Biotech products are often credited as the engine of innovation in the pharmaceutical industry. They generate drug discoveries by maintaining a narrow focus on the latest knowledge in the life sciences and are dedicated to mastering leading-edge technology.
Biosimilars are biologic medical product which is almost an identical copy of an original product that is manufactured by a different company.Biosimilars are officially approved versions of original "innovator" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. Unlike with generic drugs of the more common small-molecule type, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance, although they do have access to the commercialized innovator product.
The use of biomarkers in clinical research has become so commonplace that their presence as primary endpoints in clinical trials is now accepted almost without question. In the case of specific biomarkers that have been well characterized and repeatedly shown to correctly predict relevant clinical outcomes across a variety of treatments and populations, this use is entirely justified and appropriate.There has long been broad consensus that clinical endpoints are the primary, and to some the only relevant, endpoints of all clinical research, and ultimately of all biomedical research.
Quest life sciences aid biotechnology industry so that biotech products will be introduced with high quality and affordable prices.