To find new treatments to combat diseases such as Cancer numerous investigations have been carried out and one of them has found that biotech drugs offer a wider range of possibilities to treat this disease.
This type of biotech drugs or biocomparable are obtained through living cells and classified as similar or din clinical differences in safety, purity, potency and effectiveness with respect to the biological reference medicine, without being identical.
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According to Dr. Max Saráchaga, medical director of the Amgen Mexico company, to commemorate 40 years of this biotechnology company, the approach to the development of biocomparable drugs begins with the use of tools such as human genetics advanced to unravel the complexities of disease and understand the fundamentals of human biology.
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While generics require approximately 50 quality control tests as part of the manufacturing process, biotech and biocomparable products may require approximately 250 tests to ensure they meet all necessary quality criteria. biocomparability it must be proven with specific clinical studies for each product.
“Sufficient clinical and pharmacological evidence is collected to understand the structure and function of the reference molecule and thus develop these drugs with the highest quality, ensuring that they comply with the regulatory standards indicated in each country,” said Dr. Saráchaga.
“Due to our experience and reputation in the development and production of complex biotechnological drugs, we are in the position to guarantee confidence in our biocomparables, which can offer additional treatment options for serious health conditions in Mexicans,” he added.
A pioneer in biotechnology since 1980, Amgen has grown into one of the world’s leading independent biotechnology companies.
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