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Biosimilars/General

MD002152

AMD position statement on the use of biocomparables for psoriasis

Biosimilars/General | Posted 19/11/2021

The Mexican Academy of Dermatology (AMD) is a non-profit civil association founded in 1952 and formed by a group of relevant dermatologists dedicated to sharing experiences and keeping up to date with the latest advances in research. This group has developed the following position statement on biosimilars for psoriasis.

19 AA010921

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]. 

ANAMED V21K19LT

Biosimilars approved in Chile

Biosimilars/General | Posted 19/11/2021

In Chile, the regulatory body responsible for the approval of biological medicines is the National Drug Agency (Agencia Nacional de Medicamentos, ANAMED), which is part of the Institute of Public Health of Chile (ISP), under the Ministry of Health.

DINAVISA V21J15LT

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).

CECMED V21J07LT

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).

DIGEMID V21J01

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].

Salud Uruguay V21I24MN

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).

MinSalud Costa Rica V21I03

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.

48 MD002137

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.

IBD 3

Argentinian gastroenterologist groups issued position statement on biosimilars use

Biosimilars/General | Posted 22/10/2021

Experts from the steering committees of the Argentinian Society of Gastroenterology (SAGE), the Argentinian Federation of Gastroenterology (FAGE) and the Argentinian Group of Crohn's Disease and Ulcerative Colitis (GADECCU) have issued a joint position regarding the practical conditions for the clinical use of biosimilars indicated for inflammatory bowel diseases (IBDs), by discussing the most notable aspects related to the definition of a biosimilar drug, bio-similarity, non-comparable biological drugs or ‘intended copies’, approval requirements, extrapolation of indications, interchangeability, automatic substitution, non-medical switching, nomenclature, clinical standards regarding safety and efficacy, implementation of an efficient and appropriate pharmacovigilance system and the potential economic impact on the healthcare system [1].

Shaking hands V13D29

Potential biotech collaboration between India and Colombia

Biosimilars/General | Posted 15/10/2021

A letter of intent on cooperation in biotechnology has been signed between India and Colombia, which could include collaborations on vaccines, biosimilars, and medical devices.

China CFDA NMPA

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.

Clinical Trials 2 V13K29

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.

AGEMED V21I17MN

Off-patent biologicals/Biomimics approved in Bolivia

Biosimilars/General | Posted 17/09/2021

In Bolivia, the regulatory body for the approval of biologicals is the State Agency for Medicines and Health Technologies AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud).

US map V18D13

Interactive map for interchangeable biosimilars

Biosimilars/General | Posted 10/09/2021

US-based healthcare services company Cardinal Health has launched an interactive map for interchangeable biosimilars as part of its information for biosimilars.

Health Budget 3

Biosimilars, innovation in the treatment of chronic disease

Biosimilars/General | Posted 27/08/2021

Biological therapies have meant a significant advance in the way of treating various chronic conditions such as cancer, rheumatoid arthritis, multiple sclerosis. However, they have brought with them high costs for health systems that have been channelled through supply programmes of this type of drugs, in the case of the Dominican Republic, through the High Cost Medicines Programme.

Insulin Aspart Structural Formula V21H27

Biosimilars of insulin aspart

Biosimilars/General | Posted 27/08/2021

Last update: 27 August 2021

Insulin aspart is a type of manufactured insulin used to treat type 1 and type 2 diabetes. It has a more rapid onset and a shorter duration of activity than normal human insulins.

EMA logo 1 V13C15

Biosimilars applications under review by EMA – July 2021

Biosimilars/General | Posted 30/07/2021

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Switching mAb Pfizer V18K30

Quebec announces biosimilar switching policy

Biosimilars/General | Posted 30/07/2021

Quebec, Canada has announced a biosimilar switching policy, which is expected to generate annual savings of CA$100 million at its conclusion in 2022.

NBCD 1 V13J25

Biosimilars as a sustainable alternative for complex diseases

Biosimilars/General | Posted 23/07/2021

The use of ‘similar biotherapeutic’ products and ‘biocomparable’ medicines, as biosimilar medicines are named in Colombia and Mexico, respectively, offer a sustainable alternative for health systems, leading to significant savings for payers and health institutions, as well as market opening. Biosimilars thus provide a fair competitive solution.