Biosimilars Market – Overview and a Global Outlook
Unlike generic drugs in which the active ingredients of the drugs are identical, biosimilars are identical to, but are not copies of the original biologic drug. They are identical, but not the same as them. Biologic drugs differ from each other, from the original product as well as differ with different manufacturers. The complex nature of biologics rules out the possibility of having copies and therefore biologics are different from the generic drugs. Due to the huge numbers of processes involved in production of biologics, coupled with their complex nature, biosimilars are identified on the basis of similarities between analytical, clinical and non-clinical data with structural characteristics, efficacy and safety features of the generic drug.
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Minor differences with active ingredients are considered negligible so long as any such differences are demonstrated not clinically significant. Patents of a large number of biologic drugs have either already expired or are on a verge of expiration, which has led to the rising interest in research and development activities in the field of biosimilars.
Global Biosimilars Market – Market Statistics
Countries from over the world are facing an increase in chronic health conditions, and a growing, ageing population. Expanding demand for good healthcare following from this brings forth the challenge of controlling the expenditure spent on healthcare. Introduction of biosimilars in the market is expected to increase access to the much needed biologic medicines and reduction of cost required by effective healthcare.
Over the past few years, the biosimilars market has observed the introduction of complex biosimilars that seek to replace the approximately $80 billion worth market of many biologic drugs that will face patent expiry by 2020. Monoclonal antibodies and fusion drugs with proteins as their main component, used for treating autoimmune diseases and cancers, are expected to form a substantial portion of this new line of biosimilars. The market of biologic medicines is expected to rise to $200 billion by the end of 2015, with the biosimilars market acquiring a small but substantial proportion of nearly $2.5 billion.
Global Biosimilars Market – Competitive landscape
The complex nature of biologics and similarly complex regulations involved in manufacturing to approval to marketing of biologics, the market of biosimilars require companies to have an effective combination of experience, capacity and capability. Not many companies in the drug industry have a good mix of these features, making them unable to enter the biosimilars market. This has required major companies wishing to enter or compete in the global biosimilars market to either elevate their in-house capabilities or enter in deals with companies possessing these qualities. As such, the competitive landscape of the global biosimilars market is not one that portrays many companies operating and vying for a share of the market. In the relatively new market of biosimilars, the companies that innovate first and introduce products at the quickest pace will win. The market currently features hybrid of innovators and generic drug-maker partnership businesses and biotech companies.
Competing in the biosimilars market requires enough investments to gain access to biologic manufacturing capabilities. For many companies interested to venture biosimilar market, this is the major hurdle as the costs associated with commercial scale biomanufacturing are enormous. Competitors have gained access to biologic manufacturing capabilities through deal making or by investing for building new facilities.
Many innovators have also heavily invested for building biologic manufacturing capabilities spanning different countries across the globe, and especially in Asia due to expert workforce available at cheap rates in Asian countries. Some leading global drug manufacturers including Novartis, GlaxoSmithKline (GSK), Lonza, Amgen and Genentech have decided to build commercial biologic manufacturing plants in Asia. Some Asian companies such as Genor Biomanfuacturing, Samsung, and Kemwell have also invested heavily in building their own biologic manufacturing capabilities.
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The following article is from one of our external contributors. It does not represent the opinion of Benzinga and has not been edited.