[Ip-health] language in the ACA on biologics Re: Will USTR undermine Obama on biosimilars at Trans-Pacific trade negotiations?
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
‘‘(1) IN GENERAL.—Any person may submit an application
for licensure of a biological product under this subsection.
‘‘(A) IN GENERAL.—
‘‘(i) REQUIRED INFORMATION.—An application submitted
under this subsection shall include information
‘‘(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
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‘‘(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;
‘‘(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
‘‘(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
‘‘(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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‘‘(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;
‘‘(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
‘‘(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
‘‘(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;*
*‘‘(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;*
*‘‘(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*
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*‘‘(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*
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.
‘‘(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.
> On Fri, May 27, 2011 at 4:08 PM, Peter Maybarduk <pmaybarduk at citizen.org
> > 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)
> > as demanded by U.S. pharmaceutical companies, according to informed
> > In a May 20 briefing for private-sector stakeholders, USTR officials
> > indicated they may propose granting as much as 12 years of data
> > for biosimilar drugs -- also known as biologics -- these sources said.
> > 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
> > 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
> > 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
> > to match the provisions of U.S. law (Inside U.S. Trade, April 29).
> > "We seek reciprocity in trade agreements," said Lila Feisee, vice
> > of global intellectual property at the Biotechnology Industry
> > "There should be reciprocity in our trade partners as well."
> > This would mean the eight other TPP parties would be expected to adopt
> > same 12-year data exclusivity period for biologics.
> > A private-sector source pointed out that the negotiating objectives in
> > 2002 fast-track law, which has expired, states that negotiators should
> > ensure that any IPR measure should "reflect a standard of protection
> > 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
> > (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
> > respect to pharmaceutical patent provisions, sources said.
> > In a related development, Assistant USTR for IPR Stan McCoy did not
> > to making a complete IPR proposal by the Vietnam round. At a May 16
> > he said it is difficult "to say with certainty what we're going to do
> > "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
> > agreement, one informed source said. That agreement, struck in 2007
> > House Democrats and the Bush administration, eased requirements for data
> > exclusivity for conventional drugs, patent linkage and patent term
> > in the FTAs with Panama, Peru and Colombia to improve access for
> > medicines.
> > The official said that "2007 was 2007," and "2011 is 2011," in an
> > signal that the 2007 deal as negotiated is not directly relevant for the
> > deal, sources said.
> > For instance, USTR noted that new domestic legislation, such as the
> > care reform bill establishing a 12-year data exclusivity for biologics,
> > one example of how the circumstances differ now when considering whether
> > 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
> > 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
> > 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
> Ip-health mailing list
> Ip-health at lists.keionline.org
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
More information about the Ip-health