In this issue, we explore key considerations for biosimilar clinical pharmacology studies. Biosimilars are usually given the same indications as the originator drugs but with reduced development cost, which translates to a lower market price, making them more accessible and affordable to patients.
Click here to download a readable, PDF version of Issue 4: https://www.altasciences.com/sites/default/files/2020-02/The%20Altascientist_issue4_Biosimilars_2020.pdf
Issue 4 was originally published in print in September 2018.
CHAPTERS:
- 0:20 — Section 1: The Rise of the Biosimilar Market
- 3:36 — Section 2: Regulatory Landscape
- 8:04 — Section 3: Altasciences Puts Biosimilars to the Test
- 12:41 — Section 4: Experts in Bioanalysis
- 16:32 — Section 5: Key Considerations
- 23:30 — Section 6: Ensuring the Continued Success of Biosimilar Programs
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.