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    Home > Medical News > Latest Medical News > How can biosypolytic drugs be approved for more allergies? CDE text guide!

    How can biosypolytic drugs be approved for more allergies? CDE text guide!

    • Last Update: 2020-10-15
    • Source: Internet
    • Author: User
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    On August 14th, China's first QutoZhudan anti-biosynthic drug from Fuhong Hanxuan was approved for sale, and all the adaptations approved in China by Hercetin, the original research product.
    same day, the Drug Review Center (CDE) of the State Drug Administration of China publicly solicited the Guiding Principles for the Evaluation of Biosypolytic Drug Similarity and The Technical Guidelines for The Extratrophic Extratroller of Adaptation (Draft for Comments).
    previously, Biotay's Adamo monobial-like drugs (Greli) and Fuhong Han-Han-lytoxi monobial-like drugs (Hanlikang) have been awarded five adaptations in China.
    with the development and evaluation of biosynthic drugs, the evaluation of similarity of such products and the scientific standards of adaptive extraterrence have become the focus areas of concern in the industry.
    is "similarity"? According to the draft opinion, similarity means that there is no clinically significant difference in purity, safety and effectiveity between biosynthics and reference drugs.
    biosypolytic drug similarity evaluation should be based on pharmaceutical, non-clinical, clinical evaluation of the results of the study to determine the overall similarity between the candidate drug and the reference drug.
    opinion draft points out that similarity evaluation should be carried out at different stages of the progressive study of biosynthic drugs, so as to help guide the follow-up targeted comparing studies, and then to evaluate the similarity as a whole.
    The results of the previous study showed that there was a difference between the candidate drug and the reference drug, but the effect of the difference on safety effectiveness was uncertain, and after the follow-up targeted comparative study, no clinical significance was found, the similarity between the candidate drug and the reference drug can be considered.
    is an adaptive extraterrence? According to the draft opinion, the adaptation extraterrestress refers to: within the scope of the reference drug approved adaptation, biosypolytic drugs are approved by direct clinical comparation of the experimental adaptation, through the relevant data and information to scientifically prove and obtain other non-directly studied adaptations. The
    draft notes that the adaptation extraterrestress is based on all the scientific considerations of the available reference and candidate drugs, and that it is important to assess and demonstrate whether there are differences in mechanisms of action, PK, PD, effectiveness, safety and immunogenicity between candidate and reference drugs in the non-directly studied adaptive population.
    Usually, extrapolation needs to meet the following conditions: 1) sensitive clinical trial models have been used to detect differences between reference and candidate drugs, 2) clinically relevant mechanisms of effect and/or associated subjects are the same, 3) the safety and immunogenicity of biosypolytic drugs have been adequately characterized, and the inferred adaptation has no special or additional safety issues.
    Case Study Adami (Shumeile α) is approved worldwide for the treatment of multiple adaptations, including moderate to severe mandatory spina bifida, rheumatoid arthritis, plaque-type psoriasis, α psoriasis, psoriasis, psoriasis, and psoriasis. Pathological mechanisms of pathogenic arthritis, early idiopathic arthritis, and staphylococcitis are abnormally high expressions of TNF-α, and the main mechanism of action of Adamo monoantigens on these adaptations is mainly binding and neutraling soluble tumor necrosis factor-α (sTNF-α).
    And in moderate to severe crohn's disease and ulcerative colitis, TNF-α as the main anti-inflammatory factor is an important regulatory factor in the pathogenesis, adamo single resistance to such inflammatory bowel disease mechanism in addition to binding sTNF, but also by binding trans-membrane tumor necrosis factor - α (tmTNF-α) to play a role. the
    opinion notes that when adaptive extratrophics are extratrophic, it is important to assess whether sensitive models are used in PK, PD, and clinical comparative studies to support clinical similarity evaluation, and to focus on whether studies such as biofunsic activity, such as sT, have been conducted on known or potential mechanisms of action of adamo monoantigens in different adaptations. NF alpha binding activity (ELISA), sTNF alpha binding dynamics (SPR method), TNF alpha neutralization activity, apoptosis inhibition, etc., because monoclonal antibodies have multiple biological activities, should be based on the degree of relevance to clinical effects to determine the weight of similarity, and set standards.
    For example, when extraterred from psoriasis, rheumatoid spina bifida, or rheumatoid arthritis to inflammatory bowel disease, the similarity of indicators based on the biological activity or immunological characteristics of the Fc-end mechanism of action should be fully evaluated, or consideration may be given to establishing a cellular model for in-body inflammatory enteropathy IBD (e.g., inhibition of HCT-116 apoptosis and IL-8 release).
    According to the clinical trial data of the original drug, among the approved adaptations, Adamo mono-anti-treatment plaque psoriasis was the most effective, with the greatest difference in efficacy at the main end of the treatment period compared to placebo, at 45-61%, and in other adaptations such as mandatory spinalitis, the difference in efficacy was 18-37%; The difference was 18-35%, in adult staphylococcitis was 16-24%, in adult Crohn's disease-induced remission was 14-24%, the effect difference was maintained at 23-26%, and in adult ulcerative colitis-induced remission was 7.2-9.3%, and the efficacy difference relative to placebo was decreasing.
    Where psoriasis is a separate drug, does not require a combination of immunosuppressants, and the immunogenicity of psoriasis patients is 8.4%, similar to the immunogenicity of patients with mandatory spinalitis (8.6%) and rheumatoid arthritis (12.4%), so in these adaptations, moderate to severe plaque psoriasis can be used as a more sensitive group to assess the effectiveness, safety and immunogenic similarity of candidates and reference drugs.
    In addition, taking into account the clear mechanism of action of adamo monoantigen in mandatory spinalitis adaptation, stable therapeutic dose, clinical use does not need to combine immunosuppressant drugs, can also be used as one of the sensitive adaptors to assess the difference between candidate drugs and reference drugs.
    Combining the above multi-factor analysis, based on the purpose of similarity evaluation and adaptation extraterrence, when formulating the overall clinical research strategy of Adamo monoantigen-like drugs, we should select healthy populations for PK-to-population studies as far as possible, and select patient-sensitive models related to adaptive populations for clinical-to-clinical studies.
    If the healthy population is not selected for PK matching, it is recommended to select different sensitive models for PK and clinical studies, wherein clinical reference studies should consider selecting the most sensitive models to conduct research to fully assess the clinical similarity between candidate drugs and reference drugs.
    : a notice on public consultation on the Technical Guidelines for Biosypole Drug Similarity Evaluation and Adaptation Extratroller (Draft for Comments). Retrieved Aug 14,2020, from s2. The first domestic curt bead single anti - Hanqu you ® approved for listing. Retrieved Aug 14, 2020, from s3® (Adamo monoantigen injection) was approved for the fifth adaptive disorder. Retrieved Aug 11, 2020, from the gospel of patients with blood tumors, China's first biosynthic drug Hanlikang® two new allergens have been approved. Retrieved Jul 14, 2020, from.
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