Biosimilars/General

Recommendations published by Canadian breast cancer advocacy group

Biosimilars/General | Posted 24/05/2019

In April 2019, an advocacy group for patients with breast cancer in Canada – the Canadian Breast Cancer Network (CBCN) - published recommendations related to use of biosimilars in a white paper, entitled ‘Breast Cancer & Biosimilars Recommendations on Use, Implementation and Patient Communications’. These recommendations were informed by insights collected from virtual roundtable discussions with patients and medical oncologists.

Canadian organizations collaborate to improve biosimilar adoption in cancer and inflammatory rheumatic and bowel disease

Biosimilars/General | Posted 17/05/2019

With a number of biosimilars expected to launch in Canada in 2019 and beyond, Canadian organizations are collaborating to improve biosimilar adoption. Canada lags behind the European Union in terms of approval and uptake of biosimilars [1].

Patient and provider views on biosimilars to treat breast cancer

Biosimilars/General | Posted 10/05/2019

A Canadian breast cancer advocacy group collected insights from patients and medical oncologists regarding the use of biosimilar treatments.

FDA to hold public meeting on access to affordable insulin

Biosimilars/General | Posted 26/04/2019

The US Food and Drug Administration (FDA) is seeking input on the challenges and opportunities the agency should consider as it prepares for the submission and review of applications for biosimilar and interchangeable insulin products, as well as about the development process for such products.

Eli Lilly to introduce half-price authorized insulin biosimilar in US

Biosimilars/General | Posted 19/04/2019

With high drug prices increasingly coming into the spotlight, Eli Lilly has announced that it will introduce a lower-priced authorized biosimilar version of its diabetes treatment Humalog (insulin lispro) in the US.

Biocad advancing its non-originator biologicals in Russia

Biosimilars/General | Posted 12/04/2019

Russian biotechnology company Biocad has started an eculizumab study and has also registered its non-originator biological (BCD 057) in Russia.

What happened in biosimilars during 2014

Biosimilars/General | Posted 06/03/2015

Many new developments have taken place in the biosimilars industry in 2014 [1]. One of the most important milestones during 2014 was the news that the US Food and Drug Administration (FDA) had accepted several biosimilars applications, and had even recommended the approval of Sandoz’s filgrastim biosimilar in all five indications of the originator product (Neupogen).

Biosimilars applications under review by EMA – December 2014

Biosimilars/General | Posted 30/01/2015

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.

Biosimilars of somatropin

Biosimilars/General | Posted 01/04/2019

Somatropin or human growth hormone (hGH) is a peptide hormone that stimulates growth, cell reproduction and cell regeneration in humans and other animals. It is thus important in human development. It is a type of mitogen which is specific only to certain kinds of cells. Growth hormone is a 191-amino acid, single-chain polypeptide that is synthesized, stored and secreted by somatotropic cells within the lateral wings of the anterior pituitary gland.

Biosimilars of pertuzumab

Biosimilars/General | Posted 05/04/2019

Pertuzumab is a monoclonal antibody that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, which prevents them from signalling in ways that promote cell growth and proliferation.