Research Journal of Pharmacology and Pharmacodynamics

Nikhil Kute ¹, S. D. Mankar ¹, S. B. Bhawar ¹

Affiliations
1 Pravara Rural College of Pharmacy, Pravaranagar, IN

Abstract

Biosimilars are biological products that are the replicas of their innovator biopharmaceuticals. The term “biosimilar” is in common use in the European Union, while the term “follow on biologics” is more popular in the American context. These are developed after patent expiration of innovator biopharmaceuticals and are submitted for separate marketing approval. In view of the structural and manufacturing complexities of biopharmaceuticals, biosimilars should not be considered as “biological generics”. These are rather unique molecules with limited data at time of approval, so there are concerns about the safety and efficacy of biosimilars. The Indian biotechnology industry is also gaining momentum, with revenues of over U.S. $ 2.0 billion in 2006, 70% of which is biopharmaceuticals. These are projected to reach up to $580 million in 2012.This article will address the differences between biosimilars and chemical generics, issues of concern with the use of biosimilars and need of appropriate regulations for their approval.

Keywords

Biosimilar, Chemical generic, Current status, Issues concern, FDA approach.

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Avesh Tamboli ¹, Priyanka Sadaphal ¹, S. D. Mankar ¹, S. B. Bhawar ¹

Affiliations
1 Pravara Rural College of Pharmacy, Pravaranagar (Loni BK), Ahmednagar, Maharashtra, 413736, IN

Abstract

Kounis syndrome is characterised by a group of symptoms that manifests as unstable vasospastic or nonvasospastic angina secondary to a hypersensitivity reaction. It was first described by Kounis and Zavras in 1991 as the concurrence of an allergic response with an anaphylactic or anaphylactoid reaction and coronary artery spasm or even myocardial infarction. Since then, this condition has evolved to include a number of mast cell activation disorders associated with acute coronary syndrome. There are many triggering factors, including reactions to multiple medications, exposure to radiological contrast media, poison ivy, bee stings, shellfish, and coronary stents. In addition to coronary arterial involvement, Kounis syndrome comprises other arterial systems with similar physiologies, such as mesenteric and cerebral circulation resulting in ischemia / infraction of the vital organs. The Incidence of this condition is difficult to establish owing to the number of potential instigating factors and its relatively infrequent documentation in the literature. Anaphylaxis rarely manifests as a vasospastic acute coronary syndrome with or without the presence of underlying coronary artery disease. The variability in the underlying pathogenesis produces a wide clinical spectrum of this syndrome. Kounis syndrome is not just a single organ but also a complex multisystem and multiorgan arterial clinical conditions, it affects the coronary, mesenteric, and cerebral arteries and is accompanied by allergy hypersensitivity anaphylaxis involving Skin , respiratory system and vascular system in the context of anaesthesia, surgery, radiology ,oncology or even dental and psychiatric medicine , further it has significantly influences both morbidity and mortality. Kounis syndrome is caused by inflammatory mediators released during allergic insults, post inflammatory cell activation and interactions via multi directional stimuli. A platelet subset of 20% with high and low affinity IgE surface receptors is also involved in this process.

Keywords

Acute coronary syndrome, Mast cell, Histamine, Leukotriene, Kounis syndrome.

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