Biosimilars/News
Darbepoetin alfa ‘similar biologic’ launched in India
India-based Hetero, one of the largest manufacturers and suppliers of active pharmaceutical ingredients (APIs) to the Indian pharmaceutical industry, announced on 18 June 2014 the launch of its first ‘similar biologic’ product Actorise, a ‘similar biologic’ of darbepoetin alfa in India.
Rituximab similar biologic launched in India
India-based generics maker Hetero Group (Hetero) announced on 3 August 2015 the launch of its product Maball, a ‘similar biologic’ of rituximab, in India.
Non-originator infliximab approved in Russia
South Korean biotechnology company Celltrion announced that it had received approval for its non-originator infliximab, Remsima, from Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav) on 13 July 2015.
Biosimilars licensing agreements for AMP and Formycon
German biosimilars companies AMP Biosimilars (AMP) and Formycon have both made out-licensing agreements for their candidate biosimilars.
Ranibizumab similar biologic launched in India
Indian generics maker Intas Pharmaceuticals (Intas) announced on 19 June 2015 the launch of its ranibizumab similar biologic in India.
Indian drugmakers make progress with candidate biosimilars
India-based biologicals specialist Biocon announced on 7 May 2015 that it had made clinical progress in its partnered programmes with US generics maker Mylan.
Baxter and Coherus amend biosimilar etanercept collaboration
US-based biosimilars developer Coherus BioSciences (Coherus) and Baxter International (Baxter) announced on 15 April 2015 that they had amended some of the financial terms of their collaboration agreement for CHS-0214, an etanercept biosimilar candidate.
Latin American deal for infliximab biosimilar
US-based Epirus Biopharmaceuticals (Epirus) announced on 14 May 2015 that it had made a deal with biosimilars specialist mAbxience, a subsidiary of Spanish healthcare firm the Chemo Group, for Latin America with respect to the infliximab biosimilar made by Epirus.
Australian approval for biosimilar insulin
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has given a positive recommendation for the listing of Eli Lilly’s biosimilar insulin glargine, Basaglar in the country’s Pharmaceutical Benefits Scheme (PBS). Basaglar is the first biosimilar insulin to be approved in Australia, providing an alternative, affordable treatment option for patients suffering from diabetes.
Iran approves its first rituximab biogeneric
In May 2015, Iran’s National Regulatory Authority, the Food and Drug Organization (FDO), approved its first rituximab biogeneric (Zytux). The medicine received its marketing authorization based on the previously published national guideline for marketing of biogenerics in Iran [1].
