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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.

Biosimilar infliximab offered to French hospitals at 45% discount

A major French hospital group has chosen biosimilar infliximab to treat its patients with rheumatoid arthritis, Crohn’s disease and psoriasis, after major discounts on the drug were offered to the group.

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.

FDA approves first once-daily glatirimer acetate generic

The US Food and Drug Administration (FDA) announced on 16 April 2015 the approval of the first generic version of glatiramer acetate injection, used to treat patients with relapsing forms of multiple sclerosis (MS).

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].

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