WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.

The WHO informal consultation was held to promote the revision of WHO guidelines on evaluation of similar biotherapeutic products (SBPs) adopted by the Expert Committee on Biological Standardization (ECBS) in 2009. It was agreed in the past consultations that the evaluation principles in the guidelines are still valid, but a review was recommended to provide more clarity and case-by-case flexibility. The opportunity was therefore taken to review the experience and identify areas where the current guidance could be more permissive without compromising its basic principles, and where additional explanation could be provided regarding the possibility of reducing the amount of data needed for regulatory approval. The meeting participants applauded the leading role taken by the WHO in providing a much-needed streamlined approach for development and evaluation of SBPs which will provide efficient and cost-effective product development and increase patient access to treatments. It was recognized that the principles as currently described in the draft WHO guidelines are based on sound science and experience gained over the last fifteen years of biosimilar approvals. However, since these guidelines when finalised will constitute the global standard for biosimilar evaluation and assist national regulatory authorities in establishing revised guidance and regulatory practice in this complex area, it was felt that further revision and clarity on certain perspectives in specific areas was necessary to dispel uncertainties arising in the current revised version. This report describes the principles in the draft guidelines, including topics discussed and consensus reached.

[Dose curves for radiation-induced cytogenetic damage in human lymphocytes]. / O forme dozovykh krivykh radiatsionno indutsirovannykh tsitogeneticheskikh povrezhdenii limfotsitov cheloveka.

Insufficient fitness of experimental data with convenient linear and linear-quadratic models of "dose-effect" dependence for the number of chromosome aberrations of different types were revealed. Proposed method of approximation of the experimental "dose-effect" dependence with piece-linear splines allows to obtain more accurate results in the most cases and therefore is more preferable than the linear and linear-quadratic models.

[Removal of biologically active admixtures from immunoglobulin preparations]. / Udalenie biologicheski aktivnykh primesei iz preparatov immunoglobulinov.

Inclusion of an additional treatment of the products obtained at centrifugation stages b1 and b13 with activated bentonite and aluminium hydroxide into the alcohol method for the production of immunoglobulin from placental and abortion blood permits obtaining preparations with lowered content of proteolytic enzymes and thermostable acid phosphatase, free from chorionic gonadotropin and blood pigment. The treatment of the final preparation with DEAE cellulose removes blood group antigens from immunoglobulins. The preparations obtained by this method have been shown to meet the requirements for immunoglobulins imposed by technological specifications.