Biopharmaceutical is one of the fastest growing industries with addition of numerous biologics that provide novel treatment modalities for life-threatening and rare diseases. Biologics are produced from living organisms through unique manufacturing and purification processes. It includes a wide variety of products such as vaccines, blood, blood components, cells, allergens, genes, tissues, and recombinant proteins that are derived from human, animal or microorganisms by using biotechnological procedures. Some examples for biosimilars include Lantus (insulin glargine), Humira (adalimumab), Herceptin (trastuzumab), Avastin (bevacizumab), and Botox (onabotulinumtoxina).
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The process of developing a biosimilar is a challenging and meticulous task. Comprehensive physiochemical and biological characterization studies are conducted to determine similarity of biologics with an originator referenced product. Bioequivalence of the biosimilar and innovator products must also be acquired by conducting extensive pre-clinical and clinical trials. Since recent past, leading pharmaceutical companies are engaged in developing biosimilars due to advantages offered by it and patent expiry of biological products, which presents lucrative opportunity to biopharmaceutical companies. Biologics have potential to revolutionize conventional treatment for diseases such as cancer, delay or reverse the course of immune related conditions, and improve treatment procedure for rare diseases.
In the U.S., biological manufacturers are granted a 12-year exclusivity period to encourage research and development of new biologics and allow recovery of research and development costs. The Center for Biologics Evaluation and Research (CBER) within Food and Drug Administration (FDA) regulates approval of biological products. The Food and Drug Administration (FDA) recommends to conduct stepwise approach to analyze similarities of the proposed biosimilar and its reference product in regards to structure, function, animal toxicity, pharmacokinetic (PK) and pharmacodynamic (PD) properties as well as their chemical safety, purity, and efficacy profiles.
Biopharmaceutical companies looking forward to enter biosimilars industry can benefit from PHASE-XS, as it provides detailed differentiation among drugs currently in pipeline. The data can be used to develop proactive marketing strategy to achieve both therapeutic and economic benefits.
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