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Celgene settles Revlimid patent litigation with Natco Pharma

Celgene Corporation (Celgene) is to provide India-based Natco Pharma and its US partner, Arrow International – a unit of Allergan – the license to manufacture and market generic Revlimid (lenalidomide) in the US from 31 January 2026, following expiration of patents in the US in April 2017. This will expedite generics competition for the drug, which currently makes up 60% of Celgene’s annual revenue.

Australian approval for infertility biosimilar Bemfola

Switzerland-based Finox Biotech (Finox) announced on 30 November 2015 that it had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for follitropin alfa biosimilar Bemfola.

Filgrastim follow-on biological approved in Brazil

Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 20 October 2015 that it had approved the follow-on biological medicine Fiprima (filgrastim).

Bevacizumab non-originator biological approved in Russia

Russian biotechnology company Biocad announced on 30 November 2015 that the Russian Ministry of Health had approved the company’s bevacizumab non-originator biological drug, BCD-021. The drug is a non-originator biological of Roche’s cancer blockbuster Avastin (bevacizumab).

EMA accepts application for etanercept biosimilar

Sandoz, the generics division of Novartis, announced on 8 December 2015 that the regulatory submission for its proposed etanercept biosimilar (GP2015) had been accepted by the European Medicines Agency (EMA).

FDA approves first follow-on insulin glargine treatment

The US Food and Drug Administration (FDA) announced on 16 December 2015 that it had approved Eli Lilly/Boehringer Ingelheim’s biosimilar version of Sanofi’s Lantus (insulin glargine) diabetes treatment.

Korean approval for infliximab biosimilar

Samsung Bioepis and partner Merck announced on 4 December 2015 that Samsung Bioepsis had received approval for its infliximab biosimilar Renflexis from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Biosimilar adalimumab application submitted to EMA

Biotech giant Amgen announced on 4 December 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the European Medicines Agency (EMA).

FDA accepts application for pegfilgrastim biosimilar

Sandoz, the generics division of Novartis, announced on 18 November 2015 that its regulatory submission for its proposed pegfilgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).

Infliximab price wars

Merck has reportedly slashed the price of its blockbuster Remicade (Infliximab) in the UK in order to fight off growing competition from infliximab biosimilars.