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FDA Proposes Benefit-Risk Assessment Guidance for New Drug and Biological Products

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In October 2023, the FDA introduced a significant guidance document, “Benefit-risk assessment for new drug and biological products”, for the pharmaceutical industry. This guidance focuses on the assessment of benefit-risk for new drugs and biological products. This comprehensive guideline aims to bring clarity for drug sponsors and stakeholders regarding how the FDA considerations (drug’s benefits, risks, and risk management options) in premarket and post-market regulatory decisions. This guidance pertains to new drug applications (NDAs) under section 505(b) of the Federal Food, Drug, and Cosmetic Act and biologics license applications (BLAs) under section 351(a) of the Public Health Service Act.

Key Elements of the Guideline

This guidance addresses the following key points for Regulatory decisions for approval:

• Labeling considerations (including boxed warnings)
• Post-marketing studies and commitments
• Risk evaluation and mitigation strategies

Note: The guidance document does not cover decisions during the drug development lifecycle, such as those related to first-in-human trials or expanded access applications.

About the Content in Focus

The FDA’s approach to benefit-risk assessment of new drugs and biological products plays a pivotal role in the FDA’s regulatory review for marketing applications. The document provided in-depth details regarding the FDA’s benefit-risk framework and other important considerations.

• The following are the key points for the assessment of benefit-risk assessment of the drug as per the FDA:
  • Therapeutic context of the drug
  • Evidence (submitted)
  • Uncertainties
  • FDA’s regulatory options ( adding contraindications, limitations of use, boxed warnings, etc.)
•  FDA has also provided the benefit-risk framework as follows:

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• It also focused on the role of patient experience data in in FDA’s Benefit-Risk Assessment and how to collect the same information in a structured manner.
• The document has details regarding the structured benefit-risk planning during drug development and the details required for the interaction between the sponsor and the FDA for the benefit-risk assessment.
• Finally, it also focused on the information regarding the additional analyses and the presentation of the risk-benefit consideration in marketing applications.

Industry Impact

The guidance provides valuable insights to the marketing authorization holder on the important key points in line with the FDA’s expectation that should be considered during the development of the benefit-risk assessment profile of a new drug and a biological product.

Conclusion

Benefit-risk assessment is a continuous process that doesn’t conclude with FDA approval. Post-market data sources, periodic reporting, and prompt communication of safety concerns all contribute to ongoing benefit-risk evaluations throughout a drug’s lifecycle. The FDA emphasizes the importance of communicating new information regarding safety concerns that could affect a drug’s benefit-risk profile. This guidance is a significant resource for the pharmaceutical industry, providing a comprehensive framework to assess the benefits and risks of new drugs and biological products.

This blog provides an overview of the FDA’s guidance, shedding light on its implications for the pharmaceutical industry. It emphasizes the critical role of benefit-risk assessment in drug development and post-market evaluation, underscoring the need for continuous monitoring and transparent communication with regulatory authorities.

Benefit-Risk Assessment for New Drug and Biological Products – FDA Guidance can be found here.

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Starting your journey towards meeting with the FDA regulatory requirements? Let Celegence assist you. Reach out to us today to explore the possibilities of partnering with Celegence’s regulatory team. For more information reach out to us at info@celegence.com, contact us online or learn more about our service offering on our services page.

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bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ 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FDA Issues Guidance for Industry on Biosimilar Labeling

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Stay Informed, Stay Prepared

The FDA is charting the course for the future of biosimilars with its recent release. On September 15, 2023, the FDA unveiled its draft guidance document, “Labeling for Biosimilar and Interchangeable Biosimilar Products,” along with a Notice of Availability (NOA). This document is pivotal, as it sets the stage for how biosimilars will be labelled and understood in the United States.

What are Biosimilars?

Biosimilars are biological medical products that are very similar to an original biologic product but made by a different company. They are safe and effective treatments for many illnesses, including chronic skin and bowel diseases, arthritis, kidney conditions, and cancer. Biosimilars can make lifesaving medications more affordable and accessible for patients. A biosimilar is highly similar to a biologic medication already approved by the FDA, called the reference product. Biosimilars have no clinically meaningful differences from the reference product in terms of safety, efficacy, and immunogenicity.

Why Does It Matter?

Biosimilars represent a new frontier in healthcare, offering patients access to biologic treatments that are highly similar to existing FDA-approved reference products. Understanding how to label these products accurately is crucial for manufacturers, healthcare providers, and, most importantly, patients. Here’s what you need to know:

Key Takeaways

• Consistency is Key: The guidance emphasizes that biosimilar and interchangeable biosimilar product labeling should align with the reference product’s labeling. This includes indications, dosing regimens, strengths, dosage forms, and routes of administration. Biosimilar labeling should mirror the reference product, ensuring healthcare providers and patients can easily identify the similarities and differences.
• Clarity is Crucial: The guidance prioritizes clear and concise language in labeling, ensuring healthcare providers and patients easily understand it. Complex terminology is out; plain language is in. Use everyday language to describe product information, avoiding jargon that can confuse readers.
• Structure Matters: The labeling should follow a logical and user-friendly structure with clear headings and subheadings to guide users through the information effectively. Organize the labeling with headings and subheadings that make it easy for readers to locate specific details.
• Highlight Biosimilarity: Biosimilars should have a clear statement in the Highlights section of their labeling, affirming that they are highly similar to the reference product with no clinically meaningful differences in safety, purity, and potency. The biosimilarity statement should be clear and concise, with an associated footnote providing additional supporting information.
• Safety and Efficacy: The labeling should comprehensively cover safety and efficacy information, including adverse reactions, warnings, precautions, and clinical trial data. Include information on observed adverse reactions and postmarketing experiences. Detail the clinical efficacy of the product, drawing on data from clinical trials and relevant studies.

In-Depth Insights

The guidance document is organized into 4 main sections:

1. Introduction: Get a grasp of the document’s purpose and importance in shaping biosimilar labeling.
2. Background: Dive into the world of biosimilars, understanding the regulatory framework and the critical role of accurate labeling.
3. General Principles: Learn the principles behind drafting biosimilar product labeling, from product identification to proprietary names and safety and efficacy information.
4. Specific Recommendations: Discover the nitty-gritty details of what should be included in different sections of biosimilar product labeling.

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The Extended Opportunity

Good news! The FDA has extended the deadline for submitting comments on this game-changing draft guidance to November 17, 2023. Your voice matters in shaping the future of biosimilar labeling.

In the rapidly changing field of biosimilars, it is essential to stay informed and engaged with regulatory guidance. This document provides guidance to manufacturers, healthcare providers, and patients, helping them to make informed decisions about biosimilar treatment.

FDA’s Guidance on Biosimilar Labeling – Conclusion

The Labeling for Biosimilar and Interchangeable Biosimilar Products: Draft Guidance for Industry is a vital resource. It’s not just about labels; it’s about clarity, consistency, and confidence in biosimilar products. Join the conversation, submit your comments, and be a part of shaping the future of biosimilars.

FDA’s guidance on Biosimilar Labeling can be viewed here.

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Celegence has a team of experts who can provide you with reliable and flexible regulatory solutions. For more information reach out to us at info@celegence.com, contact us online or learn more about our service offering on our services page.

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image_id=”17829|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”FDA Finalizes Guidelines on Dose Banding – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” 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FDA Finalizes Guidelines on Dose Banding for Ready-to-Use Containers

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The U.S. Food and Drug Administration (FDA) has recently issued a new guideline titled “Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding” Guidance for Industry” and was recently published in October 2023. The guideline represents the current thinking of the FDA on labeling for dosing based on weight or body surface area (BSA) for ready-to-use containers.

Understanding Dose Banding

Dose banding is a practice where dosing for the drug product is based on weight or BSA, the drug product is available in a range of strengths in ready-to-use containers, and the entire drug content of the ready-to-use container(s) is intended to be administered to a patient.

Purpose of the Guideline

The primary purpose of the FDA guideline is to assist applicants when dosing is based on weight or BSA, and the drug product comes in a range of strengths within ready-to-use containers. The guideline aims to ensure that the entire drug content in these containers is administered to the patient.

FDA Recommendations

The FDA’s guidance on dose banding for ready-to-use containers includes several recommendations:

• Dosage and Administration Section: Display dose banding information and previously approved recommended dose. Include details on selecting the right ready-to-use container(s) based on the patient’s weight or BSA.
• Clinical Pharmacology Section: Provide clinical/scientific information supporting dose banding when applicable. Detail the maximum difference between the previously approved and proposed product’s dose in the Pharmacokinetics subsection.
• Information on doses: Offer information on doses using a range of ready-to-use containers, including the maximum acceptable differences between the recommended dose of the previously approved drug product and the dose based on available strengths of the ready-to-use containers.
• Recommendations for situations when dose falls outside of dose range: Provide recommendations for situations when the dose based on weight or BSA falls outside of the dose range for which the ready-to-use containers are supplied.

Impact of dose banding guidance on drug manufacturers

The FDA’s guidance on dose banding for injectable drug products could have several implications for drug manufacturers:

• Data and Evidence: Manufacturers may need to provide sufficient data and evidence to validate the safety and efficacy of proposed dose banding ranges for their injectable drug products.
• Labeling Updates: They may need to update their labeling to include clear instructions on how to select and administer the appropriate ready-to-use container(s) based on the patient’s weight or BSA, as well as the maximum acceptable differences between the exact weight- or BSA-based dose and the dose based on dose banding.
• Simplification and Reduction: Dose banding could simplify the preparation and administration of their injectable drug products and reduce drug waste and medication errors.

Application of Guidance

The guidance is intended to assist applicants in incorporating dose banding information into the proposed drug labeling in a new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and in a biologics license application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act), or a supplement to one of these approved applications. However, it does not apply to abbreviated new drug applications (ANDAs) or BLAs submitted under section 351(k) of the PHS Act.

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Examples of Dose Banding

There are several examples of drugs that use dose banding. For instance, 5-fluorouracil (5-FU) is given in protocols requiring an IV bolus dose of 600mg/m². Another example is Capecitabine, which is dispensed using dose banding owing to limitations imposed by tablet sizes. The dose calculated for an individual, based on BSA, is modified to a standardized dose to accommodate the tablet strengths available. The National Dose Banding Table Standard 20mg/mL provides examples of drugs such as Cyclophosphamide, Cytarabine (low dose), Dacarbazine, Docetaxel, and Etoposide that use dose banding. Dose banding has been suggested as an alternative approach to precise dosing and can lead to decreased outpatient waiting time and reduced drug waste, medication errors, and preparation time for administration.

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FDA’s Dose Banding Guidance Conclusion

The FDA’s dose banding guidance serves as a valuable resource for drug manufacturers and applicants. By simplifying dosing and administration, reducing errors and waste, and improving patient safety, it represents a significant step forward in drug product labeling. With clear instructions and rigorous data requirements, it aims to ensure that patients receive the right doses based on their weight or BSA, ultimately enhancing safety and efficacy in drug administration.

In conclusion, the FDA’s recent guidance on dose banding in drug labeling is a noteworthy development, with the potential to simplify dosing and enhance patient safety in the realm of injectable drug products. It offers valuable recommendations for drug manufacturers and applicants, paving the way for improved practices in the pharmaceutical industry.

FDA’s final guidelines on Dose Banding can be viewed here.

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