Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation
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REVIEW ARTICLE
Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation Sandeesha Lunawat1 · Krishnamurthy Bhat1 Received: 29 March 2019 / Accepted: 9 December 2019 © The Drug Information Association, Inc 2020
Abstract The regulatory agencies all over the world have defined the pathway and regulations for the approval of simple small-molecule generics. In addition, the agencies are striving to form perspicuous regulatory frameworks for the approval of biosimilars. In this view, there are no defined regulations for the approval of complex generics, also known as non-biological complex drugs (NBCDs). Complex drugs are large, highly complex and synthetic moieties and are made of complex active substances but are different from biologics product. Regulatory frameworks being adopted for complex generics today are questionable and ambiguous. The market for complex generics is huge and there are fewer generic competitors in this area. In addition, the cost of bringing such generics into the market is high. Since the complex generics are largely used for chronic and lifethreatening diseases and the competition is less, generic players show high interest in this segment. Thus, there is a need for a well-defined pathway and guidance documents for the authorization of generic versions of complex drug products. The article focuses on the regulatory frameworks currently adopted by US, EU and Canada for bringing complex generics into the market. It also describes on the regulatory disparities existing among the three agencies in the light of complex generics. Keywords Complex drugs · Complex generics · Non-biological complex drugs · Harmonisation · Follow-on products
Introduction The pharmaceuticals are divided as: simple drugs, complex drugs and biologics. The drug products can be either innovator product or its generic version. In case of simple generic drug products, the market opportunities are abating along with price reduction. This is due to ever-growing competition within the distribution system or channel all over the world, especially in the regulated markets such as the U.S, EU and Canada. Thus, the drug manufacturers are inclined towards the development of complex generics rather than the simple generics. The market of complex generics has high value due to lesser competition. Till date, competition for the complex generics market is less. The patents and exclusivities of many complex products are near expiry in
* Krishnamurthy Bhat [email protected] 1
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Madhavnagar, Manipal, Udupi, Karnataka 576104, India
these regions which has boosted the generic market of these products [1]. Complex drugs are large, highly complex and synthetic moieties and are made of complex active substances but are different from biologics product. Such complex products are used to treat complicated chronic and lethal diseases such as Hepatitis C
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