File Name: biosimilars and interchangeable biologics tactical elements .zip
Sarfaraz K. Niazi, PhD, is the founding executive chairman of Therapeutic Proteins International LLC, a world-class pure-play developer and manufacturer of biosimilar and interchangeable recombinant biologics, headquartered in Chicago.
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As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U. Competition in the heavily regulated marketplace for these blockbuster therapeutics is expected to substantially impact the pharmaceutical industry and national health systems. To date, the U. Ten of the authorizations have been withdrawn post-approval Table 1. There are eleven other approved adalimumab biosimilars and seven other approved pegfilgrastim biosimilars. The U. Given that the first U.
Hiten Gutka PhD. Gutka worked at Biocon, USV and Reliance Biopharmaceuticals in India, on analytical and pharmaceutical development of biosimilar Insulins and other biosimilars including cytokines and hormones. He serves on the editorial board of the journal mAbs. Harry Yang, Ph. He has participated in industry initiatives related to Quality by Design, analytical method development and validation, and sterile drug product bioburden testing. He has 23 years of experience in drug discovery, pre-clinical and clinical study design and analysis, translational sciences, biopharmaceutical development, manufacturing, and regulatory submissions.
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