1. Copyright © 2010 by K&L Gates LLP. All rights reserved. The Biosimilars Act—A Basic Introduction Michael H. Hinckle K&L Gates Research Triangle Park, NC (919) 466-1115 michael.hinckle@klgates.com

2. 1 Background  Small molecule drugs approved under the Federal Food, Drug, and Cosmetic Act  Generic process available (ANDA)  Biologics licensed under the Public Health Service Act  Until recently, no “generic” process available  “Biologics Price Competition and Innovation Act” (enacted as Title VII of the Patient Protection and Affordable Care Act) created a pathway for FDA to approve competing versions of currently marketed biologic drugs.

3. 2 Biosimilar Approvals  Approval Pathways  Biosimilar  “highly similar” except for “minor differences in clinically inactive components”  same mechanism of action (if known), route of admin, dosage form, strength, and labeling  requires (unless waived) analytical, animal, and one or more clinical studies  Interchangeable  Biosimilar plus “expected to produce same clinical result …in any given patient”  for products administered more than once—no reduction in safety or efficacy when alternating or switching between biosimilar and reference product.  requirements left to FDA

4. 3 Data and Market Exclusivity  Reference Products  12 years market exclusivity  4 years data exclusivity  No exclusivity for supplements, new indications, dosing schedules, dosage forms, delivery systems/devices or strengths  But, exclusivity for “modification to structure” that results in change in safety, purity or potency  First Interchangeable Biosimilar Product  Up to one year of being only interchangeable product  Can be shortened if unable to launch

5. 4 Key Elements of Patent Dispute Process  Full application submitted to reference sponsor  Exchange of Patent lists and detailed statements  “Patent Resolution Negotiation”  Designation of Patents for Litigation—biosimilar applicant controls the number of patents that may be listed by each side  No “30-month stay” of biosimilar approval  But, second bite at the apple—biosimilar applicant must give 180 days notice prior to launch and reference sponsor may seek P.I. on ANY patent that was on its initial list.

6. 5 Michael H. Hinckle K&L Gates LLP Research Triangle Park, NC (919) 466-1115 michael.hinckle@klgates.com