Pharma News
Top 10 most read GaBI Online articles in 2018
A review of the important events for biosimilars during 2018 are presented in this article. Some of the most memorable events for biosimilars in 2018 were the rejections by the US Food and Drug Administration (FDA) of four biosimilars and the agency’s update on its naming guideline for biologicals. Other subjects of interest for biosimilars were European Medicines Agency approvals, the US biosimilars market, biosimilar policies in Europe, position statements on biosimilars and interchangeability and switching.
Samsung BioLogics sues Korea’s FSC over accounting discrepancies
Samsung BioLogics is fighting back against allegations of accounting fraud and has launched a lawsuit against the South Korean financial authority, the Financial Services Commission (FSC).
Health care in Iraq saves money by incorporating off-patent biologicals
Iraq is one of many countries determined to increase its budget savings by replacing appropriate originator biologicals with off-patent biologicals. This is due to the recognition of the proven impact off-patent biologicals have on the financial burden of healthcare systems worldwide [1, 2].
Alvotech makes deal with Fuji Pharma for biosimilars in Japan
Iceland-based biopharmaceutical company Alvotech and Japan-based Fuji Pharma announced on 19 November 2018 that they had entered into an exclusive partnership for biosimilars in Japan.
Amgen collaborates with Orion to market Amgevita in Finland
The Orion Group announced on 24 October 2018 that it will distribute Amgen’s adalimumab biosimilar in Finland.
Biosimilar partnerships for Alvotech and Pall Biotech
Partnering to develop biosimilars is still in vogue. The latest companies to join the trend include Alvotech with Changchun High & New Technology Industries Group (CCHN) and Pall Corporation’s Biotech business (Pall Biotech) with Aetos Biologics.
Mundipharma buys Spanish biosimilars maker Cinfa Biotech
UK-based Mundipharma International (Mundipharma) is strengthening its position in biosimilars with the acquisition of Spanish biosimilars maker Cinfa Biotech.
MENA mAb manufacturer AryoGen receives EU GMP approval
Iran-based AryoGen Pharmed (AryoGen) has received a Good Manufacturing Practice (GMP) certificate from the European Medicines Agency (EMA), becoming one of the first monoclonal antibody (mAb) manufacturers in the Middle East and North Africa (MENA) region to be certified [1].
Co-development deal for ranibizumab biosimilar Xlucane
German generics giant Stada and Swedish biotech company Xbrane announced on 12 July 2018 that they had entered into a co-development agreement for Xlucane, a proposed biosimilar to Lucentis (ranibizumab).
AbbVie signs another licensing deal for adalimumab biosimilar
US-based pharma giant AbbVie has signed yet another licensing deal for a biosimilar version of its blockbuster arthritis drug Humira (adalimumab).
