Biography
Biography: Maen A Addassi
Abstract
For many years, generic versions of those medicinal products have been on the market that contains chemically synthesized active ingredients. These generics are essentially similar to the innovator’s product and contain the same active ingredient in the same quantity. Such generic products may be approved after the patent for the innovator’s product has expired. Neither efficacy nor safety studies are required for the approval of a generic drug; it is sufficient to refer to the documentation provided by the innovator. With more number of new mABs, coupled with the expiry of the patents and more affordability is expected to generate the overall sales of nearly US$125 billion in the next 4-5 years. Monoclonal antibodies (mAbs) contribute almost 60% of market revenue among the top ten bestseller drugs worldwide. The growth of the biosimilar market is driven by the numbers of patents getting expired in the coming years, regulations and guidelines for the manufacturing of different class of biosimilars and potential demand for these products. Although, a few new mAbs that have gained regulatory approval in the last few years, it is expected to have 70 mAbs product in the global market by 2020. The market for mAbs is expected to grow in near future due to, patent expiry of few blockbuster drugs and new products in the pipeline. European and US market is wide open due to the patent expiry which influences the Asian drug makers. It is expected that the emerging Biosimilars market, especially in China, India, Brazil and MENA will record high growth rate driven by cost-effectiveness of Biosimilars and the growing awareness supported by growing healthcare infrastructure in these countries.