Biosimilars
Iran approves its first rituximab biogeneric
In May 2015, Iran’s National Regulatory Authority, the Food and Drug Organization (FDO), approved its first rituximab biogeneric (Zytux). The medicine received its marketing authorization based on the previously published national guideline for marketing of biogenerics in Iran [1].
Biosimilar filgrastim highly similar to originator filgrastim
A study comparing Sandoz’s filgrastim biosimilar (Zarzio) with originator filgrastim (Neupogen) has shown that they are highly similar in terms of their structure and function [1].
Clinical trials of biosimilars for psoriasis treatment
Tumour necrosis factor-alpha (TNF-alpha) is a cytokine, or protein, that prompts the body to create inflammation. In psoriasis and psoriatic arthritis, there is excess production of TNF-alpha in the skin or joints. Therefore, drugs that block TNF-alpha, such as Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab) and Stelara (ustekinumab), can be used to treat psoriasis and psoriatic arthritis.
Biosimilars Forum launched
A group of biosimilars developers in the US announced on 5 May 2015 the launch of a joint initiative to promote biosimilars in the form of the Biosimilars Forum.
Venezuelan approval for Celltrion’s Remsima
Celltrion announced on 29 April 2015 that it had received approval for its infliximab bioterapéuticos similares from the Venezuelan medicines agency, the Instituto Nacional de Higiene ‘Rafael Rangel’ (INHRR National ‘Rafael Rangel’ Institute of Hygiene).
Brazil approves first monoclonal antibody follow-on biological
Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 27 April 2015 that it had approved its first follow-on biological medicine through ‘the development by comparability’.
Considerations when promoting generics prescribing in the US
Sarpatwari and co-authors investigate the legal and ethical consideration for promoting generics prescribing in the US and how this might apply to biosimilars [1].
Australian guide to biosimilars
Australia’s Generic Medicines Industry Association (GMiA) has launched a Guide to Biosimilars. The guide is designed to provide a concise, ‘user-friendly’ reference on the subject for patients, clinicians, pharmacists, politicians and policymakers.
Adalimumab biosimilar meets primary endpoints in phase I study
US biotech company Oncobiologics announced on 12 February 2015 that ONS-3010, its adalimumab biosimilar candidate, met the primary endpoints in its first clinical study.
WHO receives positive feedback on BQ for biologicals
According to the World Health Organization’s executive summary of its 59th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances, almost half of comments on its proposed biological qualifier (BQ) for naming biologicals were positive.
