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EC approval for adalimumab biosimilar Cyltezo

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer) announced on 13 November 2017 that it had received European Commission (EC) approval for its biosimilar adalimumab product Cyltezo (BI 695501).

Adalimumab and trastuzumab biosimilars approved in South Korea

South Korean biosimilars maker Samsung Bioepis announced on 9 November 2017 that it had received marketing approval for its biosimilar version of Roche’s blockbuster breast cancer therapy Herceptin (trastuzumab) from Korea’s Ministry of Food and Drug Safety (MFDS). The news follows another announcement by the company on 22 September 2017 that it had also gained approval for its adalimumab biosimilar (SB5).

Humira deal could cost CMS US$1.48 billion

The settlement deal made between US-based biotech giant Amgen and pharma giant AbbVie regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab) could cost the US Centers of Medicare and Medicaid (CMS) at least US$1.48 billion.

EMA accepts biosimilar pegfilgrastim application from Sandoz

Sandoz, the generics division of Novartis, announced on 27 October 2017 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).

Novo Nordisk petitions FDA to require clinical trials for Victoza biosimilars

Danish pharmaceutical company Novo Nordisk has asked the US Food and Drug Administration (FDA) to require clinical trials for biosimilar applications for its blockbuster diabetes drug Victoza (liraglutide).

FDA delays approval of Biocon/Mylan’s pegfilgrastim biosimilar

India-based biologicals specialist Biocon announced on 10 October 2017 that it has been informed by the US Food and Drug Administration (FDA) that its pegfilgrastim biosimilar, which it is developing jointly with Mylan, cannot be approved at present.

Amgen’s adalimumab biosimilar will only be launched in US in 2023

US-based biotech giant Amgen and pharma giant AbbVie announced on 28 September 2017 that they had reached a ‘global resolution’ ending all patent litigation regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab).

EMA accepts application for pegfilgrastim biosimilar from Cinfa

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 4 October 2017 that its application for approval for its proposed pegfilgrastim biosimilar (B12019) had been accepted by the European Medicines Agency (EMA).

Nichi-Iko gains Japanese approval for infliximab biosimilar

Japan-based generics maker Nichi-Iko Pharmaceutical (Nichi-Iko) announced on 27 September 2017 that it had gained Japanese approval for its infliximab biosimilar.

JCR files for Japanese approval of agalsidase beta biosimilar

Japan-based JCR Pharmaceuticals (JCR) announced on 29 September 2017 that it had applied for Japanese regulatory approval for its agalsidase beta biosimilar (JR‑051).