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Boosting the use of real-world evidence (RWE) in decision making in Canada—that is the objective of an industry task force (ITF) convened by Canada's Drug Agency (CDA) (tinyurl.com/5f3mp8tc). It has participation from 10 biopharmaceutical companies, one Health Canada representative, and five CDA staff members. According to CDA, “the ITF represents a milestone as a first-of-its-kind, time-limited working collaboration and deliberation on sharing of industry-sponsored RWE with Health Canada and our organization.” The objective was “to provide formal advice to the PMDE [Post-Market Drug Evaluation] program on questions related to operationalizing access to and use of industry-sponsored RWE,” with a goal of incorporating some changes into the current PMDE process before the end of 2024. Manufacturers have expressed willingness to generate post-marketing RWE with payers, CDA and Health Canada, but the process would need to be patient-focused and promote appropriate access to pharmaceuticals. It would be difficult for manufacturers to engage in any process where PMDE customers cannot be transparent about the objectives and ultimate use of the evidence. Reimbursement Reviews could be a good starting point to collecting RWD for future decision-making purposes. Companies are interested in being involved throughout the PMDE query process to reduce barriers to participation. Transparency was one of the key issues addressed. Manufacturers indicated that they would share evidence only if there is an adequate level of transparency around a research question and protocols used for PMDE queries, as well as clarity on the intended use of evidence and outcomes. In terms of actions required, CDA indicated that it “should provide manufacturers with multiple-use cases to describe hypothetical or real questions and responses to requests for evidence.” The agency should also “consider establishing optional upstream processes that involve exchanges between our organization, payers, and manufacturers as part of establishing an evidence-generation plan.” There is a need to “consider a process that involves manufacturers and alignment between all impacted groups when analyzing industry-sponsored evidence” and to “consider revised timelines and feasibilities depending on the types of RWD sources (e.g., PSPs [patient support programs] vs. chart reviews) required.” Given the nature of the PMDE program, CDA believes the process should be refined regularly: “We should explore mechanisms to better anticipate future RWE queries that involve manufacturers, payers, and our organization at earlier stages of the drug review life cycle. Alternatively, this could happen after a recommendation is issued.” Both CDA and the industry are open to a pilot project on joint RWE generation. #Canada #RWE #CDA

Pharmaceutical News Update | Weekly Highlights (May 20-26) Regulatory Announcements CDE: Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2023) Notification from of NMPA and Health Commission on Strengthening the Management of Dextromethorphan and Other Drugs CDE: Notification on publicly soliciting opinions on the Submission Guidelines and Implementation Framework of the Pilot Work Plan for Patient-Centered Drug Development for Rare Diseases (“Caring Plan”) Company News Update 1. Haisco: Crisugabalin Besylate Capsules (Trade Name: Simeining) has been approved for marketing. 2. Shanghai Yanan Pharma: Marketing application for Loxoprofen Sodium Cataplasms has been accepted.   3. Hubei Biocause Pharma: Torasemide Tablets have passed generic drug consistency evaluation. 4. Shenzhen Salubris: Application for production of Allisartan Mexate and Amlodipine Tablets has been approved. 5. Hefei Chengzhi Biopharma: Application for production of Loxoprofen Sodium Oral Solution is under review. 6. Lunan Better Pharma: Supplementary application for consistency evaluation of Acipimox Capsules has been approved. 7. Chengdu Brilliant Pharma: Two generic drugs have been approved for production on the same day and deemed to have passed consistency evaluation. 8. CR DOUBLE-CRANE Limin Pharma (Jinan): Phlorlglucinol for Injection has been approved for production and deemed to have passed consistency evaluation. 9. Chengdu Easton Biopharma: Beraprost Sodium Tablets has been approved for marketing. 10. Jiangsu Wanbang Biopharma: Marketing application for Baricitinib Tablets has been submitted. 11. Livzon Pharmaceutical Group: Rabeprazole SodiumEnteric-coated Tablets has been approved for marketing. 12. Hengrui Pharma: TROP-2 (antibody-drug-conjugate, ADC) SHR-A1921 for injection was proposed to be included in the public list of breakthrough therapeutic varieties by the Drug Evaluation Center of NMPA. 13. Yunhe Pharma (Tianjin): Phase I/IIa clinical trial of INR101 Injection was completed with the enrollment and dosing of the first healthy subject at Beijing Friendship Hospital of Capital Medical University. 14. FOSUN PHARMA: The registration application for FCN-159 Tablets has been recently accepted by NMPA. 15. Novo Nordisk China: The European Commission (EC) has granted marketing authorization for Awiqli (insulin icodec). 16. Beta Pharma: EGFR inhibitor Rezivertinib Mesylate Capsules has been approved for marketing. 17. Akeso Biopharma: Ivonescimab Injection (Trade Name: Yidafan) has been approved for marketing. 18. Yantai Lannacheng Biotechnology Co., Ltd.: Notification of Approval for Clinical Trials from NMPA for 177Lu-LNC1010 Injection has been received.

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic 21st June, 2024 Today, the U.S. Food and Drug Administration published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). The OPOE list includes approved new drug applications (NDAs) for drug products that are not protected by patents or exclusivities at the time of each update, and for which FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA. FDA maintains the OPOE list to improve transparency and encourage the development and submission of applications under an abbreviated approval pathway for drugs with limited competition. We update this list every six months to ensure continued transparency regarding drug products where increased competition has the potential to provide significant benefit to patients. This list is also useful within FDA as we develop additional product-specific guidances and other resources to assist prospective ANDA applicants. For more information on our efforts to bring more drug competition to the market, visit the Drug Competition Action Plan (DCAP) web page. Call for Collaboration with U.S. Pharmacopeia (USP) In support of DCAP and the USP Generics Access Plan, USP has prioritized the development of monographs associated with drug products on the OPOE list, identifying opportunities where public quality standards can help increase access to medicines with great potential benefit to public health. To date, USP has developed 19 monographs, official in the USP-NF, associated with 18 drug products on the OPOE list. In spring 2024, USP proposed a new monograph associated with a drug product on the OPOE list in Pharmacopeial Forum: Triptorelin Pamoate, an active ingredient used in the treatment of prostate cancer. USP is currently seeking public comments on the Triptorelin Pamoate monograph until July 31, 2024. Additionally, USP has posted an emerging standard – a potential standard not yet in the formal development process – for Clindamycin Phosphate Injection, an antibiotic. USP is seeking stakeholder engagement, discussion, and contribution for these standards. Learn more about USP’s Generics Access Plan, how you can help advance our shared priorities, and how monograph development efforts can facilitate greater patient access to quality medicines at USP’s Call for Collaboration.

Real World Evidence in Decision Making- Patient Focused Process and Transparent Objectives:  Earlier engagement to gather a wider range of evidence, reduce delays in accessing evidence, and identify potential gaps in evidence during the drug review process to prepare for future post-market evidence needs!

𝗗𝗿𝗮𝗳𝘁 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗨𝘀𝗲-𝗥𝗲𝗹𝗮𝘁𝗲𝗱 𝗥𝗶𝘀𝗸 𝗔𝗻𝗮𝗹𝘆𝘀𝗶𝘀 𝗳𝗼𝗿 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀 In a significant move aimed at enhancing the safety and effectiveness of combination products, the U.S. Food and Drug Administration (FDA) has recently released a draft guidance document focusing on the use-related risk analysis (URRA) for these complex products. This draft guidance represents a crucial step in refining regulatory practices and ensuring that combination products—those that combine drugs, devices, and/or biologics—meet high safety and efficacy standards. URRAs are instrumental in how use-related hazards can be identified and mitigated through design risk analysis, and are an integral part of the process for an investigational new drug application (IND), a new drug application (NDA), or a biologics license application (BLA). While human factors (HF) are not within the scope of this guidance, it is urged that manufacturers take into account how URRAs can incorporate HF at products’ early-stage development and throughout their lifecycle. Key aspects of the draft guidance include: - Definition of Use-Related Risks: The FDA defines use-related risks as those that stem from how a product is used by patients, caregivers, or healthcare professionals. These risks are distinct from inherent risks associated with the product’s components and their intended effects. - Analytical Framework for Risk Assessment: The guidance outlines a framework for conducting use-related risk analyses. It emphasizes the need for a systematic approach that includes identifying potential use-related hazards, assessing their severity and likelihood, and implementing strategies to mitigate identified risks. - Importance of Human Factors Engineering (HFE): The draft document highlights the role of Human Factors Engineering in the development of combination products. HFE principles are essential for designing products that are intuitive and user-friendly, thereby reducing the risk of use errors. - Methods for Risk Evaluation: The guidance describes various methods for evaluating use-related risks, including formative and summative human factors studies. It encourages manufacturers to engage in iterative testing and refinement processes to address potential issues before the product reaches the market. - Documentation and Submission Requirements: The draft guidance provides recommendations on how to document the results of the use-related risk analysis and integrate this information into regulatory submissions. Clear and thorough documentation is crucial for demonstrating that risks have been identified and addressed. The FDA is seeking feedback from stakeholders until September 9, 2024. https://lnkd.in/gMFP-xkM For more industry news and insights, visit our website: https://lnkd.in/eGrnpRdv

Biogeneric Drugs Market Insights by Growth, Emerging Trends and Forecast by 2024-2033 https://lnkd.in/dJqgDUYn The Biogeneric Drugs Market refers to the segment of the pharmaceutical industry involved in the development, manufacturing, and commercialization of biogeneric drugs, also known as biosimilars or follow-on biologics. Biogeneric drugs are highly similar versions of approved biologic drugs, manufactured after the expiration of patents and exclusivity rights held by the originator biopharmaceutical companies. Key components of the Biogeneric Drugs Market include: Biologic Drugs: Biologic drugs are complex therapeutic agents derived from living organisms, such as proteins, antibodies, hormones, enzymes, and nucleic acids. These drugs are produced through biotechnological processes involving recombinant DNA technology, cell culture systems, and protein purification techniques. Biologic drugs are used to treat various diseases and medical conditions, including cancer, autoimmune disorders, inflammatory diseases, and infectious diseases. Biosimilar Development: Biosimilar development involves the characterization, comparison, and clinical evaluation of biogeneric drugs to demonstrate similarity in quality, safety, efficacy, and immunogenicity to the reference biologic drug. Biosimilar manufacturers conduct extensive analytical studies, preclinical testing, and clinical trials to establish biosimilarity and obtain regulatory approval from health authorities, such as the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe. Regulatory Pathways: Regulatory agencies have established specific pathways for the approval and regulation of biosimilar drugs, which differ from those for small-molecule generic drugs. These pathways require comprehensive comparability studies, including analytical characterization, pharmacokinetic/pharmacodynamic studies, and clinical trials to demonstrate biosimilarity and interchangeability with the reference biologic drug. Biosimilar approval pathways aim to ensure patient safety, promote competition, and facilitate access to affordable biologic therapies. Market Access and Adoption: Market access and adoption of biogeneric drugs depend on various factors, including regulatory approval, pricing and reimbursement policies, healthcare provider acceptance, patient preferences, and competition from originator biologic drugs. Successful market entry requires biosimilar manufacturers to navigate complex regulatory processes, establish partnerships with distributors and healthcare providers, and educate stakeholders about the benefits and value proposition of biosimilars. Factors driving the Biogeneric Drugs Market include: Patent Expiry of Biologic Drugs: The expiration of patents and exclusivity rights for originator biologic drugs creates opportunities for biosimilar manufacturers to enter the market and offer l

Biogeneric Drugs Market Insights by Growth, Emerging Trends and Forecast by 2024-2033 https://lnkd.in/dJqgDUYn The Biogeneric Drugs Market refers to the segment of the pharmaceutical industry involved in the development, manufacturing, and commercialization of biogeneric drugs, also known as biosimilars or follow-on biologics. Biogeneric drugs are highly similar versions of approved biologic drugs, manufactured after the expiration of patents and exclusivity rights held by the originator biopharmaceutical companies. Key components of the Biogeneric Drugs Market include: Biologic Drugs: Biologic drugs are complex therapeutic agents derived from living organisms, such as proteins, antibodies, hormones, enzymes, and nucleic acids. These drugs are produced through biotechnological processes involving recombinant DNA technology, cell culture systems, and protein purification techniques. Biologic drugs are used to treat various diseases and medical conditions, including cancer, autoimmune disorders, inflammatory diseases, and infectious diseases. Biosimilar Development: Biosimilar development involves the characterization, comparison, and clinical evaluation of biogeneric drugs to demonstrate similarity in quality, safety, efficacy, and immunogenicity to the reference biologic drug. Biosimilar manufacturers conduct extensive analytical studies, preclinical testing, and clinical trials to establish biosimilarity and obtain regulatory approval from health authorities, such as the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe. Regulatory Pathways: Regulatory agencies have established specific pathways for the approval and regulation of biosimilar drugs, which differ from those for small-molecule generic drugs. These pathways require comprehensive comparability studies, including analytical characterization, pharmacokinetic/pharmacodynamic studies, and clinical trials to demonstrate biosimilarity and interchangeability with the reference biologic drug. Biosimilar approval pathways aim to ensure patient safety, promote competition, and facilitate access to affordable biologic therapies. Market Access and Adoption: Market access and adoption of biogeneric drugs depend on various factors, including regulatory approval, pricing and reimbursement policies, healthcare provider acceptance, patient preferences, and competition from originator biologic drugs. Successful market entry requires biosimilar manufacturers to navigate complex regulatory processes, establish partnerships with distributors and healthcare providers, and educate stakeholders about the benefits and value proposition of biosimilars. Factors driving the Biogeneric Drugs Market include: Patent Expiry of Biologic Drugs: The expiration of patents and exclusivity rights for originator biologic drugs creates opportunities for biosimilar manufacturers to enter the market and offer l

Biogeneric Drugs Market Insights by Growth, Emerging Trends and Forecast by 2024-2033 https://lnkd.in/dJqgDUYn The Biogeneric Drugs Market refers to the segment of the pharmaceutical industry involved in the development, manufacturing, and commercialization of biogeneric drugs, also known as biosimilars or follow-on biologics. Biogeneric drugs are highly similar versions of approved biologic drugs, manufactured after the expiration of patents and exclusivity rights held by the originator biopharmaceutical companies. Key components of the Biogeneric Drugs Market include: Biologic Drugs: Biologic drugs are complex therapeutic agents derived from living organisms, such as proteins, antibodies, hormones, enzymes, and nucleic acids. These drugs are produced through biotechnological processes involving recombinant DNA technology, cell culture systems, and protein purification techniques. Biologic drugs are used to treat various diseases and medical conditions, including cancer, autoimmune disorders, inflammatory diseases, and infectious diseases. Biosimilar Development: Biosimilar development involves the characterization, comparison, and clinical evaluation of biogeneric drugs to demonstrate similarity in quality, safety, efficacy, and immunogenicity to the reference biologic drug. Biosimilar manufacturers conduct extensive analytical studies, preclinical testing, and clinical trials to establish biosimilarity and obtain regulatory approval from health authorities, such as the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe. Regulatory Pathways: Regulatory agencies have established specific pathways for the approval and regulation of biosimilar drugs, which differ from those for small-molecule generic drugs. These pathways require comprehensive comparability studies, including analytical characterization, pharmacokinetic/pharmacodynamic studies, and clinical trials to demonstrate biosimilarity and interchangeability with the reference biologic drug. Biosimilar approval pathways aim to ensure patient safety, promote competition, and facilitate access to affordable biologic therapies. Market Access and Adoption: Market access and adoption of biogeneric drugs depend on various factors, including regulatory approval, pricing and reimbursement policies, healthcare provider acceptance, patient preferences, and competition from originator biologic drugs. Successful market entry requires biosimilar manufacturers to navigate complex regulatory processes, establish partnerships with distributors and healthcare providers, and educate stakeholders about the benefits and value proposition of biosimilars. Factors driving the Biogeneric Drugs Market include: Patent Expiry of Biologic Drugs: The expiration of patents and exclusivity rights for originator biologic drugs creates opportunities for biosimilar manufacturers to enter the market and offer l

greetings of the day to everyone, 📌Purple book 📄The Purple Book is a compendium of FDA-approved biological products and their bio- similar and interchangeable products. PURPOSE : 1. To assist users, understand if a biological product has been approved by FDA under the PHS Act with a reference product (already approved biological product) . 2. To help identify if there is any exclusivity for a given reference product. Two Lists Of Biologics. 📌The first list includes biologics approved by the FDA’s Center for Drug Evaluation and Research (CDER) . 📌 The second list includes biologics approved by the Center for Bio-logic Evaluation and Research (CBER). The book also includes the following information about the biologics: ❖ BLA Number ❖ Non-Proprietary Product Names ❖ Proprietary Product Names ❖ Date the Product was approved in the Market ❖ Date of the first Licensure ❖ Whether the Product is Bio-similar or Interchangeable ❖ Reference Product with an Expiry Date ❖ Whether the Product is withdrawn from the Market 📌Orange Book 📄It is the publication of “Approved Drug Products with Therapeutic Equivalence Evaluations” by the Food and Drug Administration. It is prepared by The Orange Book Staff, Center for Drug Evaluation and Research. 📄It identified drug products on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetics Act. 📄Drugs marketed only on the basis of safety or pre-1938 drugs. The list is independent of any current regulatory action against a drug product. 📄The FDA does not recommend substituting drugs that have not been determined to be bioequivalent. Drugs that are not listed as bioequivalent should not be substituted for each other. 🔎Objectives 📌To allow review of patterns of access and usage. 📌To allow discovery of use of unusual privileges 📌 To allow discovery of repeated attempts to bypass protections 📌 To serve as a deterrent by its existence 📌To supply an additional form of user assurance Content and Exclusion ❖ Approved OTC drug products for those which are not marketed ❖ Approved prescription drug with therapeutic equivalence evaluations ❖ Drug products with Biologics Evaluation and Research ❖ List of approved products that have been discontinued from the market. 🔎Therapeutic Equivalence-Related Terms 🔎 Statistical Criteria for Bioequivalence 🔎Reference Listed Drug 🔎General Policies and Legal Status 🔎Practitioner/User Responsibilities 🔎Therapeutic Equivalence Evaluations Codes 🔎Description of Special Situations 🔎Therapeutic Equivalence Code Change for a Drug Entity. 🔎Discontinued Section 🔎Key Sections for Using the Drug Product Lists 🔎Drug Product Illustration 🔎Therapeutic Equivalence Evaluations Illustration. #regulatoryaffairs #purplebook #FDA #orangebook Amaan Ansari

CDSCO releases updated version of guidance document for biologicals The Central Drugs Standard Control Organisation (CDSCO) has issued an updated version of the Guidance for Industry for Biologicals after 16 years from the introduction of the previous version, in tune with the regulations and online application processes introduced in recent times. The new document includes guidance for submission of clinical trial applications for evaluating safety and efficacy, requirements for permission for new drugs approval, and guidance for preparation of the quality information for drug submission for new drug approval on biotechnological or biological products. The CDSCO had published the Guidance for Industry (Biologicals) version 1.1 in the year 2008, which was prepared in line with the international guidelines and in accordance with the Drugs and Cosmetics Rules, 1945 and Drugs and Cosmetics Act, 1940. Now, the Version 1.2 is updated to align with New Drugs and Clinical Trials Rules, 2019 and Sugam application process after consultation with the stakeholders and it is published after considering the public suggestions, comments or objections, said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) while introducing the latest version. "This Guidance has been developed in conformity with New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetics Act 1940. The clinical trial sponsor is required to submit an application (Form CT-04) for the purpose of conducting clinical trials in India and submit documents as per New Drugs and Clinical Trials Rules, 2019 there in. The sponsor is also responsible for implementing and maintaining Quality Assurance system to ensure that the clinical trial is conducted and data generated, documented and reported in compliance with the protocol and GCP Guidelines issued by CDSCO as well as all applicable statutory provisions of New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetics Act, 1940. The manufacturer or sponsor has to submit an application in Form CT-04 for permission of clinical trial under the provisions of New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetic Act, 1940. The requirements in respect of chemistry and pharmaceutical information have been elaborated for biologicals in the document while requirement for conduction of clinical trial and other requirements remains the same as per New Drugs and Clinical Trials Rules, 2019. Though the nomenclature of the sections mentioned in the guidance is specific to India, the content is aligned with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, it added. The manufacturer or sponsor shall submit the application in Form CT-04 (online) through SUGAM or the recently launched National Single Window System (NSWS) portal. Whenever new rules are published, the new Rules will prevail over this guidance, says the guidance document.