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Adalimumab copy biological accepted for review in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of adalimumab copy biological UBP1211.

Phase I trials started for aflibercept and ustekinumab biosimilars

Phase I trials have started for proposed biosimilars of aflibercept and ustekinumab.

South Korean biologicals company Alteogen has, according to clinicaltrials.gov, started a phase I trial for its candidate aflibercept biosimilar ALT-L9.

FDA approves pegfilgrastim biosimilar Ziextenzo

Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Ziextenzo (LA-EP2006).

Tanvex BioPharma’s filgrastim biosimilar comes under fire

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) is having a rough time lately. In July 2019, Amgen filed an infringement lawsuit against the company regarding its filgrastim biosimilar, TX01. Then in September 2019, US Food and Drug Administration (FDA) rejected Tanvex’s application for approval of TX01.

Bevacizumab ‘similar biologic’ Versavo launched in India

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 19 August 2019 that it had launched its bevacizumab ‘similar biologic’, Versavo (DRZ_BZ) in India.

EMA approval for Pegfilgrastim Mundipharma

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2019 that it had recommended granting of a marketing authorization for the pegfilgrastim biosimilar Pegfilgrastim Mundipharma.

Russian approval for non-originator dornase alfa

Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 17 September 2019 that the Russian Ministry of Health had approved their dornase alfa non-originator biological drug, Tigerase. The drug is a non-originator biological of Roche’s Pulmozyme (dornase alfa).

FDA approves Pfenex’s follow-on teriparatide product

US-based biotech firm Pfenex announced on 7 October 2019 that it had received approval from the US Food and Drug Administration (FDA) for its follow-on teriparatide product (PF708).

Biocon/Mylan launch first insulin glargine biosimilar in Australia

India-based biologicals specialist Biocon and US-based partner Mylan announced on 3 October 2019 the launch of the first insulin glargine biosimilar in Australia available on the Pharmaceutical Benefits Scheme (PBS).

Three darbepoetin alfa biosimilars approved in Japan

Three pharmaceutical companies have announced approval of their anaemia treatments for sale on the Japanese market, while Mochida reveals it will sell the first teriparatide biosimilar in the country.

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