This report covers information on biosimilar drugs that are manufactured for commercial purposes in compliance with the European Medical Association, U.S. FDA and other regulatory authorities. These biosimilar drugs include erythropoietin, interferon, insulin, monoclonal antibodies (MAbs), granulocyte colony stimulating factors and others. However, vaccines, plasma derived products and their recombinant versions are excluded from the scope of this report. Furthermore, biologic drugs such as streptokinase and hyaluronidase are excluded from the study due to the absence of proper biosimilars guidelines.
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Patent expiry for reference biologics is setting the pace for the growth of biosimilars in this highly competitive market. Recreating the patented protein structure for biosimilars is a key challenge for regulators, as no two products can be exactly the same, which further complicates the regulatory process. Global biopharmaceutical regulators face numerous issues pertaining to the approval of biosimilars for various products, as the regulations drafted for each product is specific to their formulation structure. Hence, the regulatory authorities face complications in authenticating the new biological product as an NME. Additionally, there exists a dilemma in prescribing these medicines, if the regulatory authorities consider biosimilars as interchangeable. However, few regulators are approving numerous biosimilar products. Health Canada denies the identity of biosimilars as interchangeable; instead they strongly recommend it to be a completely different product. Furthermore, they consider these Biosimilars as SEBs (subsequent-entry biologics).
FDA remains imprecise on interchangeability issues of the Biosimilars. The U.S. FDA, in 2010, has passed two acts, namely BCPI (Biosimilar price Competition and Innovation) and PPACA-FDA (Patient Protection and Affordable Care) in order to sort out the interchangeability concerns. However, these guidelines still do not suffice the need to address the existing interchangeability concern. Moreover, the U.S. is a dodgy territory for many regulatory agencies due to the pressure created to fulfill demands from branded industry, legislators, patient groups, the generics industry and safety advocates. Therefore, regulators have to be very careful while calibrating release draft regulations and guidance, which has been a slow process historically. The principal trend followed by global regulators is to draft guidance for specific classes of biosimilar drugs such as to demonstrate bio-similarity for distinct products like alpha, beta interferon and biotechnology-derived proteins. Thus, drafting such guidance would drive the market of biosimilars.
Recent approval of first monoclonal antibodies in the United States under the guidance of the U.S. FDA has initiated a new trend of cancer therapeutic biosimilar in the globe. Numerous companies are struggling with approvals for their biosimilar drugs, due to unavailability of favorable regulatory compliance and heavy retaliation from the reference product manufacturers. Moreover, the consumer preferences and the prescription patterns of physicians in the United States are more inclined towards reference products. Hence, there is high demand of patented drugs. A high demand for biosimilar products is observed in the European Union. This high demand is supplemented by favorable support from the government authorities pertaining to the research and commercialization of final products. Further, the regional proximity of Asian countries with the Europe increases the requirement of cost effective medication. The government authorities across Asia-Pacific region are trying to reduce their healthcare burden by promoting the use of biosimilars.
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Chapter: 1 INTRODUCTION
1.1 Key Benefits
1.2 Key Market Segment
1.3 Research Methodology
1.3.1 Primary Research
1.3.2 Secondary Research
1.3.3 Analyst tools and models
Chapter: 2 EXECUTIVE SUMMARY
2.1 CXO perspective
2.2 Market beyond: what to expect by 2025
2.2.1 Moderate growth scenario
2.2.2 Rapid growth scenario
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