A Clinical Review of Biosimilars Approved in Oncology
Objective: To summarize and review the clinical data from the Food and Drug Administration (FDA) biosimilars approved for use in the treatment of cancer and the challenges of health care institutions in the face when implementing a new biosimilar approved. Data Sources: A literature search of the following databases conducted between January 1st 2012 and December 31st 2019: PubMed, Google, and ClinicalTrials.gov. The search terms including biosimilar words, bevacizumab, rituximab, and / or trastuzumab.
Study Selection and Data Extraction: Only the main literature on biosimilars with ongoing or completed phase 3 trials and / or FDA approval included in the final analysis. primary literature consists of peer-reviewed publications, abstracts published, and any results are posted on ClinicalTrials.gov database.
Data Synthesis: Clinical trials of biosimilars approved by the FDA for bevacizumab, rituximab, and trastuzumab showed no significant difference to the efficacy, safety, and pharmacokinetics when compared with their reference products. Relevance to Patient Care and Clinical Practice: biological anticipated growth in oncology and the recent introduction of biosimilars over the past few years has put a lot of emphasis on biosimilars as a significant source of cost savings for the health care system. We compile articles and analysis of data on the efficacy of a biosimilar, safety, and the existing financial impact.
Conclusion: The main concerns revolve biosimilars their long-term efficacy and safety. Even with a lot of questions to be answered, biosimilars have the potential for significant cost savings in the US health care system.
Orty New Zealand albino rabbits were recruited for the study and were divided into four groups to be sacrificed at 48 hours, one, two, and four weeks after injection. In each group, five rabbits received the 0.05 mL (2 mg) aflibercept biosimilar in the right eye and 0.05 mL of saline in the left eye as a control, and in the same manner, the remaining five rabbits received a reference drug in the right eye and salt in the left eye.
Explaining biosimilars and how reverse engineering plays an important role in their development
Introduction: Biologicals is a protein-based therapy that consists of a structure larger and more complex than small molecule drugs. As a patent for the originator biologic therapy ended, biosimilar products are licensed for the same indications as the reference biologic they are marketed throughout the different specialties. Due to the complex nature of the manufacturing process for the biological therapy compared with chemically synthesized drugs Conventionally, the development of biosimilars is more complicated and expensive than the manufacture of small molecule generics.
Areas covered: The manufacturing process of biological originator in many cases largely unknown biosimilar developers and for reverse engineering through extensive analysis of the originator is a fundamental and important step for successful biosimilar development. In this review, the authors examined the abbreviated roadmap for biosimilar approvals that must be supported by the same strict standards that apply to all biological drugs. They discussed various aspects of biosimilar manufacturing with a focus on reverse engineering.
expert opinion: biosimilar approval pathway placing greater emphasis on the preclinical assessment compared to the originator biological development. Several comparative clinical studies add little to confirm the efficacy of the molecule under study while adding much to the cost and time to bring a biosimilar into clinical use. A successful demonstration of biosimilarity to a reference product is therefore essential to the structural and functional level but this can not be achieved without a well-designed and quality driven reverse engineering of the production process of the originator.