Biosimilars
Epirus and Ranbaxy sign agreement for infliximab 'similar biologic'
Epirus Switzerland, a subsidiary of US-based Epirus Biopharmaceuticals, and India-based Ranbaxy Laboratories (Ranbaxy) announced on 9 January 2013 that the two companies had signed a licensing agreement for BOW015, an infliximab biosimilar.
Improving access to HCV treatment in developing countries
Hepatitis C virus (HCV) infection affects 150–180 million people worldwide each year, killing an estimated 350,000. The considerable cost of treatment – US$ 10,000–US$20,000 per patient for a 48-week course – presents an insurmountable barrier in developing countries, where the disease burden is greatest. Barbara Milani and Sara Gaspani of Médecins Sans Frontières, Geneva, Switzerland, have collected information on biosimilars and other alternatives to the current recommended treatment, pegylated interferon alpha (in combination with ribavirin) [1]. With these findings, they hope to accelerate the search for feasible, accessible alternatives to current therapies.
Biologicals sales quadruple from 2002 to 2017
Biologicals are outstripping regular pharmaceuticals in terms of growth and taking a bigger and bigger chunk of overall drug sales. Increasingly, biosimilars and non-originator biologicals are also taking a small share of this market.
Biosimilars approved in Canada
Last update: 6 August 2024
In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada.
FDA to review insulin biosimilar
Eli Lilly and Boehringer Ingelheim announced on 20 December 2013 that the US Food and Drug Administration (FDA) had accepted their New Drug Application (NDA) for a biosimilar insulin product.
Biosimilars developments during 2013
Last update: 12 February 2014
The past year has been a busy one for the biosimilars’ industry. One of the most important milestones during 2013 was the European approval of the first monoclonal antibody biosimilar infliximab [Remsima/Inflectra] made as a collaboration by South Korean biotechnology company Celltrion and US-based generics major Hospira [1]. Celltrion has also gained approval for Remsima in South Korea [2] and Colombia [3], and has also applied for approval in Japan [4]. In fact, in Europe, the European Medicines Agency (EMA) has been busy during 2013 approving five biosimilars [5, 6].
Trastuzumab ‘similar biologic’ to be launched in India
India-based Biocon announced on 18 January 2013 that it was introducing its trastuzumab ‘similar biologic’ CANMAb to the Indian market.
Immunogenicity testing in biosimilars
During a presentation given by Dr Kelly Colletti (Laboratory Sciences, USA) at an international conference on biowaivers and biosimilars, held in the US in September 2012, it was discussed whether one or two assays should be employed in order to measure anti-drug antibodies to both the biosimilar and reference biological in a comparative manner [1].
Alvotech invests US$250 million in biosimilars
Iceland-based biopharmaceutical company Alvotech announced on 5 December 2013 that it would invest US$250 million to build a plant in Reykjavik for the development and manufacture of a portfolio of biosimilar monoclonal antibodies.
Biosimilar trastuzumab approved in Korea
South Korean biotechnology company Celltrion announced on 15 January 2014 that it had received approval for its biosimilar monoclonal antibody Herzuma (trastuzumab) with the Korean Ministry of Food and Drug Safety (MFDS, formerly Korea Food and Drug Administration).
