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E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP US Regulatory Pathway For Biosimilars Practical Legal/Regulatory Considerations Arising In The Course Of The Pathway’s Implementation John M. Engel, Esq. Managing Partner E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE AIPLA - American Intellectual Property Law Association Biotechnology Committee Webinar 25 September 2012
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP DISCLAIMER The Material And Viewpoints Set Forth In This Slide Deck And Conveyed During The Presentation Are Presented By The Author In His Capacity As Founding & Managing Partner Of Engel & Novitt, LLP. They Do Not Represent And Do Not Purport To Represent The Views Of The Law Firm Or Of Any Former, Current Or Prospective Client Of The Firm, And Should Not Be Construed As Such. This Presentation Does Not Provide Legal Advice, And Nothing In This Presentation Constitutes Legal Advice, Which Should Be Sought From Independently Engaged Legal Counsel Based Upon Individual Circumstances. 2 US Statutory Framework For Biosimilars US Regulatory Framework For Biosimilars Practical Considerations In Implementation 351(k) vs. 351(a) What’s In A Name? Do Constitutional (Takings) Issues Remain? How Safe Is The 271(e)(1) Safe Harbor? Surviving A Rube Goldberg-Like Patent Scheme Further Reading That Might Be Of Interest P RESENTATION O UTLINE – US B IOSIMILARS P ATHWAY
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP US Statutory Framework For Biosimilars (1) Biosimilars pathway enacted as part of health-care reform,Biosimilars pathway enacted as part of health-care reform, Patient Protection & Affordable Care Act, Public Law No , 124 STAT (23 March 2010) –Available at =111_cong_public_laws&docid=f:publ pdfhttp://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname =111_cong_public_laws&docid=f:publ pdf The “Biologics Price Competition and Innovation Act” (Title VII, Subtitle A) establishes “biosimilars pathway” –Derived from unamended, Senate-passed BPCIA (S. 1695) adopted in 110 th Congress by Senate HELP Committee (27 June 2007; reported 19 Nov 2008) Grants FDA express new authority to review applications for, license, and regulate biosimilar biological products –New PHS Act provisions for biosimilars are much more explicit and detailed than 50-plus yr-old provisions for originator BLAs 3
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP US Statutory Framework For Biosimilars (2) A “biosimilar” is a biological product that is –Highly similar in quality attributes to the reference, with minor differences in clinically inactive components OK –Has no clinically meaningful differences from the reference in terms of safety, purity, and potency An “interchangeable biosimilar” is a biologic that is –Biosimilar to the reference biological product –Expected to produce same clinical result in any given patient –During repeat administration, presents no greater risk in terms of safety or diminished efficacy from alternating or switching products than use of reference without switching “Interchangeable”/”Interchangeability” mean the biosimilar may be substituted for reference without the intervention of the health care provider who prescribed the reference 4
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP Biosimilar is limited to single reference biologic (RB) Biosimilar must rely on FDA’s prior S&E finding for RB Biosimilar sponsors effectively follow two-step process: 1)Biosimilarity based on specific statutory requirements Analytics, preclinical, & clinical studies incl. immunogenicity Any of these can be waived by FDA 2)Interchangeability presumably based on switching studies Biosimilar sponsors can pursue a subset of indications Clinical studies in all uses not mandated if MoA is shared –Facilitates extrapolation consistent with sound science Biosimilar applications can proceed w/out FDA guidance Biosimilars must follow standard biologics’ requirements –User fees, risk-mitigation strategies, etc. 5 US Statutory Framework For Biosimilars (3)
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP FDA issued three draft biosimilar guidances (Feb. 2012) 1)Scientific Considerations in Demonstrating Biosimilarity to a Reference Product 2)Biosimilars: Q&A Regarding Implementation of the Biologics Price Competition and Innovation Act of )Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product –NOTE: AIPLA submitted comments on all three guidances addressing issues impacting IP rights (focusing on 12-year exclusivity for biologics) Three draft biosimilar guidances focus on technical regulatory aspects of biosimilar development and review –Characterizing a proposed biosimilar product and the reference product [Scientific Considerations; Quality Considerations] –Delineating necessary data, such as pharmacokinetic/ pharmacodynamic, preclinical, and clinical data [Scientific Considerations; Q&A] –Answering common questions regarding FDA’s interpretation of certain statutory terms and requirements [Q&A] 6 US Regulatory Framework For Biosimilars (1)
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP FDA’s stated goal in issuing guidances is an efficient, predictable, and transparent regulatory pathway FDA convened public hearing on guidances (May 2012) At public hearing, FDA heard testimony on these issues and also sought stakeholder input on future guidances – 351(k) applications seeking a determination of interchangeability – Requests for reference product exclusivity – Naming issues – Clinical pharmacology evaluation of biosimilar products – Q&As regarding implementation of BPCI Act (next set of Q&As) Guidances not yet finalized heading into FY‘13 As new Fiscal Year approaches (Oct 1 st ), FDA has said it is working “diligently” to finalize the guidances, but timeline not provided 7 US Regulatory Framework For Biosimilars (2)
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP Debate persists over the viability of the biosimilars pathway and the value of pursuing approval of a biological product under 351(k) rather than 351(a) –Significant questions remain as to whether the regulatory burden and timelines for development and approval of a 351(k) biosimilar are that much less than those for development and approval of a traditional 351(a) –Any approved biosimilar is not expected to be interchangeable with its reference, thus requiring a sales force like a traditional 351(a) biologic –FDA itself recently has warned that the biosimilars program will be “under-resourced” for the next several years because user fees will accrue slowly over time given the absence of established facilities/products, and Congress did include biosimilar user fees in the recently-passed CR –FDA already has demonstrated the capacity to a biosimilar-like 351(a) BLA Teva’s BLA (125294) for Neutroval® (tbo-filgrastim) approved 8/29/12 Pre-BPCIA BLA based upon Teva’s biosimilar approved in the EU with clinicals using a foreign (non-U.S.-approved) filgrastim comparator 8 Practical Considerations In Implementation: 351(k) vs. 351(a)
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP High-pitched debate about biosimilars sharing the same names as their reference products continues to escalate –The BPCIA includes no provision on USANs/INNs/established names for biosimilars, and FDA’s draft guidances are silent on naming –Originators generally contend that, because biosimilars are merely similar and not the same, biosimilars must have distinctive names to be distinguished from their counterparts to prevent marketplace confusion, enable track and trace, and facilitate pharmacovigilance –Biosimilar companies generally contend that, as with other highly similar biological products, a biosimilar should carry the identical USAN/INN/ established name as its reference product in order to minimize confusion and mitigate counter-detailing, with pharmacovigilance managed as it always has been using NDCs and lot #s –In approving Neutroval®, FDA went to great lengths to underscore that the “requirement for a unique nonproprietary name,” tbo-filgrastim, “is separate from any future decision FDA will make regarding the naming scheme for biosimilar and interchangeable products” 9 Practical Considerations In Implementation: What’s In A Name?
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP Although Chief Justice Roberts’ Opinion in NFIB et al. v Sebelius has taken the PPACA constitutional limelight, a separate constitutional claim is percolating at FDA –On April 2, 2012, Abbott Laboratories filed a Citizen’s Petition presenting various Fifth Amendment Takings claims challenging the BPCIA on its face and as applied to Abbott’s Humira® (adalimumab) or any other biological product approved pursuant to a BLA prior to the BPCIA’s enactment date –In at least three pre-BPCIA administrative decisions, and, importantly, one post-BPCIA decision issued just two months prior to Abbott’s Petition, FDA previously has rejected all such Takings claims –Applying the Supreme Court’s regulatory-taking decisions in Ruckelshaus v. Monsanto Co. (1984) and its progeny, it is unclear whether a colorable Takings claim can be established under the BPCIA, which does not require disclosure of trade secret data to third parties like biosimilar applicants –Abbott’s Petition does not address its post-enactment concession (in an 2010 docket submission) as to the absence of any Takings claims as a result of the “just compensation” Congress bestowed in the BPCIA 10 Practical Considerations In Implementation: Do Constitutional (Takings) Issues Remain?
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP Conflicting 2-1 decisions by two CAFC panels have opened debate on the 271(e)(1) safe harbor’s application –In Classen Immunotherapies, Inc. v. Biogen Idec ( , 8/31/11), the panel ruled that 271(e)(1) safe harbor did not apply to patented methods used in studies to evaluate the correlation between child vaccination schedules and the incidence of immune-mediated disorders, because activities involved information routinely reported to FDA post-approval Petition for a writ of certiorari is pending before the Supreme Court –In Momenta Pharmaceuticals v. Amphastar Pharmaceuticals ( , 8/3/12), another panel distinguished Classen and held, over Chief Judge Rader’s dissent, that batch testing methods for enoxaparin (a biological drug regulated under the FD&C Act) were pivotal to the alleged infringer’s “very ability to continue its FDA approval” and manufacturing/marketing Opinion by Judge Moore (dissenter in Classen); Chief Judge Rader (who had been in majority in Classen) suggested an en banc hearing –These rulings, and any decision forthcoming from the Supreme Court, could have potentially-significant implications for biosimilars given analytical-method patents claiming FDA-mandated testing methods 11 Practical Considerations In Implementation: How Safe Is The 271(e)(1) Safe Harbor?
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP Practical Considerations In Implementation: Surviving A Rube Goldberg-Like Patent Scheme (Making “Apple v. Samsung” Litigation Look Simple By Comparison) 12 FDA files the Subsection (k) biosimilar BLA (accepts it for review) 20 Days Subsection (k) biosimilar BLA applicant notifies reference biologic BLA holder & provides copy of BLA & entire mf’g process 60 Days Reference biologic BLA holder provides list of patents it “reasonably believes would be” infringed to Subsection (k) biosimilar BLA applicant, identifying those prepared to license 60 Days Subsection (k) biosimilar BLA applicant provides detailed statement to reference biologic BLA holder: it “does not intend” to market pre-expiry; or asserting non-infringement, invalidity, unenforceability 60 Days Reference biologic BLA holder responds to Subsection (k) biosimilar BLA applicant’s statements Negotiations If negotiations fail (presumed) 15 Days5 Days Subsection (k) biosimilar BLA applicant notifies reference biologic BLA holder of # of patents to be litigated Parties exchange lists of patents to be litigated 30 Days Reference biologic BLA holder must initiate “immediate” infringement action Nebulous Negotiation Trigger
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP Further Reading That Might Be Of Interest Most recently-published manuscripts presenting additional background and analysis from this author’s perspective: John M. Engel, Biosimilars Approvals In The US: The Path Forward, Biopharm International (Sep. 2010): (addressing the law’s unprecedented patent provisions) (Available at John M. Engel, Biosimilars In The US: Applying Europe’s Leadership on Biosimilars & FDA’s Century Of Experience Implementing The Broad Provisions Of The PHS Act, DIA Global Forum EGA Special Issue (Vol. 3, Feb. 2011):30-34 (addressing the global comparability (highly similar) standard applied to all biological products) (Available at (Restricted Access – DIA Members) 13
E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S CIENCE © E&N LLP Thank You! Any Questions? 14 John M. Engel, Esq. Managing Partner E NGEL & N OVITT, LLP T HE L AW F IRM T HAT K NOWS I TS S (Direct) (Mobile) 2401 Pennsylvania Avenue, N.W., Suite # 310 Washington, DC
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