A biosimilar is a biological medicine, approved by the regulatory bodies based on a high similarity to a pre-existing approved innovative biological product, also referred as reference medicine or originator medicine. The medicine is highly similar, comparable version of an approved biologic medicine. The medicine includes active ingredients identical to the reference small–molecule drugs which differentiates the medicine from generic medicine. Biosimilars are un-identical to the reference biologics including the proprietary details of the reference product and the inherent complexity of biologics. Thus, biosimilars prepared by various manufacturers varies from the reference product making each drug a unique therapeutic option for patients.
Biosimilars are expected to be more affordable therapeutic options based on the complexity, cost of development and manufacture. However, it is not expected to generate the same level of cost savings as generics. Growing demand for biologic medicines is considered to drive the industry growth over the forecast period. Increase in the demand for biosimilar drugs owing to their cost-effectiveness and the rising incidence of chronic diseases are also projected to spur the industry growth.
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Top Industry Player’s
Pfizer, Teva Pharmaceuticals, Sandoz International, Dr. Reddy’s Laboratories, Amgen, Biocon, Samsung Biologics and Celltrion.
The pricing of biosimilar drugs, rising number and quality of tertiary care centers is expected to enhance the application of biotech products, hence driving success in the biosimilars market. The existence of broad range of therapeutic proteins and multiple biosimilar versions of monoclonal antibodies at a relatively low cost in comparison to reference products are also significant factors driving the biosimilar market.
Increased application of traditional generic drugs and patent expiration of various innovator drugs is expected to be the factors leading to a shift of focus in the pharmaceutical industry towards investment in specialty drugs and high growth areas. Rising life-threatening disorders such as cancer and diabetes with increasing geriatric population has led to the utilization of expensive biopharmaceuticals. Furthermore, governments are switching to affordable alternatives owing to growing emphasis on cost effectiveness and patent expiration of key product classes. Thus, there is a tremendous opportunity for biosimilar manufacturers over the forecast period. However, the development of biosimilar drugs is riddled with complexities.
The R&D of the drug, followed by manufacturing and marketing of the drug, is one of the most expensive propositions in the pharmaceutical industry. Patent expiration of biologic drugs over the few years will lead to the acceptance of biosimilar medicine in the industry. According to study, more than 40 biosimilars are under development out of which approximately 20 biosimilars are ready to be released into the market and a significant number of biosimilars are in the pipeline. This will further significantly reduce the costs for patients and health systems. However, the process is anticipated to pose multiple challenges for regulators for confirming the similarity of the biosimilar to the original biologic in terms of efficacy and safety.
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The United States Congress established an abbreviated and distinct pathway for the approval of biosimilars, for recognition of the unique and complex properties of biologics. The pathway requires additional evidence beyond the requirements for generic drug approval, including added analytical characterization and non-clinical as well as clinical data. Owing to the complexities, the development and manufacture of high-quality biosimilars requires manufacturers to have a scientific and manufacturing expertise.
Europe region has been accounted for the largest share in biosimilar market in 2017 and it is expected to be the major contributor to the Biosimilar revenue globally over the forecast period. Growing biotechnology companies in the Asia Pacific region, supported by immense economic development is expected to record a robust growth in biosimilar market over the forecast period thereby making Asia Pacific the major contributor to global biosimilar market. Rising incidence of chronic disorders, patent expiry of biological products, the emergence of new market participants and the launch of new biosimilars are further expected to boost the regional market.
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