Strategies for Developing & Commercializing Biobetters & Biosimilars

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Strategies for Developing & Commercializing Biobetters & Biosimilars a presentation by Phil Smith, PhD, Founder, PNPSmith Advisors, LLC at PODD Partnership Opportunites in Drug Delivery 2012, Boston, MA

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Strategies for Developing & Commercializing Biobetters & Biosimilars

  1. 1. STRATEGIES FOR DEVELOPING AND COMMERCIALIZING BIOSIMILARS & BIOBETTERS From http://www.rebismart.ca  FDA Draft Guidelines for Biosimilars available (http://www.fda.gov/Drugs/G uidanceComplianceRegulato ryInformation/Guidances/uc m290967.htm)  Majority of biologics delivered by injection  Device evolution continues to progress/generate market share
  2. 2. STRATEGIES FOR DEVELOPING AND COMMERCIALIZING BIOSIMILARS & BIOBETTERS  Section 505 of the Food, Drug and Cosmetic Act NDA – 505(b)(1): Full application NDA – 505(b)(2): Hybrid application which relies on previous approvals but may also include clinical trials ANDA – 505(j): Abbreviated application requiring only bioequivalence trials  Section 351 of the Public Health Service Act (PHSA) BLA – 351(a): Full application BLA – 351(k): Biosimilar application (added by Biologics Price Competition and Innovation Act – BPCIA) a. Biosimilar b. Interchangeable Information from FDA website
  3. 3. STRATEGIES FOR DEVELOPING AND COMMERCIALIZING BIOSIMILARS & BIOBETTERS  Totality of Evidence  Structural and Functional Characterization  Human Pharmacokinetics and Pharmacodynamics  Clinical Knowledge e.g. Post- Market Experience  Clinical Immunogenicity  Animal Sutides  Clinical  No ‘one size fits all’ assessment: FDA scientists will evaluate the applicants integration of various types of information to provide advice on scope and extent of development plan and, ultimately, an overall assessment that a biological product is (or is not) biosimilar to an approved reference product. Information from FDA website
  4. 4. ‘A proposed biosimilar product in a delivery device will be considered a combination product and may, in some instances require a separate application for the device’ ‘some design differences in the delivery device or container closure system used with the proposed biosimilar product may be acceptable’ STRATEGIES FOR DEVELOPING AND COMMERCIALIZING BIOSIMILARS & BIOBETTERS Information from FDA website
  5. 5. STRATEGIES FOR DEVELOPING AND COMMERCIALIZING BIOSIMILARS & BIOBETTERS  Jim Roach, MD, SVP Development and Chief Medical Officer, Momenta  Magdalena Leszczymiecka, PhD, MBA, Founder and CEO STC Biologics  Barbara Rosengren, MBA, VP Strategic Product Development, Momenta  Ashley Lawton, PhD, MBA, Sr. Director, Business Development, Shire HGT  Philip Smith, PhD, Consultant, PNPSmith Advisors
  6. 6. Questions
  7. 7. Q. I.4. Can a proposed biosimilar product have a delivery device or container closure system that is different from its reference product? 7 A. I.4. (Proposed Answer): Yes, some design differences in the delivery device or container closure system used with the proposed biosimilar product may be acceptable. It may be possible, for example, for an applicant to obtain licensure of a proposed biosimilar product in a pre-filled syringe or in an auto-injector device (which are considered the same “injectable” dosage form), even if the reference product is licensed in a vial presentation, provided that the proposed product meets the statutory standard for biosimilarity and adequate performance data for the delivery device or container closure system are provided. For a proposed biosimilar product in a different delivery device or container closure system, the presentation must be shown to be compatible for use with the final formulation of the biological product through appropriate studies, including, for example, extractable/leachable studies and stability studies. Also, for certain design differences in the delivery device or container closure system, performance testing and a human factors study may be needed.
  8. 8. 8 Answer continued: However, a prospective biosimilar applicant will not be able to obtain licensure under section 351(k) for its product when a design difference in the delivery device or container closure system results in: • a clinically meaningful difference between the proposed product and the reference product in terms of safety, purity, and potency; • a different route of administration or dosage form; or • a condition of use for which the reference product has not been previously approved; or otherwise does not meet the standard for biosimilarity. Q. I.4. Can a proposed biosimilar product have a delivery device or container closure system that is different from its reference product?
  9. 9. 9 Answer continued: Additional considerations apply for a proposed interchangeable product. For example, in reviewing an application for a proposed interchangeable product, FDA may consider whether the differences from the reference product significantly alter critical design attributes, product performance, or operating principles, or would require additional instruction to healthcare providers or patients, for patients to be safely alternated or switched between the reference product and one or more interchangeable products without the intervention of the prescribing healthcare provider. Additional performance data about the delivery device may also be necessary. A proposed biosimilar product in a delivery device will be considered a combination product and may, in some instances, require a separate application for the device. Q. I.4. Can a proposed biosimilar product have a delivery device or container closure system that is different from its reference product?
  10. 10. A. I.6. (Proposed Answer): Yes, an applicant is not required to obtain licensure for all presentations for which the reference product is licensed. However, if an applicant seeks licensure for a particular indication or other condition of use for which the reference product is licensed and that indication or condition of use corresponds to a certain presentation of the reference product, the applicant may need to seek licensure for that particular presentation (see also responses to Q. I.4 and Q. I.5). 10 Q. I.6. Can an applicant obtain licensure of a proposed biosimilar product for fewer than all presentations (e.g., strengths or delivery device or container closure systems) for which a reference product is licensed?

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