[Ip-health] language in the ACA on biologics Re: Will USTR undermine Obama on biosimilars at Trans-Pacific trade negotiations?

Ellen Shaffer ershaffer at gmail.com
Fri May 27 21:15:11 PDT 2011


I believe this is it:

*751 PPACA (Consolidated) Sec. 7002*
*SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL PRODUCTS.*

*(a) L**ICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR
*

*I**NTERCHANGEABLE**.—Section 351 of the Public Health Service Act*

*(42 U.S.C. 262) is amended—*

(1) in subsection (a)(1)(A), by inserting ‘‘under this subsection

or subsection (k)’’ after ‘‘biologics license’’; and

(2) by adding at the end the following:

‘‘(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR

INTERCHANGEABLE.—

‘‘(1) IN GENERAL.—Any person may submit an application

for licensure of a biological product under this subsection.

‘‘(2) CONTENT.—

‘‘(A) IN GENERAL.—

‘‘(i) REQUIRED INFORMATION.—An application submitted

under this subsection shall include information

demonstrating that—

‘‘(I) the biological product is biosimilar to a

reference product based upon data derived from—

‘‘(aa) analytical studies that demonstrate

that the biological product is highly similar to

the reference product notwithstanding minor

differences in clinically inactive components;

‘‘(bb) animal studies (including the assessment

of toxicity); and

‘‘(cc) a clinical study or studies (including

the assessment of immunogenicity and pharmacokinetics

or pharmacodynamics) that are

sufficient to demonstrate safety, purity, and

potency in 1 or more appropriate conditions of

use for which the reference product is licensed

and intended to be used and for which licensure

is sought for the biological product;

‘‘(II) 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;

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(Consolidated) 748
*

‘‘(III) 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;

‘‘(IV) the route of administration, the dosage

form, and the strength of the biological product

are the same as those of the reference product;

and

‘‘(V) 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.

‘‘(ii) DETERMINATION BY SECRETARY.—The Secretary

may determine, in the Secretary’s discretion,

that an element described in clause (i)(I) is unnecessary

in an application submitted under this subsection.

‘‘(iii) ADDITIONAL INFORMATION.—An application

submitted under this subsection—

‘‘(I) shall include publicly-available information

regarding the Secretary’s previous determination

that the reference product is safe, pure, and

potent; and

‘‘(II) may include any additional information

in support of the application, including publiclyavailable

information with respect to the reference

product or another biological product.

‘‘(B) INTERCHANGEABILITY.—An application (or a supplement

to an application) submitted under this subsection

may include information demonstrating that the biological

product meets the standards described in paragraph (4).

‘‘(3) EVALUATION BY SECRETARY.—Upon review of an application

(or a supplement to an application) submitted under this

subsection, the Secretary shall license the biological product

under this subsection if—

‘‘(A) the Secretary determines that the information

submitted in the application (or the supplement) is sufficient

to show that the biological product—

‘‘(i) is biosimilar to the reference product; or

‘‘(ii) meets the standards described in paragraph

(4), and therefore is interchangeable with the reference

product; and

‘‘(B) the applicant (or other appropriate person) consents

to the inspection of the facility that is the subject of

the application, in accordance with subsection (c).

‘‘(4) SAFETY STANDARDS FOR DETERMINING INTERCHANGEABILITY.—

Upon review of an application submitted under this

subsection or any supplement to such application, the Secretary

shall determine the biological product to be interchangeable

with the reference product if the Secretary determines

that the information submitted in the application (or a supplement

to such application) is sufficient to show that—

‘‘(A) the biological product—
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9001 Sfmt 6601 F:\P11\NHI\COMP\PPACACON.
‘‘(i) is biosimilar to the reference product; and

‘‘(ii) can be expected to produce the same clinical

result as the reference product in any given patient;

and

‘‘(B) 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.

‘‘(5) GENERAL RULES.—

‘‘(A) ONE REFERENCE PRODUCT PER APPLICATION.—A

biological product, in an application submitted under this

subsection, may not be evaluated against more than 1 reference

product.

‘‘(B) REVIEW.—An application submitted under this

subsection shall be reviewed by the division within the

Food and Drug Administration that is responsible for the

review and approval of the application under which the

reference product is licensed.

‘‘(C) RISK EVALUATION AND MITIGATION STRATEGIES.—

The authority of the Secretary with respect to risk evaluation

and mitigation strategies under the Federal Food,

Drug, and Cosmetic Act shall apply to biological products

licensed under this subsection in the same manner as such

authority applies to biological products licensed under subsection

(a).

‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL

PRODUCT.—Upon review of an application submitted under this

subsection relying on the same reference product for which a

prior biological product has received a determination of interchangeability

for any condition of use, *the Secretary shall not*

*make a determination under paragraph (4) that the second or*

*subsequent biological product is interchangeable for any condition*

*of use until the earlier of—*

*‘‘(A) 1 year after the first commercial marketing of the*

*first interchangeable biosimilar biological product to be approved*

*as interchangeable for that reference product;*

*‘‘(B) 18 months after—*

*‘‘(i) a final court decision on all patents* *in suit in*

*an action instituted under subsection (l)(6) against the*

*applicant that submitted the application for the first*

*approved interchangeable biosimilar biological product;*

*or*

*‘‘(ii) the dismissal with or without prejudice of an*

*action instituted under subsection (l)(6) against the*

*applicant that submitted the application for the first*

*approved interchangeable biosimilar biological product;*

*or*

*‘‘(C)(i) 42 months after approval of the first interchangeable*

*biosimilar biological product if the applicant*

*that submitted such application has been sued under subsection*

*(l)(6) and such litigation is still ongoing within*

*such 42-month period; or*

*VerDate 0ct 09 2002 13:03 Jun 09, 2010 Jkt 000000 PO 00000 Frm 00749 Fmt
9001 Sfmt 6601 F:\P11\NHI\COMP\PPACHOLCPC*
**
*‘‘(ii) 18 months after approval of the first interchangeable*

*biosimilar biological product if the applicant that submitted*

*such application has not been sued under subsection*

(l)(6).

For purposes of this paragraph, the term ‘final court decision’

means a final decision of a court from which no appeal (other

than a petition to the United States Supreme Court for a writ

of certiorari) has been or can be taken.

*‘‘(7) E**XCLUSIVITY FOR REFERENCE PRODUCT**.—*

*‘‘(A) E**FFECTIVE DATE OF BIOSIMILAR APPLICATION APPROVAL**.—*

*Approval of an application under this subsection*

*may not be made effective by the Secretary until the date*

*that is 12 years after the date on which the reference product*

*was first licensed under subsection (a).*

‘‘(B) FILING PERIOD.—An application under this subsection

may not be submitted to the Secretary until the

date that is 4 years after the date on which the reference

product was first licensed under subsection (a).

‘‘(C) FIRST LICENSURE.—Subparagraphs (A) and (B)

shall not apply to a license for or approval of—

‘‘(i) a supplement for the biological product that is

the reference product; or

‘‘(ii) a subsequent application filed by the same

sponsor or manufacturer of the biological product that

is the reference product (or a licensor, predecessor in

interest, or other related entity) for—

‘‘(I) a change (not including a modification to

the structure of the biological product) that results

in a new indication, route of administration, dosing

schedule, dosage form, delivery system, delivery

device, or strength; or

‘‘(II) a modification to the structure of the biological

product that does not result in a change in

safety, purity, or potency.

‘‘(8) GUIDANCE DOCUMENTS.—

‘‘(A) IN GENERAL.—The Secretary may, after opportunity

for public comment, issue guidance in accordance,

except as provided in subparagraph (B)(i), with section

701(h) of the Federal Food, Drug, and Cosmetic Act with

respect to the licensure of a biological product under this

subsection. Any such guidance may be general or specific.

‘‘(B) PUBLIC COMMENT.—

‘‘(i) IN GENERAL.—The Secretary shall provide the

public an opportunity to comment on any proposed

guidance issued under subparagraph (A) before

issuing final guidance.

‘‘(ii) INPUT REGARDING MOST VALUABLE GUIDANCE.—

The Secretary shall establish a process

through which the public may provide the Secretary

with input regarding priorities for issuing guidance.

‘‘(C) NO REQUIREMENT FOR APPLICATION CONSIDERATION.—

The issuance (or non-issuance) of guidance under

subparagraph (A) shall not preclude the review of, or action

on, an application submitted under this subsection.

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‘‘(D) REQUIREMENT FOR PRODUCT CLASS-SPECIFIC GUIDANCE.—

If the Secretary issues product class-specific guidance

under subparagraph (A), such guidance shall include

a description of—

‘‘(i) the criteria that the Secretary will use to determine

whether a biological product is highly similar

to a reference product in such product class; and

‘‘(ii) the criteria, if available, that the Secretary

will use to determine whether a biological product

meets the standards described in paragraph (4).

‘‘(E) CERTAIN PRODUCT CLASSES.—

‘‘(i) GUIDANCE.—The Secretary may indicate in a

guidance document that the science and experience, as

of the date of such guidance, with respect to a product

or product class (not including any recombinant protein)

does not allow approval of an application for a license

as provided under this subsection for such product

or product class.

‘‘(ii) MODIFICATION OR REVERSAL.—The Secretary

may issue a subsequent guidance document under

subparagraph (A) to modify or reverse a guidance document

under clause (i).

‘‘(iii) NO EFFECT ON ABILITY TO DENY LICENSE.—

Clause (i) shall not be construed to require the Secretary

to approve a product with respect to which the

Secretary has not indicated in a guidance document

that the science and experience, as described in clause

(i), does not allow approval of such an application.

‘‘(l) PATENTS.—

‘‘(1) CONFIDENTIAL ACCESS TO SUBSECTION (k) APPLICATION


On Fri, May 27, 2011 at 8:37 PM, Ruth Lopert <ruth.lopert at gmail.com> wrote:

> Oh my. Actually the PPACA provides only 4 years of data exclusivity, but 12
> years of market exclusivity (12 years of data exclusivity would be even
> worse)  And they are not patent protections. And the exclusivity applies to
> the originator, not the biosimilar.
>
> And they wont get it anyway.
>
> RL
>
> On Fri, May 27, 2011 at 4:08 PM, Peter Maybarduk <pmaybarduk at citizen.org
> >wrote:
>
> > Inside U.S. Trade - 05/27/2011
> > USTR Signals Support For Longer Data Protection For Biologics In TPP
> > Posted: May 26, 2011
> > The Office of the U.S. Trade Representative signaled last week it will
> > pursue stronger patent protections for biosimilar drugs than for
> > conventional medicines in the Trans-Pacific Partnership (TPP)
> negotiations,
> > as demanded by U.S. pharmaceutical companies, according to informed
> sources.
> >
> > In a May 20 briefing for private-sector stakeholders, USTR officials
> > indicated they may propose granting as much as 12 years of data
> exclusivity
> > for biosimilar drugs -- also known as biologics -- these sources said.
> The
> > officials, however, did not fully commit to doing so, they said.
> >
> > A 12-year data exclusivity period would reflect provisions in the U.S.
> > health care reform bill that was signed into law last year. At the same
> > time, the officials said they were aware of the fact that President
> Obama's
> > fiscal year 2012 budget proposal called for a reduction of the data
> > exclusivity period for biologics to seven years.
> >
> > Either of these periods would be a jump up from the five years of data
> > exclusivity for pharmaceuticals that the United States has negotiated in
> > past trade deals.
> >
> > During the data exclusivity period, generic drug manufacturers are barred
> > from accessing the clinical data typically generated by brand-name drug
> > companies. This delays the marketing of cheaper, generic competitor
> drugs.
> >
> > The Pharmaceutical Research and Manufacturers of America (PhRMA), the
> > Biotechnology Industry Organization (BIO) and others are urging USTR to
> > secure 12 years of data exclusivity for biologics in the TPP talks in
> order
> > to match the provisions of U.S. law (Inside U.S. Trade, April 29).
> >
> > "We seek reciprocity in trade agreements," said Lila Feisee, vice
> president
> > of global intellectual property at the Biotechnology Industry
> Organization.
> > "There should be reciprocity in our trade partners as well."
> >
> > This would mean the eight other TPP parties would be expected to adopt
> the
> > same 12-year data exclusivity period for biologics.
> >
> > A private-sector source pointed out that the negotiating objectives in
> the
> > 2002 fast-track law, which has expired, states that negotiators should
> > ensure that any IPR measure should "reflect a standard of protection
> similar
> > to that found in United States law."
> >
> > The USTR officials in the briefing did not say for certain whether the
> > United States will table a complete proposal on intellectual property
> rights
> > (IPR) before the next round of TPP negotiations in Vietnam scheduled for
> > mid-June, but signaled that they are working toward this goal, at least
> with
> > respect to pharmaceutical patent provisions, sources said.
> >
> > In a related development, Assistant USTR for IPR Stan McCoy did not
> commit
> > to making a complete IPR proposal by the Vietnam round. At a May 16
> event,
> > he said it is difficult "to say with certainty what we're going to do
> when."
> >
> > "The next round will be in Vietnam and we're looking at what we can table
> > for that round and it's all kind of an ongoing process inside the
> > administration," McCoy said. USTR has already tabled most of its proposed
> > IPR text, but has not yet tabled the most crucial provisions on patent
> > protections and other IPR topics.
> >
> > At the briefing, one USTR official made it "very clear" that the U.S.
> > government does not intend to replicate the patent provisions in the May
> 10
> > agreement, one informed source said. That agreement, struck in 2007
> between
> > House Democrats and the Bush administration, eased requirements for data
> > exclusivity for conventional drugs, patent linkage and patent term
> extension
> > in the FTAs with Panama, Peru and Colombia to improve access for
> affordable
> > medicines.
> >
> > The official said that "2007 was 2007," and "2011 is 2011," in an
> apparent
> > signal that the 2007 deal as negotiated is not directly relevant for the
> TPP
> > deal, sources said.
> >
> > For instance, USTR noted that new domestic legislation, such as the
> health
> > care reform bill establishing a 12-year data exclusivity for biologics,
> is
> > one example of how the circumstances differ now when considering whether
> the
> > May 10 standards are still relevant for TPP, sources said.
> >
> > The pharmaceutical industry has launched a major lobbying campaign to get
> > USTR to disregard the May 10 deal and make the U.S.-Korea FTA the basis
> of
> > its TPP proposals on pharmaceuticals (Inside U.S. Trade, April 29).
> >
> > In the briefing, USTR said that it has not yet tabled text on
> > pharmaceutical pricing and reimbursement policies, but said it is under
> > consideration. But USTR gave no clues on whether such provisions would
> stand
> > as a separate chapter or if they would be included in other chapters,
> > sources said.
> >
> > Industry wants these provisions to be included as a way to mandate more
> > transparency for or altogether counteract national drug pricing programs,
> > which they say can restrict market access and profits for U.S. drug
> > companies.
> >
> > _______________________________________________
> > Ip-health mailing list
> > Ip-health at lists.keionline.org
> >
> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
> >
> _______________________________________________
> Ip-health mailing list
> Ip-health at lists.keionline.org
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>



-- 
Ellen R. Shaffer, PhD MPH
Co-Director, Center for Policy Analysis/EQUAL/CPATH
San Francisco Presidio
P.O. Box 29586
San Francisco, CA 94129-0586
Phone 415-922-6204
www.centerforpolicyanalysis.org
www.cpath.org
cell: 415-680-4603



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