Biosimilars/General
FDA to hold public meeting on access to affordable insulin
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
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
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
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
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
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
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.
Samsung Bioepis invalidates Herceptin patent in Korea
Samsung Bioepis has won a patent invalidation suit against Roche’s Herceptin in Korea.
Celltrion wins biosimilar deals and Duopharma increases focus on biosimilars in SE Asia
Celltrion Healthcare (Celltrion) has won tenders to supply infliximab to Singapore and rituximab to Thailand, while CCM Duopharma Biotech Bhd (CCMD) aims to increase revenue contribution from its biosimilar products from 22% to over 25%.
Pfizer drops five preclinical biosimilar programmes
US pharma giant Pfizer confirmed on 15 January 2019 that it had terminated five of its preclinical biosimilar programmes after looking at the results of the company’s annual investment review.
