Phani Kishore Thimmaraju
Posters: J Bioanal Biomed
The cost associated with the treatment of rheumatoid arthritis has become increasingly difficult to manage over the recent years. Although the targeted therapies have revolutionized the treatment of several rheumatic diseases, the high cost associated with these therapies has become a burden on payers. With the market exclusivity of major biologics to treat RA is near to expire, the focus has shifted to develop biosimilars with comparable efficacy and safety. Apart from scientific advancement and reverse engineering, increasing demand for cost effective biologics is a determinant factor to develop biosimilars. Increasing penetration and uptake of EPO (Epoetin) biosimilars particularly in EU 5 countries in the last five years suggests their growing popularity. In 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Remsima and Inflectra (Infliximab biosimilar). This is a remarkable support from EMA (European Medicines Agency) to the pharmaceutical companies developing monoclonal antibody (mAb) biosimilars for rheumatoid arthritis. Currently, the issues on interchangeability and substitution have become the locus of debate for the approval of biosimilars and needs to be resolved at the earliest. Similar to hormone biosimilars currently marketed worldwide, the biosimilar mABs are also expected to be launched at a price around 25% less than the originator. Addressing the concerns on efficacy and safety issues, the price factor might give biosimilars an added advantage in gaining acceptance from various stakeholders.
Phani Kishore Thimmaraju is a Consultant at Phamax AG and is associated with competitive intelligence division at Bangalore office. He graduated in pharmaceutical science and holds Master?s diploma in Biotechnology from University of Essex, UK. He has over five years of experience in business intelligence and allied areas. He has conducted several workshops and presented at international conferences. He has published peer reviewed articles and white papers in reputed journals and company website.
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