FDA issued the bio generic declaration, the good news of diabetes is coming!

Today, the FDA released a statement on improving the development efficiency of bio generic drugs and interchangeable insulin products, which is to help more diabetics get better treatment methods, according to the pharmaceutical intelligence news reporter The statement also explained the draft guidance on clinical immunogenicity considerations for insulin products that are similar or interchangeable Access to affordable insulin could be a life and death issue for people with diabetes, the statement said If not treated properly, diabetes can lead to serious and even life-threatening complications, including heart disease, organ failure and blindness Continuous and lifelong access to insulin is essential for patients' survival and quality of life However, FDA is aware of the high cost of insulin, which makes many patients can not get good treatment, which is also a problem that FDA attaches great importance to To solve this problem, FDA will continue to improve the market competitiveness of insulin products, which may reduce the cost of patients and payers, and increase access and product selection This includes promoting the development of safe and effective insulin products for the treatment of type I and type II diabetes, including products that are biologically similar to or interchangeable with approved insulin products In order to inform product developers who intend to apply for FDA approval of insulin products that are biologically similar or interchangeable with insulin products that have been approved, the FDA today released a draft of guidelines for pharmaceutical companies, "precautions for clinical immunogenicity of biologically similar or interchangeable insulin products." The purpose of the draft is to help guide effective product development by clarifying what data and information may or may not be needed to prove the biological similarity or interchangeability of pancreatic islet application products as required by the draft The draft reflects FDA's decades of experience in insulin products, which, along with its extensive clinical application, contribute to a strong scientific understanding of these products The draft also reflects the consideration of stakeholder feedback at FDA's may 019 public hearing, in which stakeholders were invited to provide comments on the development of bio generic drugs and interchangeable insulin products It is worth noting that the FDA proposed in the draft that in some cases, the approval of some applied biosimilars and interchangeable insulin products does not require a comparative clinical immunogenicity study In general, immunogenicity studies investigate the presence and clinical impact of immune responses to therapeutic proteins, thus affecting the efficacy and safety of treatment In the circumstances described in the draft, FDA generally expects that the immunogenicity of certain biosimilars and interchangeable insulin products will have the least risk of clinical impact Therefore, while the use of biosimilars and interchangeable insulin products is expected to include an immunogenicity assessment, the assessment may include a scientific rationale for why comparative clinical studies to assess immunogenicity are not required for this particular insulin product The proposals outlined in the draft reflect a broad and multifaceted assessment of scientific considerations, and may lead to more effective development plans that could eventually bring biosimilars or interchangeable insulin products to market more quickly Applications for biosimilars or interchangeable insulin products need to meet strict legal standards Applicants need to submit data and information sufficient to prove the biosimilars or interchangeability, including clinical pharmacology research, chemical composition, manufacturing and other information, as well as comprehensive and stable comparative analysis and evaluation In order to solve the uncertainty of immunogenicity, a comparative clinical immunogenicity study may still be needed for some insulin products with biological similarity or interchangeability For example, if there are differences in some impurities or dosage forms, a comparative study of clinical immunogenicity may be needed, but it will be a case scientific determination in the context of individual application Currently, FDA is in a transitional period before March 23, 2020, in order to establish a solid regulatory basis for the review and approval of biological analogues and interchangeable insulin products From March 23, 2020, the approved new drug application for biological products (NDAs) will obtain the biological product license (Blas) as required by law After obtaining Blas for biological products (such as insulin products), applicants applying for approval of bio generic or interchangeable products can use the product as a "reference product" Reference products refer to the biological products that have been approved by FDA and compared with the biological imitations or interchangeable products Therefore, the transformation of insulin products from approved NDAs to Blas will make these products face potential competition of biological similarity and interchangeability Approved biosimilars and interchangeable insulin products are expected to increase patients' access to insulin products and reduce the cost of insulin products The purpose of the draft is to improve the efficiency of the development and approval process of biosimilarity and interchangeable products, and to provide scientific and management guidance for the development of biosimilarity products to the maximum extent It is also a key objective of the FDA's biosimilars action plan FDA will also continue to study to improve patients' access to the drugs they need Access to affordable insulin can be a matter of life and death for Americans with diabetes If not appropriately treated, diabetes can lead to series and life threading complications, including heart disease, Morgan failure and blindness And consistent, lifelong access to insulin is imperative to patient survival and quality of life However, we are aware that the high cost of insulin raises serious concerns about the ability of many patients to access insulin products This is an issue the FDA takes very seriously; therefore, today we are announcing new draft guidance that is intended to help facilitate the development of, and improve patient access to, life-saving insulin products The FDA is committed to continuing our efforts to help increase market competition among insulin products, which may potentially lower costs for patients and payors and increase access and product choice This includes facilitating the development of safe and effective insulin products for the treatment of patients with Type 1 and Type 2 diabetes, including products that are biosimilar to, or interchangeable with, an approved insulin product To inform product developers who intend to seek the FDA’s approval of proposed insulin products that are biosimilar to, or interchangeable with, an approved insulin product, the FDA today issued a draft guidance for industry, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” This draft guidance is intended to help guide efficient product development by clarifying what data and information may – or may not – be needed to support a demonstration of biosimilarity or interchangeability for a proposed insulin product, as defined in the draft guidance The draft guidance reflects, among other things, the FDA’s decades of experience with insulin products which, along with wide clinical use, has contributed to a robust scientific understanding of these products The draft guidance also reflects consideration of stakeholder feedback provided at the FDA’s May 2019 public hearing on this topic at which stakeholders were invited to provide input on developing biosimilar and interchangeable insulin products Significantly, the FDA recommends in the draft guidance that, under certain circumstances, a comparative clinical immunogenicity study would not be necessary for approval of certain proposed biosimilar and interchangeable insulin products In general, immunogenicity studies investigate the presence of an immune response to the therapeutic protein and its clinical impact, which can influence whether the therapy will work well and be safe In the circumstances described in the draft guidance, the FDA generally expects the risk of clinical impact from immunogenicity to be minimal for certain proposed biosimilar and interchangeable insulin products As such, while applications for biosimilar and interchangeable insulin products would be expected to include an immunogenicity assessment, that assessment could include a scientific justification of why a comparative clinical study to assess immunogenicity is not necessary for that particular proposed insulin product The recommendations described in the draft guidance, which reflects extensive multidisciplinary evaluation of scientific considerations, may result in a more efficient development program that could ultimately bring biosimilar or interchangeable insulin products to the market more quickly Applications for proposed biosimilar or interchangeable insulin products need to meet strict statutory standards, and applicants will need to submit data and information sufficient to demonstrate biosimilarity or interchangeability, including, among other things, a comparative clinical pharmacology study, adequate chemistry, manufacturing and controls information, and a comprehensive and robust comparative analytical assessment For some proposed biosimilar or interchangeable insulin products, a comparative clinical immunogenicity study may still be needed to address residual uncertainty regarding immunogenicity For example, a comparative clinical immunogenicity study may be needed if there are differences in certain impurities or novel excipients, but that would be a case-by-case scientific determination in the context of individual applications On March 23, 2020, approved New Drug Applications (NDAs) for biological products will be deemed to be licenses for the biological products (i.e., approved Biologics License Applications (BLAs)) under section 351 of the Public Health Service Act After an approved NDA for a biological product (such as an insulin product) is deemed to be an approved BLA, the product can be used as a “reference product” by an applicant seeking approval of a proposed biosimilar or interchangeable product A reference product is the biological product, already approved by the FDA, against which a proposed biosimilar or interchangeable product is compared This will enable, for the first time, submission of applications for products that are proposed as biosimilar to, or interchangeable with, the transition products As such, the transition of insulin products from approved NDAs to deemed BLAs will open up those products to potential biosimilar and interchangeable competition The availability of approved biosimilar and interchangeable insulin products is expected to increase access and reduce costs of insulin products, which millions of Americans take each day to maintain stable blood glucose The FDA is working now, in advance of the March 23