Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Overview.

Biopharmaceutical medicines are complex molecules obtained from a living organism (plant or animal cells) and may contain components of a living organism using biotechnology. Biosimilars are closely similar to already approved biopharmaceutical products that could form a new generation of medicines that are available widely at an affordable cost. The expiry of patent and data protection of Remicade (infliximab) aggravated biosimilar acceptance in the open market. Analysis of data package submitted for infliximab biosimilar and assessment reports published by agencies shows the importance of European Medicines Agency (EMA) product-specific guidelines (monoclonal antibodies) that are being followed by different regulatory agencies worldwide. Considering utilization of case-by-case basis for biosimilar development, infliximab biosimilar product evaluation assessment report suggests similarity in nature and extent of data required in analytical, nonclinical, and clinical studies even on utilizing cell lines different from the reference product's. Specific additional clinical study (phase III) is required for a biosimilar to be authorized by the Ministry of Health, Labour and Welfare (MHLW). US Food and Drug Administration and EMA widely accept the concept of extrapolation to other indications approved for the reference product. However, the Ministry of Health, Labour andWelfare, Japan shows a conservative approach for extrapolation to other indications in the absence of direct or indirect safety and efficacy data.

An Overview of the Drug Registration Requirements for Export to Tanzania, Nepal, and Cambodia.

In the semiregulated market, different countries have varying requirements of registration for export to such a specific country or region. The objective of the present study is to give a comparative overview of pharmaceutical registration requirements for export to Tanzania, Nepal, and Cambodia. In the African region especially, east Africa including Tanzania is an emerging market for pharmaceuticals. The Tanzania Food and Drugs Authority is the drug regulatory body in Tanzania and it follows the Common Technical Document (CTD) format for dossier submission. However, Nepal is still a developing country with respect to the pharmaceutical sector. The drug governing body in Nepal, Department of Drug Administration, has its own nation-specific guidelines for drug regulation, but the CTD format is also acceptable for dossier submission. In Cambodia, the Department of Drugs and Food is the drug regulatory authority that comes under the Ministry of Health of Cambodia. As Cambodia is included in the Association of Southeast Asian Nations (ASEAN) body, it follows the ASEAN CTD (ACTD) format for dossier submission.