In India, guidelines for biosimilars provide comprehensive coverage of physicochemical and biological characteristics, but they are less strict than FDA/EMA/WHO requirements [34], and only short trials are required to assess bioequivalence for licensing procedures [14]. The latest guidelines state that...
The US Food and Drug Administration (FDA) requires a similar stringent biosimilar development process.The etanercept biosimilar SB4 (Benepali), recently approved for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial ...
seven biosimilars have been approved by the United States Food and Drug Administration(FDA)for use in Crohn's disease,ulcerative colitis,and colorectal cancer.There are other biologics involved in treating gastroenterologic diseases for which there are no FDA approved biosimilars.Although biosimilars ...
Infliximab approved for use in Crohn’s disease: a report on the FDA GI Advisory Committee conference. Inflamm. Bowel Dis. 4, 328–329 (1998). Article CAS PubMed Google Scholar Morrow, T. & Felcone, L. H. Defining the difference: what makes biologics unique. Biotechnol. Healthc. 1,...
due mainly to an increase in expenditure on biopharmaceuticals. Iran’s policymakers believe that although biosimilars are a cost-effective intervention for the treatment of patients, the regulatory approaches for their marketing used by organizations such as EMA, FDA or even WHO may not suit the ne...
Out of several safety issues related to biosimilars, two main safety concerns are variable potency and immunogenicity, for which a robust long-term pharmacovigilance system is needed. Various guidelines have been issued for the regulatory approval and pharmacovigilance of biosimilars by USFDA, EU, and...
As described in Sect.1, biosimilars continue to gain more traction in the biopharmaceutical market. The FDA approved the first biosimilar in 2015 and since has approved a total of 16 biosimilars (three in 2016, five in 2017, and seven in 2018) [9,49]. Concurrently, the relationship between...
This fact might serve as an advantage of panitumumab over cetuximab, since both drugs are FDA approved for metastatic CRC. Both antibodies show ef- ficacy in chemotherapy-naive patients as well as in patients whose tumors are refractory to chemotherapy by improving the ORR. When combined with ...