Biosimilars are a class of pharmaceutical drug products that are similar to a currently licensed FDA biological product. Biosimilars can be more advantageous to both producers and consumers alike because they can be cheaper to produce. Biosimilar drugs differ from FDA-licensed drugs when comparing the chemical composition between the two. Differences in chemical composition is only one part of categorizing a biosimilar; the other part is that there can’t be any meaningful difference between the two from a clinical standpoint. Generics are often used over their brand-name counterpart because of cost, but with that comes the lengthy amount of time between a FDA-licensed drug first becoming available and a generic reaching the public because of patent laws. The benefit of biosimilars is they perform the same, if not better compared to current FDA-licensed drugs while getting around the infringement problems generics have to wait for.
Creating generic, small-molecule drugs is simple as there is a general recipe to follow. Biosimilars are much more difficult because they are sensitive to the manufacturing processes due to the challenges of using live cells, and many of the production details are highly-guarded so creating imitations is difficult.
Contract Laboratory has helped the following requestors find laboratories for their testing:
- FDA GMP Midwest USA Pharmaceutical Packaging Laboratory needed for FDA Container Integrity Testing: CCI Testing either Dye Immersion or Container Closure Integrity Test Bacterial of 1mL, and 3ml glass vial; 1mL glass vial w/27G needle. Type of product: biosimilar parenteral drugs
- OECD GLP Bioaalytical Preclinical Laboratory needed for pharmaceutical preclinical plasma testing: Analysis of , B2M, neopterin, 2’5′-OAS and ADA, biosimilar INF-alfa in blood plasma samples (human and animal samples). Validation according EMA guidelines.
- Non-GLP, Non-GMP preclincial laboratory needed for mouse safety study for GCSF Biosimilar. 5 mice get 0,5 ml of rhGCSF and beeing observed over a period of 7 days, body weight is taken 3xweekly, clinical observation daily, mortality daily, after the test period the mice should survive and gain weight
- view these test requests and others, here!
If your company or organization is in need of a laboratory to perform scientific research or testing of biosimilars, call us at 1-855-377-6821 or submit a biosimilars test request on our website!
Originally posted 2016-12-15 17:15:43.