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7 articles for “Biosimilars”
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A Futuristic concept of understanding Biosimilars in the Pharmaceutical Field
Abstract: Biosimilars, which are highly similar versions of approved biologic drugs, are expected to continue their expansion into new therapeutic areas, offering cost-effective alternatives to a wider range of medical conditions. This evolution includes the development of next-generation biosimilars with improved properties, such as enhanced efficacy, safety, and patient convenience. Innovations in drug delivery methods, reduced immunogenicity, and personalized medicine are anticipated to drive the development of biosimilars tailored to individual …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 14, Issue 3, 2023 · pp. 10–20 Read article
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Regulatory Requirements for Registration of Biosimilar Products and Imports in India: A Recent Scenario
Abstract: The main aim of this article is to study the various biosimilar products registration processes, regulations in imports and requirements by the Indian Regulatory Authorities. The study emphasizes on the challenges faced by stakeholders entering into the Indian market without difficulty by demonstration of strategy arrived from the established guidelines, regulations and expert opinion. The study was undertaken to identify the challenges in biosimilar developments and to evaluate the available …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 32–39 Read article
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Innovations in Oral Drug Delivery: Challenges and Opportunities
Abstract: The advancement of novel drug manufacturing technologies offers immense opportunities for innovation but brings regulatory complexities that must be addressed to ensure successful implementation. Early and frequent collaboration with the FDA is fundamental for overcoming these challenges. The establishment of the FDA’s Emerging Technology Team has been pivotal in fostering open dialogue, brainstorming, and feedback between regulators and innovators, reducing the likelihood of unexpected setbacks that could jeopardize projects. Mechanisms …
Published in Trends in Drug Delivery · Vol. 12, Issue 1, 2025 · pp. 31–43 Read article
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Role of Enoxaparin in the Management of STEMI: An Indian Perspective
Abstract: Cardiovascular diseases are major causes of morbidity and mortality worldwide. Acute coronary syndrome is one of the main causes of hospital admissions. ST-elevation myocardial infarction is the severe dreaded ACS causing morbidity and mortality. Probably because of economic reasons, conventional heparin continues to be the main anticoagulant therapy in STEMI. Enoxaparin is safe and effective in the treatment of ST-elevation myocardial infarction. Various studies outline its efficacy and safety in …
Published in Research and Reviews: A Journal of Medicine · Vol. 2, Issue 1, 2012 · pp. 15–20 Read article
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Regulatory Concerns in Imports, Exports and Registration of Drugs and Dietary Supplements
Abstract: The main aim of this article was to study the various pharmaceutical products registration processes, regulations and requirements by the Indian Regulatory Authorities. The study emphasizes on the challenges faced by stakeholders entering into the Indian market without difficulty by demonstration of strategy arrived from the established guidelines, regulations and expert opinion. The study was undertaken to identify the challenges in biosimilar developments and dietary supplements and to evaluate the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 1, 2017 · pp. 13–22 Read article
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Biobetter Formulations: Innovative Milestone for Original Biologics
Abstract: The expression "biobetter" was probably designed by Mr. G.V. Prasad, CEO of Dr. Reddy's Laboratories, at a Bioinvestor's gathering in Mumbai, India, in 2007 and has been too much utilized from that point onward, potentially to a certain extent, where there is no brought together definition for this advertising term. [2]. Biobetters or biosuperiors are new biologic substances that are enhanced variants of a unique biologic. The separation from the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 7, Issue 2, 2020 · pp. 62–71 Read article
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Significance of Randomized Clinical Trials
Abstract: The most exacting and reliable research tool for determining if there is a cause-and-effect relationship between an intervention and a result is the randomized controlled trial. When assessing the efficacy and safety of an intervention, a randomized controlled trial can produce high-quality evidence. Every randomized controlled trial (RCT) ought to have predetermined primary outcomes, be registered with a clinical trials database, and possess the necessary ethical permissions. The quality of …
Published in Research and Reviews: A Journal of Pharmacology · Vol. 13, Issue 3, 2023 · pp. 12–16 Read article