A biosimilar medicine possesses the similar pharmacokinetic and mode of action as an original biological medicine that has already been approved for therapeutic use. Biosimilars are made from a living organism such as bacteria and yeast or can also be derived from small molecules like human insulin, erythropoietin and monoclonal antibodies via recombinant DNA and gene expression technologies. Biosimilars are developed only when original biological medicines are commercially expired and therefore are known as follow on biologics or subsequent entry biologics. These molecules are used to treat same diseases as original molecules intended to. Like biosimilars, biosuperiors are also developed against already approved biological medicines but they possess attributes that are superior to the original molecules and not only replication. Biosuperiors are developed by utilizing revolutionary technologies including protein engineering, effector function enhancement, half-life extension through Fc engineering, bispecific molecules, antibody-drug conjugate technology and affinity maturation which enable biosuperiors with improved attributes over their innovator molecules.
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Developing a new biological medicine can incur cost up to USD 1.2 billion that is also associated with a high risk of research and development failure. However, the overall cost and research and development risk with biosimilars and biosuperiors are less than the original biologics. By some estimates, from development to approval, a biosimilar may incur cost up to USD 75 million to USD 250 million. On account of a requisite of lower investment many pharmaceutical and biopharmaceutical companies are striving to enter into biosimilars and biosuperiors market. One such example is Medlmmune, a business unit of AstraZeneca plc that has increased its investment in research and development programs related with biosuperiors with an intention to maintain a clinical pipeline portfolio with minimal risk. They consider biosimilars and biosuperiors, new drug categories with immense opportunities and expect to get higher return on little investment. This indicates a favorable condition for biosimilars and biosuperiors therapeutic antibodies market to grow. Advances in technology such as polyclonal mixtures, Fc engineering and antibody-drug conjugate also drive the market growth by escalating research and development activities.
The low price for biosimilars which usually costs in a range of 65%-75% of its original biological medicines is one of the key factors driving the demand for biosimilars worldwide. Biosimilars being cost effective alternative to innovator products also attract government and many payers, indicates a positive growth of the molecule.
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Patent expiry of many blockbuster biologics in coming years is expected to intensify the competition among biosimilar and biosuperiors manufacturers. It is estimated that by 2020, many biologics with sales worth of USD 81 billion are expected to lose their exclusivity. These biologics include Avastin (bevacizumab), Herceptin (trastuzumab), Synagis (palivizumab), Enbrel (etanercept), Humira (adalimimab), Remicade (infliximab) and Rituxan (rituximab). These patent expiries of major biologics are expected to offer potential opportunities in North America as well as Europe. In Asia-Pacific region, low cost of biosimilars and biosuperiors will play a key role in driving the market growth as reimbursement scenario in the region is very poor and patients have to pay for the drugs from their own pocket only. A large pool of patient with various chronic diseases including lung cancer and prostate cancer will further drive the market growth in Asia-Pacific region.
AstraZeneca plc, Eli Lilly and Company, Bristol-Myers Squibb, GlaxoSmithKline, Amgen, Inc., Novo Nordisk, Abbott Laboratories, Sanofi and Novartis AG are some major companies operating in the market for biosimilars and biosuperiors therapeutics antibodies.