Biosimilars/General
Interchangeable insulin glargine biosimilar preferred on Express Scripts
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.
Argentinian gastroenterologist groups issued position statement on biosimilars use
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].
Potential biotech collaboration between India and Colombia
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 approving more copy biologicals since new guidelines introduced
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.
New Zealand to expand access to rituximab, possibly adalimumab
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.
Off-patent biologicals/Biomimics approved in Bolivia
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).
Interactive map for interchangeable biosimilars
US-based healthcare services company Cardinal Health has launched an interactive map for interchangeable biosimilars as part of its information for biosimilars.
Biosimilars, innovation in the treatment of chronic disease
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.
Biosimilars of insulin aspart
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.
Biosimilars applications under review by EMA – July 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.
