Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation

Sandeesha Lunawat, Krishnamurthy Bhat

Research output: Contribution to journalReview articlepeer-review

8 Citations (Scopus)


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 life-threatening 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.

Original languageEnglish
JournalTherapeutic Innovation and Regulatory Science
Publication statusPublished - 01-09-2020

All Science Journal Classification (ASJC) codes

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)


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