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Biosimilars 2009 Update Pending Legislation Review. Pam Politis AIPLA Spring Meeting 2009 May 14, 2009. Follow-on Biologics Bills in the House of Representatives 2009. H.R. 1427 Waxman Bill. H.R. 1545 Eshoo Bill. Pathway for Biosimilars Act Introduced March 17, 2009

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Biosimilars 2009 Update Pending Legislation Review


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    1. Biosimilars 2009 UpdatePending Legislation Review Pam Politis AIPLA Spring Meeting 2009May 14, 2009

    2. Follow-on Biologics Bills in the House of Representatives 2009 H.R. 1427 Waxman Bill H.R. 1545 Eshoo Bill Pathway for Biosimilars Act Introduced March 17, 2009 Amendment to Public Health Services Act 42 U.S.C. § 262 Supported by PhRMA, BIO • Promoting Innovation and Access to Life-Saving Medicine Act • Introduced March 11, 2009 • Amendment to Public Health Services Act 42 U.S.C. § 262 • Supported by GPhA, AARP, Labor Unions, Managed Care Groups

    3. Follow-on Biologics Bills-Similarities • Permit follow-on applicant to reference Approved Product Data • Two Possible Designations with Approval: Biosimilar and Interchangeable • Application Data • Biosimilar • Analytical Studies-chemical, physical, biological • Animal studies • Necessary clinical studies to demonstrate safety, purity, and potency* *Eshoo Bill requires trials for the purpose of assessing immunogenicity.

    4. Follow-on Biologics Bills-Similarities Definition of Biosimilar H.R. 1427 Waxman Bill H.R. 1545 Eshoo Bill Biosimilar: “highly similar” to reference product. • Biosimilar: “no clinically meaningful differences between the biological product and the reference product would be expected in terms of the safety, purity, and potency if treatment were to be initiated with the biological product instead of the reference product.”

    5. Follow-on Biologics Bills-Interchangeable H.R. 1427 Waxman Bill H.R. 1545 Eshoo Bill Interchangeable Biological Product: Biosimilar to reference product and all other interchangeable products; All approved uses of the reference product; Can safely “switch” patients Final guidance on interchangeability of the product class. • Interchangeable Biological Product: • Biosimilar to reference product; • Can safely “switch” patients

    6. Follow-on Biologics Bills-Market Exclusivity FDA will NOT APPROVE FOB Application H.R. 1427 Waxman Bill 12 years Extendable by 2 years if extension is requested during first 8 years after approval At least 4 years DATA exclusivity FDA must have initiated guidance proceedings H.R. 1545 Eshoo Bill • 5 years • extendable by 6 months • 3 years for Similar Substance • Exclusivity Adjustment • 6 month extension limited for products with annual gross U.S. sales of over $1 billion.

    7. Follow-on Biologics Bills-Patent Notices NO ORANGE BOOK! H.R. 1427 Waxman Bill Disclosure Burden on FOB Applicant FOB sends application to RP sponsor w/in 30 days RP sponsor sends list of patents (60 days) FOB certifies (30 days) 3rd Party Patents Too!!! H.R. 1545 Eshoo Bill • Reference Product Holder Burden to Disclose • Notice is Discretionary! • FOB Applicant asks for Patent information from RP sponsor • RP Sponsor MUST identify all “related patents” • Must update for 2 years • Anytime after FOB application is filed, FOB may send notice.*

    8. Follow-on Biologics Bills-Patent Suits NO 30 month stay! H.R. 1427 Waxman Bill Trial court decision of infringement prevents FDA approval until patent expires. No possibility of “at risk” launch for RP who wins trial court decision. FOB cannot bring DJ action until 3 years prior to market exclusivity expiration. Third Parties Too! H.R. 1545 Eshoo Bill • Within 45 days of receiving notice, RP Holder may file suit • Only for patents in notice, i.e. those patents the FOB applicant selected. • If no suit on notice patents FOB applicant may bring DJ action • If no suit in 45 day period, any later suit limited to reasonable royalities. • Not Listed = No Suit!

    9. Follow-on Biologics Bills- DIFFERENCES BIAS in the details! H.R. 1427 Waxman Bill Biosimilarity and Interchangeability must be demonstrated for every use in the reference product label. Guidance Documents Required for Each Product Class!! Every biological product has unique official name. H.R. 1545 Eshoo Bill • FOB can pick one indication for approval • Reduces clinical trial burden without market consequence. • Guidance Document to be issued, but not required for approval. • Biosimilar has same official name as reference product • NO Auth. Biosimilars during exclusivity period.

    10. Canada-Subsequent Entry Biologics • Detailed Guidance Issued March 27 ,2009 • Detailed expectations for data comparisons between SEB and reference product. • Importance of manufacturing and Quality data stressed • Allows for “Biosimilar” designation, not interchangeable. • SEB must create independent label, setting forth data supporting similarity to reference product. • No claims for bioequivalence or therapeutic equivalence may be made In the label. • Provides 6 years data exclusivity • Patent Notice and litigation provisions identical to generic drug pathway (same as Hatch-Waxman) • First SEB (Omnitrope™) approved April 22, 2009