Re: Docket No. FDA-2015-D-4848: Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development   Dear Sir/Madam:   The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance entitled “Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development” (Draft Guidance).   BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.   General Comments BIO is appreciative of FDA’s efforts to provide greater clarity regarding human factors (HF) issues in the context of combination products that are comprised of a drug or biological product and a device, and “to promote the development and timely review of safe and effective combination products.”   Combination products are comprised of any combination of a drug, device or biologic product (e.g., drug-device, biologic-device, drug-biologic, or drug-device-biologic). Each constituent part of a combination product retains its original regulatory status and, therefore, the combination product is subject to the unique regulatory requirements applicable to each of its constituent parts.   Advances in personalized medicine and new drug delivery technologies have led to an ever-increasing number of combination products being co-developed to meet unmet needs. However, the FDA review structure on which Sponsors rely is one that was established at a time when products were being developed individually, which had led to redundancies and inconsistencies in the review of…

Re: Draft Guidance for Industry: Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643 (April 4, 2016))   The Biotechnology Innovation Organization (“BIO”) welcomes the opportunity to submit comments on the Food and Drug Administration’s (“FDA’s”) draft guidance entitled “Labeling for Biosimilar Products” issued on April 4, 2016 (“Draft Guidance”). BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.   Implementation of the Biologics Price Competition and Innovation Act (“BPCIA”) is of significant importance to BIO members, and we greatly appreciate FDA’s issuance of the long-awaited draft guidance on labeling of biological products licensed under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)). BIO is pleased to see the Agency’s recognition that a clear statement of biosimilarity provides essential information to inform the safe prescribing and use of biosimilar biological products. However, the proposed biosimilarity statement fails to convey critical information as to whether or not FDA has made a determination of interchangeability with the reference product. The failure to include such information risks creating confusion among prescribers, payers and other stakeholders regarding whether the biosimilar product has been determined to be interchangeable with the reference product.   Furthermore, we have significant concerns about a fundamental premise of FDA’s draft recommendations and some of the proposals that ostensibly flow from that premise. In finalizing the…

Re: Docket No. FDA-2016-D-0973: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information” (Draft Guidance).  BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products. We find this Draft Guidance to be thorough and well-considered. It takes into account several approaches to utilizing change protocols for postapproval changes. It would be helpful for the Draft Guidance to state that the content requirements should follow the current common technical document (CTD) format. Finally, it will be important that this Guidance is aligned with the final ICH Q12 guideline once complete. To this end, BIO notes that continuity and consistency of terms across various guidances and guidelines will be necessary in order to ensure clarity for both Sponsors and Regulatory Authorities. We provide additional specific, detailed comments to improve the clarity of the Draft Guidance in the following chart. We would be pleased to provide further input or clarification of our comments, as needed.