Abstract of Dissertation

Agency : Market Opportunity, Biosimilar Regulatory Approva, Regulatory Environment, Pharmerging Market

Background : The pharmaceutical industry is experiencing change even policy makers are struggling with an inherent conflict between desire to provide improved access to better medicines and the need to curb the growth of healthcare expenditures. One topic at the centre of all of these changes is the Biosimilars market. Biosimilar products will offer competition to biologic which are some of the most expensive drugs in pharma market. The promise of biosimilars is to provide cost savings, increase patient access, and promote innovation. However, Regulatory environment plays a very big role in determining the 56 market for biosimilars in all geographies across the globe. Regulations have been set in place in order to prevent the launch of inappropriate biosimilars. This offers entry barrier for new players and also established pharmaceutical manufacturers want to enter suitable markets in terms regulatory setting. This exploratory secondary research study helps finding out the most opportunistic markets based on available secondary data in seven Major Markets (EU5, U.S., Japan) and two Pharmerging markets (China and Russia) taking specific regulatory parameters into consideration. Opportunity assessment will help pharma MNC’s to decide upon which geographies they should go to for investment into biosimilars depending upon favorability of market from regulatory perspective this is because biosimilars involve huge investment. Research Questions: a) What are the common regulatory perspectives being considered across the target geographies in relation to the biosimilar regulatory approval process? b) Which geography/geographies offer the most opportunistic market from a regulatory perspective to the players interested in entering the biosimilar landscape? Accordingly, Research Objectives were formulated such as a) To study the overall regulatory environment for biosimilars in the 7 major markets (EU5, U.S., and Japan) and two Pharmerging markets (China and Russia). b) To determine and pick up those biosimilar regulatory parameters that has greatest influence in determining the regulatory scenario in these geographies. c) To determine compliance of geographies under consideration to the decided parameters and allotting the ranks accordingly. d) To determine the most opportunistic geography/geographies as a biosimilar market from regulatory environment perspective based on rankings The Methodology was followed to fulfill and achieve all objectives involved in selecting study geographies followed by literature review of regulatory settings that exist in these geographies for biosimilars, followed by deciding upon the parameters that need to be assessed. The following parameters have been taken into consideration: Existence of legislation for regulatory approval pathway for biosimilar, Reference Product Approval required in the Domestic Country, Status of Indication Extrapolation of Biosimilars, Support by the government policies to Local /MNCs biosimilar manufacturer, Status of Biosimilar Interchangeability, Status of Biosimilar Substitutability, Domestic trial requirements. In accordance to the different variations in parameters on studying parameters in the geographies under study Likert’s scale was developed and used as a tool to rank the regulatory scenario on a scale of 1 to 5 where 1 means least opportunistic (most restrictive market) and 5 being most opportunistic (least restrictive market). Later weights have been allocated to study parameters and relative ranking was calculated for study geographies and lastly, overall relative ranking is carried out which is a cumulative score of relative ranking. Finally findings were obtained where United States achieved the highest overall relative rank thereby suggesting that it offers least restrictive market for biosimilar regulatory approval followed by its launch in the market, the next best market is offered by Germany and Italy among all other EU5 countries.

Recommendations : Based upon the study results the United States came out to be most opportunistic or in other way least restrictive market for biosimilar manufacturers because of following reasons: U.S. government has allowed use of reference product from other countries as it is unlike Europe where only approved drugs in the country can be just outsourced in batches from other countries. The key feature of their regulation is accepting “Interchangeability” (this term has been introduced by United States) and Substitution unlike in Europe. However, United States needs to look up to Europe For or creating more positive regulatory environment for biosimilars in terms of allowing for indication extrapolation. Europe’s biosimilar legislation is well established and accepted as a gold standard Keywords used are: Biosimilars regulatory approval pathway in Europe, United States, Japan , China, Russia, Biosimilar Regulatory Authorities in EU5, U.S., Japan, China, Russia, status of interchangeability and Substitutability, Status of indication extrapolation EU5, U.S., Japan.