Protein biosimilars: Opportunities and challenges

Abstract

Introduction Therapeutic proteins are next-gen- eration drugs in the prevention and treatment of diseases, in particular human critical illness. The expira- tion of patents in the originally ap- proved biopharmaceutics has stim- ulated a great excitement and the subsequent development of “follow- on” versions of these first-in-line biotherapeutic products, known as “Biosimilars” or “Biobetters”. Bio- similars are a new class of drugs intended to offer comparable safety and efficacy (or clinical equiva- lence) 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 manufactur- ing processes and their potential risks for increased immunogenic- ity. Therefore, specific regulatory approval pathways and guidelines must be followed when creating Bio- similars. This article reviews the re- quirements and key considerations for producing Biosimilar agents as well as the important Biosimilar guidelines/regulations from differ- ent countries including the World * Corresponding authors Emails: mingyuehe2001@yahoo.com; drcarledwards@gmail.com 1 Laboratory of Recombinant Protein Thera- peutics, Chengdu Institute of Biological Prod- ucts, Chengdu 610041, PR China 2 Department of Dermatology, University of Colorado at Denver, Anschutz, Medical Cen- tre, Aurora, CO 80025, USA 3 National Key Laboratory of Biotherapy and Cancer Research, Western Sichuan China Med- ical School and Hospital, Sichuan University, Chengdu, Sichuan Province 610041, PR China Health Organization, Food and Drug Administration and the European Medicines Agency. Conclusion Patents that expired or are soon to expire have provided a great oppor- tunity for companies to make copies or ‘generic’ versions of these drugs. Despite some challenges, therapeutic development of lower cost Biosimi- lars 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.