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Our Patients Our People Our Business Biosimilars 2009 Update Pending Legislation Review Pam Politis Our Patients Our People Our Business Biosimilars 2009 Update Pending Legislation Review Pam Politis AIPLA Spring Meeting 2009 May 14, 2009 © 2008 Endo Pharmaceuticals. All Rights Reserved. Our Community

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

Follow-on Biologics Bills-Similarities • Permit follow-on applicant to reference Approved Product Data • Two 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. 3

Follow-on Biologics Bills-Similarities DEFINITION OF BIOSIMILAR H. R. 1427 Waxman Bill H. R. 1545 Follow-on Biologics Bills-Similarities DEFINITION OF BIOSIMILAR H. R. 1427 Waxman Bill H. R. 1545 Eshoo Bill • Biosimilar: “no clinically • Biosimilar: “highly meaningful differences similar” to reference 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. ” 4

Follow-on Biologics Bills-INTERCHANGEABLE H. R. 1545 Eshoo Bill • Interchangeable Biological Product: H. R. Follow-on Biologics Bills-INTERCHANGEABLE H. R. 1545 Eshoo Bill • Interchangeable Biological Product: H. R. 1427 Waxman 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. – Biosimilar to reference product; – Can safely “switch” patients 5

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

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

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

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

Canada-Subsequent Entry Biologics • Detailed Guidance Issued March 27 , 2009 – Detailed expectations 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 10