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Biological products or biopharmaceuticals are medicinal products derived from living organism systems and manufactured by using modern biotechnology that differ widely from the conventional synthetic drugs. They are much larger and more complex molecules with inherent diversity; hence, different manufacturers cannot produce identical biological products, even with the same type of host expression system and equivalent technologies. Thus, biologics manufactured and marketed after patent expiration are usually referred to as biosimilars. Biosimilars endeavor to copy the original technology leading to the production of innovative biotechnological medicines to obtain a product which is similar to the reference product. These products reported to improve the treatment landscape for multiple diseases, particularly in the areas of oncology, blood disorders, rheumatology, endocrinology and are becoming choice of treatment regimen due to policy push by governments for it's affordability without comprising on quality, safety and efficacy. Pharmaceutical exports from Brazil increased by around 41% between 2009 and 2013, touchinga high of U.S. $1.516 billion. The valuation of Brazilian pharma markets has shown double digit growth in the past decade. Between 2012 and 2015, market valuations have increased from U.S. $25.2 billion to U.S. $35.3 billion. Biosimilarity is based on a comprehensive comparability exercise wherein unavoidable clinical differences are evaluated and must meet equivalence or non-inferiority criteria. Biosimilars need to comply with different regulatory requirements for market authorization in different sites. There are several other related issues that need to be defined by the national authorities, such as interchangeability, labeling and prescribing information. The Brazilian health surveillance agency shadows the key principles established by the World Health Organization for the assessment of biosimilarity. However, the regulations also widen the gap by having standalone application pathway that ...

Biological products or biopharmaceuticals are medicinal products derived from living organism systems and manufactured by using modern biotechnology that differ widely from the conventional synthetic drugs. According to some estimates, Russia is poised to be among the top five global pharmaceutical Markets in terms of value in the next couple of years. Due to the impetus shown by the government regarding the evolution of the Russian regulatory framework for pharmaceutical products, this and other market trends suggest that Russia will soon become a powerhouse destination for pharmaceutical manufacturers and contract research organizations. Russian law allows the registration of biological drugs defined as medicinal products containing a biological active substance. A bio­logical active substance is a substance that is produced by or extracted from a biological source and requires physical, chemical and biologi­cal testing, characterization of its quality, along with its production process and control. It does not define a biosimilar, nor it provides a regulatory framework for the biosimilar approval; this implies that a full clinical developmental program, similar to the innovator biologi­cal product, must be completed even for a biosimilar. An applicant must submit a registration dossier to the Ministry of Health (MoH), the regulatory body for drugs evaluation, with its affiliation Federal State Budgetary Institution - Scientific Centre for Expert Evaluation of Medicinal Products (FSBI-SCEMP). The complete dossier in Russian must be submitted to the MoH, and should include administrative doc­uments, description of pharmaceutical properties and data about the manufacturing process, quality control, preclinical studies (pharmaco­logical and toxicological) and clinical studies regarding the biological drug. Russia follows the European Guidelines for biosimilars for data requirements for the registration of a biological drug. Today, Russia stands on the verge of becoming a major force in the global pharmaceutical ...