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

23 Secretary for such biological product pursuant 

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

25 Cosmetic Act; 


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

2 such biological product is an article recognized 

3 in an official compendium, the official title 

4 thereof in such compendium; or 

5 ‘‘(C) if neither subparagraph (A) nor sub6 paragraph (B) applies, the common or usual 

7 name, if any, of such biological product. 

8 ‘‘(m) INTERCHANGEABILITY.— 

9 ‘‘(1) IN GENERAL.— 

10 ‘‘(A) NO DESIGNATION OF INTERCHANGE11 ABILITY OR THERAPEUTIC EQUIVALENCE.—The 

12 Secretary may not designate a biosimilar as 

13 interchangeable with (or therapeutically equiva14 lent to) the applicable reference product. 

15 ‘‘(B) ASSESSMENT.—Not later than 2 

16 years after the date of enactment of this sub17 section, and every 2 years thereafter, the Sec18 retary shall assess the state of scientific and 

19 technical knowledge regarding the ability of the 

20 Food and Drug Administration to make a de21 termination that a biosimilar is interchangeable 

22 with (or therapeutically equivalent to) a ref23 erence product on a product class basis. 

24 ‘‘(2) DETERMINATION.—If the Secretary finds 

25 that the state of scientific and technical knowledge 


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1 enables the Food and Drug Administration to make 

2 a determination of interchangeability (or therapeutic 

3 equivalence) with respect to 1 or more product class4 es, then the Secretary shall submit a report to Con5 gress that describes such findings and recommenda6 tions for statutory criteria that should govern such 

7 a determination.’’. 

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

9 351 of the Public Health Service Act (42 U.S.C. 262), 

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

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

12 maintain the confidentiality of information submitted 

13 under this section for a biological product to the same ex14 tent and in the same manner as the Secretary maintains 

15 the confidentiality of information submitted under section 

16 505 of the Federal Food, Drug, and Cosmetic Act for a 

17 drug.’’. 

18 (c) PATENT ACTIONS.— 

19 (1) INFRINGEMENT ACTION.—Section 271(e)(2) 

20 of title 35, United States Code, is amended— 

21 (A) in subparagraph (A), by striking ‘‘, 

22 or’’ and inserting a comma; 

23 (B) in subparagraph (B), by striking ‘‘pat24 ent,’’ and inserting ‘‘patent, or’’; and 


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1 (C) by adding after subparagraph (B) the 

2 following: 

3 ‘‘(C) a written explanation described in 

4 section 351(k)(8)(C)(i) of the Public Health 

5 Service Act,’’. 

6 (2) PATENT TERM AUTHORITY.—Section 

7 156(b) of title 35, United States Code, is amended 

8 by adding at the end before the period, the fol9 lowing: ‘‘, and shall extend to any product that is 

10 the subject of an application approved under section 

11 351(k) of the Public Health Service Act’’. 

12 SEC. 3. AMENDMENTS TO FEDERAL FOOD, DRUG, AND COS13 METIC ACT. 

14 (a) LABELING.— 

15 (1) UNIQUE NAME.—Section 502 of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is 

17 amended by adding at the end the following: 

18 ‘‘(y) If it is a biotechnology-derived therapeutic pro19 tein, it was licensed under section 351 of the Public 

20 Health Service Act prior to the effective date of the Af21 fordable Biologics for Consumers Act, it lacks a unique 

22 USAN, and its labeling fails to bear (i) its proper name 

23 (as defined in section 351(l) of the Public Health Service 

24 Act); (ii) its brand name or phrasing, approved by the Sec25 retary, that adequately distinguishes it from other apVerDate Aug 31 2005 20:54 May 27, 2007 Jkt 059200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\S1505.IS S1505

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1 proved biotechnology-derived therapeutic proteins with the 

2 same proper name; and (iii) the following warning: ‘Any 

3 change in lllllllllll, including a change 

4 in manufacturer, should be made cautiously and only if 

5 authorized by and supervised by the prescribing health 

6 care professional.’, with the proper name of the product 

7 being inserted in the blank space. The requirement in the 

8 preceding sentence regarding the inclusion of a warning 

9 applies beginning on the date that is 180 days after the 

10 date of the enactment of the Affordable Biologics for Con11 sumers Act. 

12 ‘‘(z) If it is a biotechnology-derived therapeutic pro13 tein not subject to paragraph (y), and its labeling fails 

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

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

16 warning: ‘This product shall not be dispensed in substi17 tution for another biological product that was prescribed 

18 to be dispensed, unless such substitution was expressly au19 thorized by and is supervised by the prescribing health 

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

21 a biosimilar licensed under section 351(k) of the Public 

22 Health Service Act, the warning required by the preceding 

23 sentence shall read as follows: ‘This product shall not be 

24 dispensed in substitution for another biological product 

25 that was prescribed to be dispensed including 


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1 lllllllll.’, with the proprietary name and 

2 proper name of the reference product being inserted in the 

3 blank space. 

4 ‘‘(aa) If it is a biosimilar approved under section 

5 351(k) of the Public Health Service Act and the labeling— 

6 ‘‘(1) is inconsistent with the labeling of the ref7 erence product (as referred to in such section 

8 351(k)); 

9 ‘‘(2) does not accurately characterize the bio10 similar or account for any differences between the 

11 biosimilar and the reference product; 

12 ‘‘(3) does not describe any new data submitted 

13 in support of approval of the biosimilar since the 

14 date of approval of the reference product; 

15 ‘‘(4) does not disclose any special safety con16 cerns identified with respect to the biosimilar; or 

17 ‘‘(5) omits any safety information, such as ad18 verse events, that are identified with respect to, and 

19 included in the labeling of, the reference product, 

20 unless sponsor of such biosimilar justifies such omis21 sion to the Secretary.’’. 

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

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

24 amended by adding at the end the following: 


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27 

•S 1505 IS

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

2 a biotechnology-derived therapeutic protein licensed under 

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

4 dispensed unless the prescription specifies the drug’s pro5 prietary name or, if the drug lacks a proprietary name, 

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

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

8 preceding sentence shall be deemed to be an act which re9 sults in the drug being misbranded while held for sale.’’. 

10 SEC. 4. REPORT TO CONGRESS. 

11 Not later than 2 years after the date of the enact12 ment of this Act, and every 2 years thereafter, the Sec13 retary of Health and Human Services shall submit a re14 port to the Congress making recommendations on whether 

15 it is feasible, in the state of scientific and technical knowl16 edge (as of the date of such report), to approve applica17 tions under section 351(k) of the Public Health Service 

18 Act, as added by section 2 of this Act, for biological prod19 ucts that are claimed to be similar to vaccines, blood or 

20 plasma products or their derivatives, gene therapy, cell 

21 processing, naturally derived therapeutic proteins, or other 

22 biological products that do not contain biotechnology-de23 rived therapeutic proteins as any active ingredient. 

Æ 


sroberts on PROD1PC70 with BILLS