Biosimilars/General

Interchangeable insulin glargine biosimilar preferred on Express Scripts

Biosimilars/General | Posted 05/11/2021

The interchangeable insulin glargine biosimilar, Semglee, has been listed by Express Scripts, America’s largest pharmacy benefit management organization, as a preferred insulin brand on its National Preferred Formulary (NPF), which includes more than 28 million lives in the US.

Advances for biotech in Korea: Samsung Bioepis, Celltrion and LG Chem

Biosimilars/General | Posted 12/11/2021

Korean companies Samsung Bioepis and Celltrion have accelerated their penetration into the global market, with a total of 11 approvals in Europe and eight in the US. In addition, Korea’s LG Chem has expanded its presence in Japan and China. This growth follows increasing investment in the biotech sector from South Korea’s government and private pharmaceutical companies [1, 2]. 

Biosimilars approved in Paraguay

Biosimilars/General | Posted 15/10/2021

In Paraguay, the regulatory body responsible for the approval of biological drugs is the National Directorate for Sanitary Surveillance (Dirección Nacional de Vigilancia Sanitaria, DINAVISA).

Biosimilars approved in Brazil

Biosimilars/General | Posted 14/01/2022

In Brazil, the regulatory body for the approval of biologicals is the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA), which is linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.

Biosimilars approved in Cuba

Biosimilars/General | Posted 08/10/2021

In Cuba, the regulatory body responsible for approving biological drugs is the Center for the State Control of Medicines, Medical Equipments and Devices (Control Estatal de Medicamentos, Equipos y Dispositivos Médicos, CECMED).

China approving more copy biologicals since new guidelines introduced

Biosimilars/General | Posted 08/10/2021

China has approved many more copy biologicals in the last three years. A move which, according to Pharmaceutical Technology, is thought could be due to the introduction of new guidelines for the products.

Biosimilars approved in Peru

Biosimilars/General | Posted 01/10/2021

In Peru, the regulatory body responsible for approving biological drugs is the General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Peruvian Ministry of Health (MINSA) which is in charge of leading the National and Decentralised Health System, the policy for the universal health assurance and the policies and intersectoral actions on social determinants [1].

New Zealand to expand access to rituximab, possibly adalimumab

Biosimilars/General | Posted 01/10/2021

New Zealand’s Pharmaceutical Management Agency, Pharmac, has announced a decision to expand access to rituximab and has launched a proposal to expand access to adalimumab.

Biosimilars approved in Costa Rica

Biosimilars/General | Posted 03/09/2021

In Costa Rica, the regulatory body responsible for the approval of biologicals is the Ministry of Health.

Biosimilars approved in Uruguay

Biosimilars/General | Posted 24/09/2021

In Uruguay, the regulatory body responsible for the approval of biologicals is the Ministry of Public Health of Uruguay (Ministerio de Salud Pública de Uruguay, MSP).