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Introduction Therapeutic proteins are next-generation drugs in the prevention and treatment of diseases, in particular human critical illness. The expiration of patents in the originally approved biopharmaceutics has stimulated a great excitement and the subsequent development of “followon” versions of these first-in-line biotherapeutic products, known as “Biosimilars” or “Biobetters”. Biosimilars are a new class of drugs intended to offer comparable safety and efficacy (or clinical equivalence) to their original reference products which are brand name drugs and no longer under patent coverage. However, preparing exact copies of biologicals is much more challenging than replicating small molecules due to their structural complexity, intricate manufacturing processes and their potential risks for increased immunogenicity. Therefore, specific regulatory approval pathways and guidelines must be followed when creating Biosimilars. This article reviews the requirements and key considerations for producing Biosimilar agents as well as the important Biosimilar guidelines/regulations from different countries including the World Health Organization, Food and Drug Administration and the European Medicines Agency. Conclusion Patents that expired or are soon to expire have provided a great opportunity for companies to make copies or ‘generic’ versions of these drugs. Despite some challenges, therapeutic development of lower cost Biosimilars will inevitably enter the drug market in the near future, increasing the market competition and patients’ access to the more cost-effective therapies that they may not have otherwise. Introduction The continuous clinical and commercial success of biologics such as monoclonal antibodies (mAb) and recombinant versions of endogenous proteins is transforming the pharmaceutical industry. Protein drugs have been demonstrated to significantly alter and even possibly “cure” some human critical illness where synthetic small molecule agents have failed1. In 2010, worldwide sales of all biologics approached nearly the $100 billion mark in 20122 and it is expected that more than 50% of new drug approvals will be biologics3 by 2015, rising to more than 70% by 20254. As these drugs begin to come off patent, substantial opportunities exist for other companies to make copies or ‘generic’ versions of these drugs, now commonly known as “Biosimilars” or “Biobetters”. As of the end of 2012, there are a total of 17 Biosimilar and/or Biobetter recombinant protein therapeutics on the market in Europe alone (Table 1). However, the introduction of follow-on versions of biological products is much more difficult than for small molecules. Many biologicals such as mAb and recombinant therapeutic proteins are much larger and more complex, the extent to which * Corresponding authors Emails: mingyuehe2001@yahoo.com; drcarledwards@gmail.com 1 Laboratory of Recombinant Protein Therapeutics, Chengdu Institute of Biological Products, Chengdu 610041, PR China 2 Department of Dermatology, University of Colorado at Denver, Anschutz, Medical Centre, Aurora, CO 80025, USA 3 National Key Laboratory of Biotherapy and Cancer Research, Western Sichuan China Medical School and Hospital, Sichuan University, Chengdu, Sichuan Province 610041, PR China Table 1 Biosimilar approved in Europe Branded product Biosimilar manufacturer |
