Due to the increasing cost of drugs in clinical treatment in recent years, generic equivalents of brand-name drugs have been introduced in the global market to alleviate the problem. These drugs have the same bioequivalence as branded products. But what is the meaning of bioequivalence? The United States Food and Drug Administration (FDA) has defined it as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." Nowadays, the generic drugs account for more than 65% of the global pharmaceutical market. Because of the importance of generic drugs in healthcare, we must analyze the bioequivalence in the trials carefully.
Biosimilars are biomedical products that are almost identical to the original products produced by another company. Biosimilars must maintain consistent quality and clinical performance throughout their life cycle like the original products. Analysis of biosimilar trials has become very important due to possible issues such as safety, complexity, and variability. And our professional experts will provide you a comprehensive plan of biosimilar trial analysis.
Our Services
Our experts will help you to develop a clear and comprehensible plan to process the analysis of bioequivalence and biosimilar in the trials. The services that we can provide in the analysis of bioequivalence and biosimilar are as follows:For better analysis of bioequivalence, our experts will provide services from the following several aspects:
1. The treatment of data
Data processing is one of the most important aspects in the analysis of bioequivalence. The most common data processing involves analyzing variance using appropriate programs, such as SAS or WINNONLIN. They are good for examining the contributions from subject, period, formulation, and interactions between them. We will choose different analysis methods according to the characteristics of your experiment to help you perform bioequivalence analysis.
2. The using of endpoint for bioequivalence analysis
The FDA states that a pharmaceutical product is therapeutically equivalent to an innovative product if it is pharmaceutically equivalent, i.e., the same active ingredient, dosage form, strength and route of administration, and bioequivalence. Therapeutic equivalent products are used interchangeably. Thus, confirming the endpoint of bioequivalence becomes a significant thing. The FDA generally recommends the following endpoints for bioequivalence studies:
a. Pharmacokinetic endpointFor certain specialty drugs, endpoints for clinical trials could be different. Our experts will choose the proper endpoint according to the characteristics of different trials.
Following that, our bioequivalence analysis would provide you with a reasonable measure of the average bioequivalence between the drug's test and the reference formulation according to FDA standards. We use ‘two one-sided tests procedure’ to determine if average values for interested parameters (e.g. PK parameters) measured after giving the test and reference products are equivalent in the linear mixed-effects model.
We provide biosimilar trial analysis to assess the comparability of efficacy and safety between the proposed biosimilar and reference product throughout the process of the development and the manufacturing process for our clients. We conduct case-by-case assays for biosimilarity by assessing the following parameters:
a. Structural features and functions
The inherent structure and physicochemical heterogeneity of biopharmaceuticals as well as the complex manufacturing process may affect its safety and effectiveness. Thus, analyzing the physicochemical properties is very important. Our experts will choose various statistics methods to help you complete the statistics analysis of biosimilars’ structure and physicochemical heterogeneity.
b. Animal toxicity
c. Human pharmacokinetics (PK) and pharmacodynamics (PD)
d. Clinical immunogenicity
The primary safety concern for biosimilar agents is their potential immunogenicity. However, there is no single statistics method that can definitively predict the complex and various immunogenicity of a particular protein. Thus, we will face the problem of analyzing the immunogenicity in biosimilar trials. Our experts will choose the proper statistics method to help you complete the analysis of immunogenicity in biosimilar trial analysis.
e. Clinical safety and effectiveness
We guarantee the confidentiality and sensitivity of our customers' data. We are committed to providing you timely and high-quality deliverables. At the same time, we guarantee cost-effective, complete and concise reports.If you are unable to find the specific service you are looking for, please feel free to contact us.
References:
1. Schellekens H. (2009) ‘Biosimilar therapeutics—what do we need to consider’, Ndt Plus, 2(1), 27. 2. Epstein M S, Ehrenpreis E D, Kulkarni P M. (2014) ‘Biosimilars: the need, the challenge, the future: the FDA perspective’, American Journal of Gastroenterology, 109(12), 1856. 3. Midha K K, Mckay G. (2009) ‘Bioequivalence; Its History, Practice, and Future’, Aaps Journal, 11(4), 664. 4. Midha, K. K., & McKay, G. (2009) ‘Bioequivalence; Its History, Practice, and Future’, The AAPS Journal, 11(4). 5. Birkett, D. J. (2003) ‘Generics-equal or not’, Australian Prescriber, 26(4), 85-7. 6. US Food and Drug Administration. (2003) ‘Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products—general considerations’, US Food and Drug Administration, Washington, DC. 7. Dranitsaris, G., Dorward, K., Hatzimichael, E., & Amir, E. (2013) ‘Clinical trial design in biosimilar drug development’, Investigational new drugs, 31(2), 479-487. 8. US Food and Drug Administration. (2012) ‘Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product’, US Food and Drug Administration, Washington, DC.