Biosimilars/General
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.
Quebec announces biosimilar switching policy
Quebec, Canada has announced a biosimilar switching policy, which is expected to generate annual savings of CA$100 million at its conclusion in 2022.
Biosimilars as a sustainable alternative for complex diseases
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.
PANLAR issues consensus statement on biosimilars
PANLAR presented its position on biosimilar medicines at its own congress in Argentina. Via the consensus statement, the PANLAR specialists seek to demonstrate the efficacy, pharmacovigilance, regulation, quality and safety of biosimilar medicines.
Biosimilar pipelines for South Korean firms: LG Chem and GC Pharma
Biosimilar makers from South Korea are making their mark, not only in South Korea, but around the world when it comes to biosimilars. Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture) are already becoming major players in the world of biosimilars. While, other Korean companies, such as LG Chem Life Sciences (LG Chem) and GC Pharma (formerly Green Cross) are also expanding their biosimilar pipelines.
US biosimilars information guides and support for cancer biosimilars
Pharmaceutical giant, Pfizer, and the Cancer Support Community, in the US, have published guides to biosimilars. In addition, Pfizer is collaborating with The National Comprehensive Cancer Network® (NCCN®) to fund projects to support innovation related to appropriate biosimilar adoption in oncology.
