2 research outputs found
Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America
Background: Developing countries have an estimate of ten times more
approved biosimilars than developed countries. This disparity demands
the need of an objective regulation that incorporates health policies
according to the technological and economical capabilities of each
country. One of the challenges lies on the establishment of
comparability principles based on a physicochemical and biological
characterization that should determine the extent of additional
non-clinical and clinical studies. This is particularly relevant for
licensed biosimilars in developing countries, which have an extensive
clinical experience since their approval as generics, in some cases
more than a decade. To exemplify the current status of biosimilars in
Mexico, a characterization exercise was conducted on licensed
filgrastim biosimilars using pharmacopeial and extended
characterization methodologies. Results: Most of the evaluated products
complied with the pharmacopeial criteria and showed comparability in
their Critical Quality Attributes (CQAs) towards the reference product.
These results were expected in accordance with their equivalent
performance during their licensing as generics. Accordingly, a rational
approval and registration renewal scheme for biosimilars is proposed,
that considers the proper identification of CQAs and its thoroughly
evaluation using selected techniques. Conclusions: This approach
provides support to diminish uncertainty of exhibiting different
pharmacological profiles and narrows or even avoids the necessity of
comparative clinical studies. Ultimately, this proposal is intended to
improve the accessibility to high quality biosimilars in Latin America
and other developing countries
Outcomes from elective colorectal cancer surgery during the SARSâCoVâ2 pandemic
Aim
This study aimed to describe the change in surgical practice and the impact of SARS-CoV-2 on mortality after surgical resection of colorectal cancer during the initial phases of the SARS-CoV-2 pandemic.
Method
This was an international cohort study of patients undergoing elective resection of colon or rectal cancer without preoperative suspicion of SARS-CoV-2. Centres entered data from their first recorded case of COVID-19 until 19 April 2020. The primary outcome was 30-day mortality. Secondary outcomes included anastomotic leak, postoperative SARS-CoV-2 and a comparison with prepandemic European Society of Coloproctology cohort data.
Results
From 2073 patients in 40 countries, 1.3% (27/2073) had a defunctioning stoma and 3.0% (63/2073) had an end stoma instead of an anastomosis only. Thirty-day mortality was 1.8% (38/2073), the incidence of postoperative SARS-CoV-2 was 3.8% (78/2073) and the anastomotic leak rate was 4.9% (86/1738). Mortality was lowest in patients without a leak or SARS-CoV-2 (14/1601, 0.9%) and highest in patients with both a leak and SARS-CoV-2 (5/13, 38.5%). Mortality was independently associated with anastomotic leak (adjusted odds ratio 6.01, 95% confidence interval 2.58â14.06), postoperative SARS-CoV-2 (16.90, 7.86â36.38), male sex (2.46, 1.01â5.93), age >70 years (2.87, 1.32â6.20) and advanced cancer stage (3.43, 1.16â10.21). Compared with prepandemic data, there were fewer anastomotic leaks (4.9% versus 7.7%) and an overall shorter length of stay (6 versus 7 days) but higher mortality (1.7% versus 1.1%).
Conclusion
Surgeons need to further mitigate against both SARS-CoV-2 and anastomotic leak when offering surgery during current and future COVID-19 waves based on patient, operative and organizational risks