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EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan

India-based biologicals specialist Biocon and US-based partner Mylan announced on 1 December 2017 that the applications for approval for their proposed pegfilgrastim (MYL‑1401H) and trastuzumab (MYL‑1401O) biosimilars have been accepted by the European Medicines Agency (EMA).

EC approval for trastuzumab biosimilar Ontruzant

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 20 November 2017 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Ontruzant (SB3).

South Africa approves first non-originator biological

South Africa’s Medicines Control Council (MCC) has approved the country’s first non-originator biological, filgrastim, from Teva Pharmaceutical Industries (Teva).

EMA approval for bevacizumab biosimilar Mvasi

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 10 November 2017 that it had recommended granting marketing authorization for the bevacizumab biosimilar Mvasi.

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.