Pub Date : 2022-09-30DOI: 10.3390/biologics2040017
L. Puig, K. Shams, F. Furlan, Cristofer Salvati, Elisa Romero, J. Fan, L. Iversen
SDZ-ADL is a biosimilar of reference adalimumab. Here, the safety and effectiveness data of SDZ-ADL from the British Association of Dermatologists Biologic and Immuno-modulators Register (BADBIR) are reported. In the safety set, data of SDZ-ADL were compared with conventional systemics data. In the effectiveness set, the effectiveness and quality-of-life of patients treated with SDZ-ADL as a first-time biologic, or who switched from a previous biologic to SDZ-ADL, were assessed using the Psoriasis Activity Severity Index (PASI) and Dermatology Life Quality Index (DLQI), respectively. A total of 565 (incidence rate (IR) per 1000 person-years 29.1, 95% CI 26.8–31.6) serious infections and 48 (IR 2.5, 95% CI 1.8–3.3) myocardial infarction events were reported in the conventional systemics cohort compared with four (IR 31.5, 95% CI 8.6–80.7) and one (IR 7.9, 95% CI 0.2–43.9) in the biologic cohort, respectively. One patient (0.7% (1/136)) reported injection-site pain in the biologic cohort. At 12 months, PASI ≤ 2 was achieved in 84.6% (11/13) and 76.9% (10/13) and DLQI 0/1 was achieved in 70% (7/10) and 75% (3/4) of patients in the biologic-naïve and biologic-switch cohorts, respectively. After one year of therapy, 82.7% (110/133) patients remained on SDZ-ADL. SDZ-ADL was well-tolerated and effective in patients with psoriasis.
{"title":"Real-World Effectiveness and Safety of SDZ-ADL (Adalimumab Biosimilar) in Patients with Psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR)","authors":"L. Puig, K. Shams, F. Furlan, Cristofer Salvati, Elisa Romero, J. Fan, L. Iversen","doi":"10.3390/biologics2040017","DOIUrl":"https://doi.org/10.3390/biologics2040017","url":null,"abstract":"SDZ-ADL is a biosimilar of reference adalimumab. Here, the safety and effectiveness data of SDZ-ADL from the British Association of Dermatologists Biologic and Immuno-modulators Register (BADBIR) are reported. In the safety set, data of SDZ-ADL were compared with conventional systemics data. In the effectiveness set, the effectiveness and quality-of-life of patients treated with SDZ-ADL as a first-time biologic, or who switched from a previous biologic to SDZ-ADL, were assessed using the Psoriasis Activity Severity Index (PASI) and Dermatology Life Quality Index (DLQI), respectively. A total of 565 (incidence rate (IR) per 1000 person-years 29.1, 95% CI 26.8–31.6) serious infections and 48 (IR 2.5, 95% CI 1.8–3.3) myocardial infarction events were reported in the conventional systemics cohort compared with four (IR 31.5, 95% CI 8.6–80.7) and one (IR 7.9, 95% CI 0.2–43.9) in the biologic cohort, respectively. One patient (0.7% (1/136)) reported injection-site pain in the biologic cohort. At 12 months, PASI ≤ 2 was achieved in 84.6% (11/13) and 76.9% (10/13) and DLQI 0/1 was achieved in 70% (7/10) and 75% (3/4) of patients in the biologic-naïve and biologic-switch cohorts, respectively. After one year of therapy, 82.7% (110/133) patients remained on SDZ-ADL. SDZ-ADL was well-tolerated and effective in patients with psoriasis.","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48511499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-08-31DOI: 10.3390/biologics2030015
Jaqueline C. Stone, Pisirai Ndarukwa, D. Scheim, B. Dancis, J. Dancis, Martin G. Gill, Colleen Aldous
The emergence of COVID-19 in March 2020 challenged Zimbabwe to respond with limited medical facilities and therapeutic options. Based on early clinical indications of efficacy for the macrocyclic lactone, Ivermectin (IVM), against COVID-19, IVM-based combination treatments were deployed to treat it. Oxygen saturation (SpO2) data were retrospectively analyzed for 34 severe, hypoxic COVID-19 patients all on room air (without supplemental oxygen). The patients, median age 56.5, were treated at clinics or at home between August 2020 and May 2021. All but three of these 34 patients had significantly increased SpO2 values within 24 h after the first IVM dose. The mean increase in SpO2 as a percentage of full normalization to SpO2 = 97 was 55.1% at +12 h and 62.3% at +24 h after the first IVM dose (paired t-test, p < 0.0000001). These results parallel similar sharp, rapid increases in SpO2, all on room air, for 24 mostly severe COVID-19 patients in the USA (California) who were given an IVM-based combination treatment. All patients in both of these critical series recovered. These rapid increases in SpO2 values after IVM treatment stand in sharp contrast to declines in SpO2 and associated pulmonary function through the second week following the onset of moderate or severe COVID-19 symptoms under standard care.
{"title":"Changes in SpO2 on Room Air for 34 Severe COVID-19 Patients after Ivermectin-Based Combination Treatment: 62% Normalization within 24 Hours","authors":"Jaqueline C. Stone, Pisirai Ndarukwa, D. Scheim, B. Dancis, J. Dancis, Martin G. Gill, Colleen Aldous","doi":"10.3390/biologics2030015","DOIUrl":"https://doi.org/10.3390/biologics2030015","url":null,"abstract":"The emergence of COVID-19 in March 2020 challenged Zimbabwe to respond with limited medical facilities and therapeutic options. Based on early clinical indications of efficacy for the macrocyclic lactone, Ivermectin (IVM), against COVID-19, IVM-based combination treatments were deployed to treat it. Oxygen saturation (SpO2) data were retrospectively analyzed for 34 severe, hypoxic COVID-19 patients all on room air (without supplemental oxygen). The patients, median age 56.5, were treated at clinics or at home between August 2020 and May 2021. All but three of these 34 patients had significantly increased SpO2 values within 24 h after the first IVM dose. The mean increase in SpO2 as a percentage of full normalization to SpO2 = 97 was 55.1% at +12 h and 62.3% at +24 h after the first IVM dose (paired t-test, p < 0.0000001). These results parallel similar sharp, rapid increases in SpO2, all on room air, for 24 mostly severe COVID-19 patients in the USA (California) who were given an IVM-based combination treatment. All patients in both of these critical series recovered. These rapid increases in SpO2 values after IVM treatment stand in sharp contrast to declines in SpO2 and associated pulmonary function through the second week following the onset of moderate or severe COVID-19 symptoms under standard care.","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42232873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-08-31DOI: 10.3390/biologics2030016
S. Pincus
In this issue of Biologics, we publish an article describing a surprising clinical effect of the anti-helminthic drug ivermectin on patients with COVID-19 [...]
{"title":"Why Are We Still Talking about Ivermectin? Editorial Note on Stone et al. Changes in SpO2 on Room Air for 34 Severe COVID-19 Patients after Ivermectin-Based Combination Treatment","authors":"S. Pincus","doi":"10.3390/biologics2030016","DOIUrl":"https://doi.org/10.3390/biologics2030016","url":null,"abstract":"In this issue of Biologics, we publish an article describing a surprising clinical effect of the anti-helminthic drug ivermectin on patients with COVID-19 [...]","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41910931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-28DOI: 10.3390/biologics2030014
Sarfaraz K Niazi
Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies and misconceptions to enable faster, safer, and more cost-effective biosimilars. This paper proposes a platform for a model guideline based on the scientific evaluation of the regulatory filings of the 130+ products approved in the US, UK, and EU and hundreds more in the WHO member countries. Extensive literature survey of clinical data published and reported, including Clinicaltrials.gov, a review of all current guidelines in the US, UK and EU, and WHO, and detailed discussions with the FDA have confirmed that removing the animal and clinical efficacy testing and fixing other minor approaches will enable the creation of a harmonized guideline that will best suit an ICH designation.
{"title":"Biosimilars: Harmonizing the Approval Guidelines","authors":"Sarfaraz K Niazi","doi":"10.3390/biologics2030014","DOIUrl":"https://doi.org/10.3390/biologics2030014","url":null,"abstract":"Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies and misconceptions to enable faster, safer, and more cost-effective biosimilars. This paper proposes a platform for a model guideline based on the scientific evaluation of the regulatory filings of the 130+ products approved in the US, UK, and EU and hundreds more in the WHO member countries. Extensive literature survey of clinical data published and reported, including Clinicaltrials.gov, a review of all current guidelines in the US, UK and EU, and WHO, and detailed discussions with the FDA have confirmed that removing the animal and clinical efficacy testing and fixing other minor approaches will enable the creation of a harmonized guideline that will best suit an ICH designation.","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44325525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-22DOI: 10.3390/biologics2030013
Vivek P. Chavda, M. Chhabria, V. Apostolopoulos
Patients with an immunocompromised state are at risk of developing a long-term infection from the coronavirus 2 that causes severe acute respiratory syndrome (SARS-CoV-2) [...]
{"title":"Aged Population and Immunocompromised Patients: Impact on SARS-CoV-2 Variants and Treatment Outcomes","authors":"Vivek P. Chavda, M. Chhabria, V. Apostolopoulos","doi":"10.3390/biologics2030013","DOIUrl":"https://doi.org/10.3390/biologics2030013","url":null,"abstract":"Patients with an immunocompromised state are at risk of developing a long-term infection from the coronavirus 2 that causes severe acute respiratory syndrome (SARS-CoV-2) [...]","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46006176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-06-13DOI: 10.3390/biologics2020012
M. Montalti, G. Soldà, Angelo Capodici, Z. Di Valerio, G. Gribaudo, Giusy La Fauci, A. Salussolia, Francesca Scognamiglio, A. Zannoner, D. Gori
Antimicrobial Resistance (AMR) has become a global threat to public health systems around the world in recent decades. In 2017, Italy was placed among the worst-performing nations in Europe by the European Centre for Disease Prevention and Control, due to worryingly high levels of AMR in Italian hospitals and regions. The aim of this systematic review was to investigate the state of the art of research on AMR in Italy over the last five years. The PubMed database was searched to identify studies presenting original data. Forty-three of the 9721 records identified were included. Overall, AMR rates ranged from 3% (in a group of sheep farmers) to 78% (in a hospital setting). The methods used to identify the microorganisms, to test their susceptibility and the criteria adopted for the breakpoint were deficient in 7, 7 and 11 studies, respectively. The main findings of our review were that most studies (79.1%) considered hospitalised patients only, 4 studies (9.3%) analysed non-hospitalised populations only. In addition, only 7 studies were multicentric and no scientific literature on the subject was produced in 7 Italian regions. In order to have a solid basis on the topic for the interventions of public health professionals and other stakeholders, studies analysing the phenomenon should be conducted in a methodologically standardised manner, should include all areas of the country and should also focus on out-of-hospital and community-based care and work settings.
{"title":"Antimicrobial Resistance (AMR) in Italy over the Past Five Years: A Systematic Review","authors":"M. Montalti, G. Soldà, Angelo Capodici, Z. Di Valerio, G. Gribaudo, Giusy La Fauci, A. Salussolia, Francesca Scognamiglio, A. Zannoner, D. Gori","doi":"10.3390/biologics2020012","DOIUrl":"https://doi.org/10.3390/biologics2020012","url":null,"abstract":"Antimicrobial Resistance (AMR) has become a global threat to public health systems around the world in recent decades. In 2017, Italy was placed among the worst-performing nations in Europe by the European Centre for Disease Prevention and Control, due to worryingly high levels of AMR in Italian hospitals and regions. The aim of this systematic review was to investigate the state of the art of research on AMR in Italy over the last five years. The PubMed database was searched to identify studies presenting original data. Forty-three of the 9721 records identified were included. Overall, AMR rates ranged from 3% (in a group of sheep farmers) to 78% (in a hospital setting). The methods used to identify the microorganisms, to test their susceptibility and the criteria adopted for the breakpoint were deficient in 7, 7 and 11 studies, respectively. The main findings of our review were that most studies (79.1%) considered hospitalised patients only, 4 studies (9.3%) analysed non-hospitalised populations only. In addition, only 7 studies were multicentric and no scientific literature on the subject was produced in 7 Italian regions. In order to have a solid basis on the topic for the interventions of public health professionals and other stakeholders, studies analysing the phenomenon should be conducted in a methodologically standardised manner, should include all areas of the country and should also focus on out-of-hospital and community-based care and work settings.","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46732491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-05-10DOI: 10.3390/biologics2020010
Md Anamul Haque, Md. Sanower Hossain, Nur Muhammad Abu Sayed, Mohammad Touhidul Islam, Md. Robin Khan, F. Ahmmed, F. T. Zohora, D. Ağagündüz, L. Ming, R. Capasso
Abelmoschus esculentus (L.) Moench, commonly known as okra, is one of the most widely used vegetable crops currently used for diabetes treatment as well. It is thought that the large amount of soluble dietary fibers present in okra is responsible for the slowing of the absorption of glucose from the gut. However, its role in concomitant administration with commonly prescribed medications, including metformin (MET) and acarbose (ACR) for diabetes, is unclear. Therefore, this study assessed the effect of A. esculentus pod extract (AEE) administered concomitantly with MET and ACR in the glucose-induced hyperglycemic mice model. The AEE was prepared using green okra pods. In this experiment, each male Swiss Webster mouse was administered a 2.5 gm/kg/BW dose of glucose via gastric lavage to induce hyperglycemia. The experimental animals were divided into five groups: (i) negative control, (ii) positive control, (iii) MET only, (iv) MET and ACR, and (v) MET, ACR, and AEE. The orally administered doses of the MET, ACR, and the extract were 150 mg/kg/BW, 15 mg/kg/BW, and 0.2 mL/kg/BW, respectively. We found that MET only and a combination of MET and ACR reduced glucose levels significantly (p < 0.01) compared to the positive control. On the other hand, when MET, ACR, and AEE were administered simultaneously, the synergistic antihyperglycemic action of the MET and ACR was diminished. After 150 min, the blood glucose level was 4.50 ± 0.189 mmol/L (iv) and 6.58 ± 0.172 mmol/L (v). This study suggests that taking AEE concurrently with MET and ACR would reduce the effectiveness of antidiabetic drugs; thereby, concomitant administration of these antidiabetic agents is not recommended. This study provides an essential basis for decision-making about the consumption of AEE with conventional medicine. Further study is required to find the molecular insight of drug interactions in combination therapy of medicinal plants for diabetes.
绿毛鼠(L.)秋葵，俗称秋葵，是目前用于糖尿病治疗的最广泛使用的蔬菜作物之一。据认为，秋葵中存在的大量可溶性膳食纤维是减缓肠道对葡萄糖吸收的原因。然而，它在与常用处方药物(包括治疗糖尿病的二甲双胍(MET)和阿卡波糖(ACR))同时用药中的作用尚不清楚。因此，本研究评估了沙豆荚提取物(AEE)与MET和ACR同时给药对葡萄糖诱导的高血糖小鼠模型的影响。AEE采用绿色秋葵豆荚制备。在本实验中，每只雄性瑞士韦氏小鼠灌胃给予2.5 gm/kg/BW剂量的葡萄糖诱导高血糖。实验动物分为5组:(i)阴性对照组，(ii)阳性对照组，(iii)仅MET组，(iv) MET + ACR组，(v) MET + ACR + AEE组。MET、ACR和提取物的口服剂量分别为150 mg/kg/BW、15 mg/kg/BW和0.2 mL/kg/BW。我们发现，与阳性对照相比，仅MET和MET与ACR联合使用可显著降低血糖水平(p < 0.01)。另一方面，当MET、ACR和AEE同时使用时，MET和ACR的协同降糖作用减弱。150min后，血糖水平分别为4.50±0.189 mmol/L (iv)和6.58±0.172 mmol/L (v)。本研究提示AEE与MET、ACR同时服用会降低降糖药物的疗效;因此，不建议同时使用这些抗糖尿病药物。本研究为常规药物使用AEE的决策提供了重要依据。药用植物联合治疗糖尿病中药物相互作用的分子机制有待进一步研究。
{"title":"Abelmoschus esculentus (L.) Moench Pod Extract Revealed Antagonistic Effect against the Synergistic Antidiabetic Activity of Metformin and Acarbose upon Concomitant Administration in Glucose-Induced Hyperglycemic Mice","authors":"Md Anamul Haque, Md. Sanower Hossain, Nur Muhammad Abu Sayed, Mohammad Touhidul Islam, Md. Robin Khan, F. Ahmmed, F. T. Zohora, D. Ağagündüz, L. Ming, R. Capasso","doi":"10.3390/biologics2020010","DOIUrl":"https://doi.org/10.3390/biologics2020010","url":null,"abstract":"Abelmoschus esculentus (L.) Moench, commonly known as okra, is one of the most widely used vegetable crops currently used for diabetes treatment as well. It is thought that the large amount of soluble dietary fibers present in okra is responsible for the slowing of the absorption of glucose from the gut. However, its role in concomitant administration with commonly prescribed medications, including metformin (MET) and acarbose (ACR) for diabetes, is unclear. Therefore, this study assessed the effect of A. esculentus pod extract (AEE) administered concomitantly with MET and ACR in the glucose-induced hyperglycemic mice model. The AEE was prepared using green okra pods. In this experiment, each male Swiss Webster mouse was administered a 2.5 gm/kg/BW dose of glucose via gastric lavage to induce hyperglycemia. The experimental animals were divided into five groups: (i) negative control, (ii) positive control, (iii) MET only, (iv) MET and ACR, and (v) MET, ACR, and AEE. The orally administered doses of the MET, ACR, and the extract were 150 mg/kg/BW, 15 mg/kg/BW, and 0.2 mL/kg/BW, respectively. We found that MET only and a combination of MET and ACR reduced glucose levels significantly (p < 0.01) compared to the positive control. On the other hand, when MET, ACR, and AEE were administered simultaneously, the synergistic antihyperglycemic action of the MET and ACR was diminished. After 150 min, the blood glucose level was 4.50 ± 0.189 mmol/L (iv) and 6.58 ± 0.172 mmol/L (v). This study suggests that taking AEE concurrently with MET and ACR would reduce the effectiveness of antidiabetic drugs; thereby, concomitant administration of these antidiabetic agents is not recommended. This study provides an essential basis for decision-making about the consumption of AEE with conventional medicine. Further study is required to find the molecular insight of drug interactions in combination therapy of medicinal plants for diabetes.","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48439329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-20DOI: 10.3390/biologics2020009
Sarfaraz K Niazi
Biosimilars have come of age over the past 17 years, with 84 approvals in the EU and 35 in the US, representing almost 90% of the world market. While the acceptance of biosimilars in the US is catching up with that in the EU, the cost benefits remain elusive due to the high development barrier and complex distribution system involved, mainly in the US. In the EU, the cost of biosimilars has already dropped 70% or more, and interchangeability is a routine in some European jurisdictions, unlike in the US, where a separate regulatory approval is required. This paper projects significant changes coming in the US and EU’s biosimilars approval requirements that will impact the approval procedures in the rest of the world, leading to dramatic changes in the cost of biosimilars to patients. This perspective is based on the author’s first-hand experience to secure FDA approvals of biosimilars and an extensive analysis of the rationality of testing to demonstrate biosimilarity. Multiple citizen petitions by the author and meetings with the FDA may have prompted the recent announcement by the FDA to award a $5 million research grant to scientists to develop novel testing models to establish biosimilarity, including modifying the interchangeability protocols. Soon, demonstration of biosimilarity will not require animal testing and, in most cases, clinical efficacy testing; over time, the clinical pharmacology testing will be reduced as the regulatory agencies develop more confidence in the safety and efficacy of biosimilars. Biosimilars have come of age; now it is the turn of the developers to grow up, and one way to show this is to challenge the current regulatory guidelines but only on scientific grounds to seek more concessions, for which both FDA and EMA are ready.
{"title":"The Coming of Age of Biosimilars: A Personal Perspective","authors":"Sarfaraz K Niazi","doi":"10.3390/biologics2020009","DOIUrl":"https://doi.org/10.3390/biologics2020009","url":null,"abstract":"Biosimilars have come of age over the past 17 years, with 84 approvals in the EU and 35 in the US, representing almost 90% of the world market. While the acceptance of biosimilars in the US is catching up with that in the EU, the cost benefits remain elusive due to the high development barrier and complex distribution system involved, mainly in the US. In the EU, the cost of biosimilars has already dropped 70% or more, and interchangeability is a routine in some European jurisdictions, unlike in the US, where a separate regulatory approval is required. This paper projects significant changes coming in the US and EU’s biosimilars approval requirements that will impact the approval procedures in the rest of the world, leading to dramatic changes in the cost of biosimilars to patients. This perspective is based on the author’s first-hand experience to secure FDA approvals of biosimilars and an extensive analysis of the rationality of testing to demonstrate biosimilarity. Multiple citizen petitions by the author and meetings with the FDA may have prompted the recent announcement by the FDA to award a $5 million research grant to scientists to develop novel testing models to establish biosimilarity, including modifying the interchangeability protocols. Soon, demonstration of biosimilarity will not require animal testing and, in most cases, clinical efficacy testing; over time, the clinical pharmacology testing will be reduced as the regulatory agencies develop more confidence in the safety and efficacy of biosimilars. Biosimilars have come of age; now it is the turn of the developers to grow up, and one way to show this is to challenge the current regulatory guidelines but only on scientific grounds to seek more concessions, for which both FDA and EMA are ready.","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47572303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-18DOI: 10.3390/biologics2010008
Julia Depta, P. Małkowska, M. Wysokińska, Karolina Todorska, Olga Sierawska, Rafał Hrynkiewicz, Dominika Bębnowska, P. Niedźwiedzka-Rystwej
Antimicrobial peptides (AMPs) have recently become widely publicized because they have the potential to function in alternative therapies as “natural” antibiotics, with their main advantage being a broad spectrum of activity. The potential for antimicrobial peptides to treat diabetes mellitus (DM) has been reported. In diabetes mellitus type I (T1D), cathelicidin-related antimicrobial peptide (CRAMP), cathelicidin antimicrobial peptide (CAMP) and mouse-β- defensin 14 (mBD14) are positively affected. Decreased levels of LL-37 and human neutrophil peptide 1-3 (HNP1-3) have been reported in diabetes mellitus type II (T2D) relative to healthy patients. Moreover, AMPs from amphibians and social wasps have antidiabetic effects. In infections occurring in patients with tuberculosis-diabetes or diabetic foot, granulysin, HNP1, HNP2, HNP3, human beta-defensin 2 (HBD2), and cathelicidins are responsible for pathogen clearance. An interesting alternative is also the use of modified M13 bacteriophages containing encapsulated AMPs genes or phagemids.
{"title":"Therapeutic Role of Antimicrobial Peptides in Diabetes Mellitus","authors":"Julia Depta, P. Małkowska, M. Wysokińska, Karolina Todorska, Olga Sierawska, Rafał Hrynkiewicz, Dominika Bębnowska, P. Niedźwiedzka-Rystwej","doi":"10.3390/biologics2010008","DOIUrl":"https://doi.org/10.3390/biologics2010008","url":null,"abstract":"Antimicrobial peptides (AMPs) have recently become widely publicized because they have the potential to function in alternative therapies as “natural” antibiotics, with their main advantage being a broad spectrum of activity. The potential for antimicrobial peptides to treat diabetes mellitus (DM) has been reported. In diabetes mellitus type I (T1D), cathelicidin-related antimicrobial peptide (CRAMP), cathelicidin antimicrobial peptide (CAMP) and mouse-β- defensin 14 (mBD14) are positively affected. Decreased levels of LL-37 and human neutrophil peptide 1-3 (HNP1-3) have been reported in diabetes mellitus type II (T2D) relative to healthy patients. Moreover, AMPs from amphibians and social wasps have antidiabetic effects. In infections occurring in patients with tuberculosis-diabetes or diabetic foot, granulysin, HNP1, HNP2, HNP3, human beta-defensin 2 (HBD2), and cathelicidins are responsible for pathogen clearance. An interesting alternative is also the use of modified M13 bacteriophages containing encapsulated AMPs genes or phagemids.","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47419268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-09DOI: 10.3390/biologics2010006
O. Oluyele, M. Oladunmoye, Ayodele Oluwayemisi Ogundare
This study evaluated the toxicological effect of oral administration of Phoenix dactylifera seed essential oil (PDEO) in Wistar rats. PDEO was extracted through a steam-distillation technique. Acute toxicity study evaluated administration of a single dose of the oil in a group (n = 5) of rats followed by 24 h observation, for sub-acute toxicity evaluation, the animals were randomly divided into five groups (n = 3). Group 1 to 4 rats, respectively, received 62.5, 125, 250, and 500 mg/kg bw of PDEO for fourteen days, while the fifth group served as control. At the termination of the study, blood samples were obtained for biochemical and hematological analyses, while vital organs were histopathologically examined. Results from this study revealed no mortality or abnormal behavioral changes in the animals. A dose-related increase in bodyweight and hematological parameters was observed across the treated groups (p < 0.05). At a dosage of 500 mg/kg bw, PDEO caused slight elevation in biochemical marker levels and mild changes in histological architecture of liver and kidney of the test rats. This study revealed that PDEO exhibited significant hematopoietic attributes with no adverse effect on the experimental rats’ vital organs at concentrations below 500 mg/kg bw.
{"title":"Toxicity Studies on Essential Oil from Phoenix dactylifera (L.) Seed in Wistar Rats","authors":"O. Oluyele, M. Oladunmoye, Ayodele Oluwayemisi Ogundare","doi":"10.3390/biologics2010006","DOIUrl":"https://doi.org/10.3390/biologics2010006","url":null,"abstract":"This study evaluated the toxicological effect of oral administration of Phoenix dactylifera seed essential oil (PDEO) in Wistar rats. PDEO was extracted through a steam-distillation technique. Acute toxicity study evaluated administration of a single dose of the oil in a group (n = 5) of rats followed by 24 h observation, for sub-acute toxicity evaluation, the animals were randomly divided into five groups (n = 3). Group 1 to 4 rats, respectively, received 62.5, 125, 250, and 500 mg/kg bw of PDEO for fourteen days, while the fifth group served as control. At the termination of the study, blood samples were obtained for biochemical and hematological analyses, while vital organs were histopathologically examined. Results from this study revealed no mortality or abnormal behavioral changes in the animals. A dose-related increase in bodyweight and hematological parameters was observed across the treated groups (p < 0.05). At a dosage of 500 mg/kg bw, PDEO caused slight elevation in biochemical marker levels and mild changes in histological architecture of liver and kidney of the test rats. This study revealed that PDEO exhibited significant hematopoietic attributes with no adverse effect on the experimental rats’ vital organs at concentrations below 500 mg/kg bw.","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47909121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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