Title:A Comparative Study on Approval of Follow-on Version of Sevelamer
Carbonate and Glatiramer Acetate (GA) in US, EU
Volume: 10
Author(s): Nisha Sankhwar*Vikesh Kumar Shukla
Affiliation:
- Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida – 201313, India
- Central Drugs Standard Control
Organization (CDSCO), Food and Drugs Administration (FDA) Bhavan, Kotla Road, New Delhi – 110002, India
Keywords:
Sevelamer carbonate, glatiramer acetate, follow-on version, non-biological complex drugs, innovator, patients.
Abstract:
Many non-biological drugs, different in terms of their structure and mode of action,
pharmacological classification, and therapeutic indication, have a common factor of structural
complexity and are grouped as non-biological complex drugs (NBCDs). When an innovator drug
nears the time of off-patent, different manufacturers attempt to produce its subsequent version, so
the patients will have a cost-effective therapeutic equivalent. Since the innovator molecule is complex,
its follow-on drug can be called its true generic version, if its bioavailability, bioequivalence
and therapeutic equivalence to the innovator drug are demonstrated. However, it is observed that a
case-to-case basis approach is implemented by European Medicines Agency (EMA) and Food and
Drug Administration, US (USFDA) in the approval of such drugs and there is no uniformity observed
between the two.
In this study, an attempt is made to study the complexity of molecules compare and understand the
data requirements, and procedures adopted for the review and approval of such complex products.
Therefore, drug sevelamer carbonate and glatiramer acetate are selected for the study. A methodical
approach was followed. European assessment reports and drug approvals available in the orange
book database of the former two regulatory agencies were studied. It is observed that the generic
version of glatiramer acetate is approved as an abbreviated new drug application (ANDA) by
Food and Drug Administration whereas the same was approved as the hybrid application by European
Medicines Agency requiring the applicant to generate and submit more data. Thus, harmonization
of the regulatory requirements for the approval of follow-on versions of such complex drugs
is essential for better understanding, predictability of the regulatory process, and acceleration of the
drug approval process, in the interest of patients. This will help the faster access of the drugs to the
patients and allow interchangeability of the innovator drugs with its cost-effective generic version.
