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Developing biosimilars is not as simple as copy and paste

Biosimilars are essentially copies of an original biologic or reference drug created in an effort to provide patients with more accessible, more affordable medications for a variety of diseases. Several years ago, many antibody drug agents (ADAs), specifically monoclonal antibodies, were developed to target diseases such as autoimmune disorders or cancer. These well-known biopharmaceuticals became highly respected therapies but in recent years, the patents on these drugs have expired opening up a world of opportunity for the biosimilar market to blossom. According to Lie and colleagues (2015) from Guy’s and St Thomas NHS Foundation Trust in London, “the rheumatology field has adopted routine use of biologics including monoclonal antibodies, and it is therefore a desirable market for biosimilar research. Indeed, conducting a search with the search phrase “biosimilar” on revealed almost 50% of the on-going trials were related to Rheumatology, reflecting the propensity of expansion for biosimilar research in the Rheumatological field. Many large pharmaceutical companies have realized the potential in the biosimilar market and more and more researchers are devoting their pipelines to the development of biologic.” In fact, it was predicted that by 2016, ten of the 20 top-selling drugs will be biologics as opposed to synthetically produced small molecules and three of those top 10 drugs (Adalimumab, Rituximab, Infliximab) will be monoclonal antibodies (McCamish et al., 2011).

Manufacturing biosimilars is a complicated process in which proving efficacy while ensuring safety of the patient can be quite challenging, due to their ability to interact with endogenous proteins which can trigger unwanted physiological responses in patients. Given their large size and rotation, antibodies generally exhibit complex three-dimensional conformations making it difficult to obtain exact biologic comparability to their reference drugs. In addition, even slight changes in manufacturing procedures such as dosages, buffer formulations, shipping/packaging conditions or handling can alter biosimilar behavior in the human body. With so many factors to consider when developing biosimilars, the EMA (European Medicines Agency) and the FDA (Food and Drug Administration) have implemented guidelines for the development of these therapies. The EMA and the FDA both strive to offer researchers safety considerations and goals that need to be considered and adhered to during biosimilar development. The criteria established by these organizations need to be met before a biosimilar can be considered for release to market in Europe or the United States. Biosimilars cannot show any clinically meaningful differences when compared to the reference drug from which that biosimilar is being modeled. Pre-clinical studies, clinical studies, immunogenicity assessment, and pharmacovigilance for monitoring biosimilar safety are all vital steps in responsible biosimilar drug development (Reinisch et al., 2015). In an effort to aid researchers in this complex journey of biosimilar discovery, Enzo Life Sciences has introduced a line of products that are designed to help. Our BIOLIKE™ kits include a panel of antibodies against a target biologic monoclonal antibody to which the potential biosimilar structure can be compared allowing for detection of conformational changes that could affect efficacy and safety. The assay uses more than 30 polyclonal antibodies to cover an entire mAb, thereby measuring its surface-epitope distribution systematically and sensitively, providing a unique measurement of biosimilar monoclonal antibody higher-order structure comparability.

Enzo Life Sciences offers BIOLIKE™ kits, which include many of the commonly used reference drugs for biosimilar development (Adalimumab, Alemtuzumab, Bevacizumab, Cetuximab, Infliximab, Palivizumab, Rituximab, Trastuzumab) as well as a kit designed to look at conserved monoclonal sequence confirmation for the research of novel biosimilar monoclonal antibody therapies. All of our kits are designed to assist researchers with the production of safe and efficient biosimilars which could be used for the treatment of a variety of diseases. You can find below a complete list of our BIOLIKE™ Conformational ELISA kits.

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  1. G. Lie, et al. Biosimilar vs biological agents in rheumatology: When are biosimilar agents similar enough? Int. Immunopharmacol. (2015) 27:220.
  2. M. McCamish, et al. Worldwide experience with biosimilar development. MABs (2011) 3:209.
  3. W. Reinisch, et al. Biosimilar safety factors in clinical practice. Semin. Arthritis Rheum. (2015) 44:S9.

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