Biosimilars/General

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.

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.

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.

PANLAR issues consensus statement on biosimilars

Biosimilars/General | Posted 16/07/2021

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

Biosimilars/General | Posted 09/07/2021

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

Biosimilars/General | Posted 02/07/2021

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.

Biobadamérica promotes the use of biological and biosimilar drugs in Latin America

Biosimilars/General | Posted 25/06/2021

In 2007, the Spanish Society of Rheumatology (Sociedad Española de Reumatología, SER) created the Biobadamérica, an international collaborative project to promote the implementation of national safety registries for the use of biological and biosimilar drugs in Latin American countries [1].

The role of the patient in treatments with biosimilars in Argentina

Biosimilars/General | Posted 21/06/2021

This is how Dr Eduardo Mysler, Medical Director for the Research Medical Organization (OMI) and rheumatology specialist with a long research career reflects that ‘patients have to understand all the details of their disease’.

US Supreme Court rejects Enbrel patent challenge from Sandoz

Biosimilars/General | Posted 11/06/2021

The US Supreme Court has declined to review a patent challenge from Sandoz on Amgen’s blockbuster anti-inflammatory, Enbrel (etanercept). This means Sandoz will not be able to launch its etanercept biosimilar, Erelzi (etanercept-szzs), on the US market until 2029.

Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis

Biosimilars/General | Posted 04/06/2021

Biosimilars are becoming more important around the world and Korean companies, such as Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture), are fast becoming major players both in Korea but also worldwide.