An update on the adalimumab biosimilar landscape following the approval of the first high-concentration biosimilar

Immunotherapy ◽  
2021 ◽  
Author(s):  
Enrico Fusaro ◽  
Patrick Durez ◽  
Johannes Wohlrab ◽  
Soohyun Lee ◽  
SangWook Yoon ◽  
...  
Keyword(s):  
Development Program ◽  
Biologic Therapies ◽  
Future Perspectives ◽  
High Concentration ◽  
Clinical Development Program ◽  
The Us ◽  
The Usa ◽  
Potential Impact ◽  
Us Fda ◽  
Totality Of Evidence

Biosimilars can reduce healthcare costs and expand patient access to biologic therapies. Currently, eight adalimumab biosimilars have received regulatory approval from the EMA and/or the US FDA. Following recent EMA approval of the first high-concentration adalimumab biosimilar, CT-P17, this review provides a contemporary update on adalimumab biosimilars currently licensed in Europe and the USA. The totality of evidence from each clinical development program is summarized, and characteristics of each formulation and/or device that potentially affect the convenience of treatment for patients are discussed. Future perspectives are considered, including the potential impact of the FDA’s first interchangeability designation for an adalimumab biosimilar, ahead of their entry into the US marketplace in 2023.

scholarly journals US FDA approved therapeutic antibodies with high concentration formulation: Summaries and perspectives

2021 ◽  
Author(s):  
Shawn Shouye Wang ◽  
Yifei Susie Yan ◽  
Kin Ho
Keyword(s):  
Protein Concentration ◽  
Future Trend ◽  
Therapeutic Antibody ◽  
Formulation Development ◽  
High Concentration ◽  
Protein Formulations ◽  
Fda Approval ◽  
High Protein Concentration ◽  
The Us ◽  
Us Fda

Abstract Since 1986 when we first witnessed the approval of monoclonal antibody (mAb) Orthoclone OKT3 by the US FDA, FDA has approved 103 therapeutic antibody drugs in the past 35 years for marketing. Thirty four (34) of these 103 therapeutic antibody drugs (accounting for one third of the total FDA approved antibody therapeutics) are formulated with high protein concentration (100 mg/mL or above). These 34 high concentration antibodies are the focus of this article. The dosage forms of these 34 antibodies are analyzed and discussed in this article. The highest protein concentration of these approved mAbs is 200 mg/mL. The dominant administration route is subcutaneous (76%). Our analysis indicates that it may be rational to implement a platform formulation containing polysorbate, histidine and sucrose to accelerate high concentration formulation development for antibody drugs. The top players/sponsors of high concentration formulation are identified as Roche including its subsidiaries Genentech and Chugai, Novartis, Sanofi, Amgen, GSK, Johnson & Johnson including its subsidiary Janssen, and Regeneron. The FDA approval numbers are significantly increased since 2015 which account for 76% of the total approval number, i.e., 26 out of 34 highly concentrated antibodies. Thus, we believe that the high concentration formulations of antibody drugs will be the future trend of therapeutic antibody formulation development, regardless of the challenges of highly concentrated protein formulations.

scholarly journals Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases

2019 ◽  
Vol 15 (36) ◽  
pp. 4223-4234 ◽  
Author(s):  
Wojciech Jurczak ◽  
Stanley Cohen ◽  
Timothy M Illidge ◽  
Antonio da Silva ◽  
Jutta Amersdorffer
Keyword(s):  
Inflammatory Diseases ◽  
Safety Evaluation ◽  
Development Program ◽  
Clinical Development ◽  
Biological Data ◽  
B Cell Depletion ◽  
Efficacy Evaluation ◽  
Clinical Development Program ◽  
Hematological Cancers ◽  
Totality Of Evidence

Sandoz rituximab (SDZ-RTX; Rixathon®; GP2013), a rituximab biosimilar, was approved in June 2017 in Europe in all indications of reference rituximab. The stepwise SDZ-RTX development program generated extensive physicochemical, structural, functional, and biological data demonstrating a match with reference rituximab on all clinically relevant attributes. A focused clinical development program followed, in two indications selected for sensitivity to detect potential differences versus reference rituximab: rheumatoid arthritis (pivotal pharmacokinetics and efficacy evaluation) and follicular lymphoma (pivotal efficacy/safety evaluation). These trials demonstrated highly similar pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity profiles. The totality of evidence for biosimilarity for SDZ-RTX, combined with knowledge that B-cell depletion is common to each approved indication, allowed SDZ-RTX approval for use in all indications of reference rituximab.

IQOS marketing strategies in the USA before and after US FDA modified risk tobacco product authorisation

2021 ◽  
pp. tobaccocontrol-2021-056819
Author(s):  
Carla J Berg ◽  
Katelyn F Romm ◽  
Yael Bar-Zeev ◽  
Lorien C Abroms ◽  
Katharina Klinkhammer ◽  
...  
Keyword(s):  
Science Research ◽  
Tobacco Product ◽  
Home Delivery ◽  
The Us ◽  
Before And After ◽  
The Usa ◽  
Marketing Data ◽  
Us Fda ◽  
Ongoing Surveillance ◽  
Media Channels

IntroductionGiven that the US Food and Drug Administration (FDA) authorised reduced exposure messaging to be used in IQOS marketing, we examined: (1) IQOS ad content; (2) advertising media channels and (3) changes in advertising efforts over time.MethodsWe conducted a mixed-methods study regarding IQOS ad content (headlines, themes, images), ad occurrence characteristics (including content, media channels and adspend) in the USA from August 2019 to April 2021 using Numerator advertising/marketing data.ResultsAcross 24 unique ads and 591 occurrences (84.6% online, 8.0% print, 7.4% mobile), there was $4 902 110 total adspend (98.9% allocated to print). Across unique ads, occurrences and adspend, prominent themes included ‘real tobacco’ (45.8%, 47.4%, 30.1%, respectively), less odour/ash (29.2%, 21.0%, 29.9%) and switching from cigarettes (25.0%, 19.5%, 69.4%), and images mainly featured the product alone (58.2%, 61.4%, 99.5%) or with women (25.0%, 19.1%, 0.3%). Per occurrences and adspend, the most prominent media channel themes (eg, magazine/website topics) were technology (19.3%, 10.6%), women’s fashion (18.1%, 26.2%), weather/news (9.0%, 15.3%) and entertainment/pop culture/gaming (8.5%, 23.1%). Ad themes appearing only post-FDA authorisation included switching from traditional cigarettes, same-day/home-delivery, convenience (eg, use indoors), reduced exposure to some dangerous substances, science/research and distinction from e-cigarettes. Overall adspend per occurrence increased postauthorisation (p=0.016); the highest adspend per unique ad (69.3% of total) focused on ads featuring reduced exposure.ConclusionsRegulatory efforts must be informed by ongoing surveillance of IQOS marketing efforts and its impacts, particularly how specific consumer subgroups (eg, tobacco non-users, women, young people) are impacted by marketing exposure.

scholarly journals Peeping into the Emerging Threat of Novel Influenza D Virus: A Review

2021 ◽  
Author(s):  
Muhammad Zeeshan Akram ◽  
Ali Murtaza ◽  
Muhammad Kashif ◽  
Syed Ehtisham-ul-Haque ◽  
Aman Ullah Khan ◽  
...  
Keyword(s):  
Animal Species ◽  
Future Perspectives ◽  
Limited Data ◽  
Serological Evidence ◽  
Natural Reservoir ◽  
Current Review ◽  
The Usa ◽  
Influenza C Virus ◽  
Emerging Virus ◽  
Potential Impact

In 2011, a new virus was isolated from swine with influenza-like symptoms in Oklahoma, USA. Later in 2013, it was also evidenced in cattle, considered as its natural reservoir, elsewhere in the USA. This new virus has certain resemblance with Influenza C virus (ICV), predominately a human pathogen. Due to its inability to re-assort with ICV, it is now classified as Influenza D virus (IDV) and is a new candidate in the Orthomyxoviridae family. It causes mild respiratory disease in several animal species and replicates in both upper and lower respiratory tract. To date, serological evidence was demonstrated in various animal species and humans in all continents except Australia. It is transmitted through direct contact or through aerosol routes. Not much is known about its potential impact to animal and human health but it poses a potential risk as an emerging threat to cattle-workers. Currently, limited data is available on its global occurrence and distribution. Therefore, in current review, we summarize the global available data regarding epidemiology, pathology, zoonotic potential and future perspectives of this virus. In conclusion, continuous surveillance and risk assessment of this emerging virus is required.

Immune checkpoint inhibitors (ICI): An analysis of FDA’s and EMA’s decision patterns and times for initial approvals and extensions of indication.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14062-e14062 ◽  
Author(s):  
Christine Mayer-Nicolai ◽  
Elmar Schmitt ◽  
Markus Hartmann ◽  
Philippe Serrano
Keyword(s):  
Checkpoint Inhibitors ◽  
Regulatory Approval ◽  
European Medicines Agency ◽  
Priority Review ◽  
Marketing Approval ◽  
Cancer Drugs ◽  
Line Extensions ◽  
The Us ◽  
The Usa ◽  
Us Fda

e14062 Background: In certain clinical settings ICI have demonstrated unprecedented patterns of efficacy, resulting since 2011 in regulatory approvals worldwide in a variety of cancer indications. As immuno-oncology (IO) drugs constitute today an intense area of oncology drug development, we sought to analyze and compare the regulatory approval decisions for ICI, issued until end of 2018 by the US FDA and the European Medicines Agency (EMA). Methods: We reviewed the biological license applications (BLA) of the 7 (EU: 6) ICI, for which marketing approval decisions for were granted so far. Together with parallel and extension of indication applications, 43 (FDA) respectively 23 (EMA) approval procedures were finalized between March 2011 and December 2018. We analyzed agency decision outcomes and timeline patterns; approval decisions issued for novel non-IO cancer drugs served as benchmarks. The primary variable for analysis was median approval time (MAT). Results: MAT for initial BLA applications for ICI in the USA were with 189 days [Interquartile range (IQR) 154-209] shorter than MAT for BLA and NDA approvals for non-IO drugs: for the 51 novel oncology drugs approved 2011-2018 by the FDA, MAT was 227 days [IQR 159-303]. With 181 days [IQR 155-184], FDA’s MAT for ICI line extensions did not differ from MAT for initial ICI approvals. For the EU, MAT for initial ICI marketing applications were with 373 days (IQR 326-413) also shorter than MAT for the 51 non-IO drugs approved 2011-18 (422 days [IQR 368-450]); for ICI line extensions, MAT was 254 days [IQR 187-293). Conclusions: For ICI as for novel non-IO cancer drugs, initial regulatory approvals are usually issued in the USA first. Regulatory approval times for initial approvals are shorter in the USA, compared to Europe, the same applies for ICI extensions of indication. FDA’s extensive granting of breakthrough therapy designations (BTD) helped to bring US MAT for initial ICI BLA down to 6 months – i.e. to the same time, FDA requires for its priority review of extensions of indication. For some ICI extensions of indication, the granting of BTD supported approval decisions within 3 months, supporting patients’ rapid access to novel therapies.

Nebivolol/valsartan combination for the treatment of hypertension: a review

2020 ◽  
Author(s):  
Sarah J Wang ◽  
Gary E Sander
Keyword(s):  
Angiotensin Receptor Blocker ◽  
Multiple Drug ◽  
Clinical Use ◽  
Angiotensin Receptor ◽  
The Us ◽  
Treatment Of Hypertension ◽  
Single Pill ◽  
The Usa ◽  
Key Issues ◽  
Us Fda

Nebivolol (N) is a β1-adrenoreceptor antagonist that is approved for treatment of hypertension in the USA. Effective treatment of hypertension is becoming an increasingly difficult process that often requires multiple drug combinations to meet target guidelines. This has resulted in the increasing introduction of multidrug single-pill combinations (SPCs) to facilitate cost and compliance issues. Some of the SPCs have added valsartan (V), an angiotensin receptor blocker, which is an increasingly advocated antihypertensive class. Pharmacological profiles of N and V, alone and combined, are well characterized. In 2007, the SPC of N and V, 5 and 80 mg, respectively, was approved by the US FDA for treatment of hypertension. This paper will summarize and update key issues in pharmacology, clinical use and benefit.

Measurement Invariance of a Universal Behavioral Screener Across Samples From the USA and Germany

2018 ◽  
Vol 34 (2) ◽  
pp. 87-100 ◽  
Author(s):  
Gino Casale ◽  
Robert J. Volpe ◽  
Brian Daniels ◽  
Thomas Hennemann ◽  
Amy M. Briesch ◽  
...  
Keyword(s):  
Measurement Invariance ◽  
Student Behavior ◽  
Cross Cultural ◽  
Cross Cultural Comparison ◽  
School Based ◽  
Cultural Research ◽  
Universal Screener ◽  
Confirmatory Factor ◽  
The Us ◽  
The Usa

Abstract. The current study examines the item and scalar equivalence of an abbreviated school-based universal screener that was cross-culturally translated and adapted from English into German. The instrument was designed to assess student behavior problems that impact classroom learning. Participants were 1,346 K-6 grade students from the US (n = 390, Mage = 9.23, 38.5% female) and Germany (n = 956, Mage = 8.04, 40.1% female). Measurement invariance was tested by multigroup confirmatory factor analysis (CFA) across students from the US and Germany. Results support full scalar invariance between students from the US and Germany (df = 266, χ2 = 790.141, Δχ2 = 6.9, p < .001, CFI = 0.976, ΔCFI = 0.000, RMSEA = 0.052, ΔRMSEA = −0.003) indicating that the factor structure, the factor loadings, and the item thresholds are comparable across samples. This finding implies that a full cross-cultural comparison including latent factor means and structural coefficients between the US and the German version of the abbreviated screener is possible. Therefore, the tool can be used in German schools as well as for cross-cultural research purposes between the US and Germany.

Sanctions of the USA and the Policy of Bank of Russia:double Blow to the National Economy

2014 ◽  
pp. 13-29 ◽  
Author(s):  
S. Glazyev
Keyword(s):  
National Security ◽  
Economic Sanctions ◽  
Capital Flight ◽  
Practical Advice ◽  
The Us ◽  
Monetary Authorities ◽  
The Usa ◽  
Simultaneous Adoption ◽  
The Eu

This article examines fundamental questions of monetary policy in the context of challenges to the national security of Russia in connection with the imposition of economic sanctions by the US and the EU. It is proved that the policy of the Russian monetary authorities, particularly the Central Bank, artificially limiting the money supply in the domestic market and pandering to the export of capital, compounds the effects of economic sanctions and plunges the economy into depression. The article presents practical advice on the transition from external to domestic sources of long-term credit with the simultaneous adoption of measures to prevent capital flight.

Possibility of Using in Russia the Experience of LED Lighting Application at the USA Airfields

2019 ◽  
pp. 71-77
Author(s):  
Vladimir V. Vorozhikhin ◽  
Eugenia L. Moreva ◽  
Vladimir G. Starovoytov ◽  
Igor G. Tyutyunnik
Keyword(s):  
Air Transportation ◽  
Improve Quality ◽  
Led Lighting ◽  
The Us ◽  
The Usa ◽  
Quality And Reliability ◽  
Lighting Application

The purpose of this paper is an investigation of LEDs illumination experience at US-based aerodromes with an assessment of its feasibility and its necessity in Russia. The following methods were used: the analysis of aerodrome lighting requirements; the review and the analysis of development features in aerodrome LEDs illumination; the experience analysis of LEDs illumination of US-based aerodromes; the deductive analysis and the assessment synthesis of feasibility and necessity of US experience in LEDs illumination at Russian-based aerodromes. The following results were achieved: – The analysis of issues and opportunities was conducted for development of LEDs illumination at US-based aerodromes and of American experts’ recommendations for its use; – The cases were taken for use and assessment of development in LEDs illumination at US-based aerodromes; – The review and the analysis were conducted in relation to a developing market of LEDs illumination at Russian-based aerodromes. The main conclusion is that the US experience will improve quality and reliability of service provided in air transportation, comfort, and safety of Russian flights, as well as competitiveness of Russian- based airports and airlines (indirectly).

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