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Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial

Biosimilars/News | Posted 13/12/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved Qletli, an adalimumab copy biological. The NMPA has also approved the Investigational New Drug (IND) application from Bio-Thera Solutions (Bio-Thera) to initiate a phase I clinical study for the proposed ustekinumab copy biological BAT2206.

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Australia approves five biosimilars since June 2019

Biosimilars/News | Posted 06/12/2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has approved five biosimilars since June 2019. The biosimilars approved in the country since then include three pegfilgrastim biosimilars, a trastuzumab biosimilar and a bevacizumab biosimilar.

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Phase III trials started for bevacizumab and natalizumab biosimilars

Biosimilars/News | Posted 06/12/2019

Phase III trials have started for proposed biosimilars of bevacizumab and natalizumab.

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EC approval for subcutaneous infliximab biosimilar Remsima SC

Biosimilars/News | Posted 29/11/2019

South Korean biotechnology company Celltrion Healthcare (Celltrion) announced on 26 November 2019 that it had received European Commission (EC) approval for the subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

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Lupin to launch etanercept and pegfilgrastim biosimilars in the US

Biosimilars/News | Posted 29/11/2019

India-based generics maker Lupin, which is expecting European approval for its etanercept biosimilar in March 2020, has announced plans to launch the drug on the US market soon after, alongside a pegfilgrastim biosimilar.

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FDA approves adalimumab biosimilar Abrilada

Biosimilars/News | Posted 22/11/2019

US-based pharma giant Pfizer announced on 18 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (PF 06410293).

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Qilu starts phase III trial for denosumab copy biological

Biosimilars/News | Posted 22/11/2019

Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu) is carrying out a phase III clinical trial for a copy biological of Amgen’s Prolia/Xgeva (denosumab).

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Adalimumab copy biological accepted for review in China

Biosimilars/News | Posted 15/11/2019

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.

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Teriparatide biosimilar Terrosa launched in Europe

Biosimilars/News | Posted 06/09/2019

Hungary-based Gedeon Richter (Richter) announced on 20 August 2019 that it had launched its teriparatide biosimilar Terrosa in Europe immediately following the patent expiry of the reference product in August 2019.

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FDA approves pegfilgrastim biosimilar Ziextenzo

Biosimilars/News | Posted 08/11/2019

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).

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Tanvex BioPharma’s filgrastim biosimilar comes under fire

Biosimilars/News | Posted 08/11/2019

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.

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Bevacizumab ‘similar biologic’ Versavo launched in India

Biosimilars/News | Posted 08/11/2019

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.

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EMA approval for Pegfilgrastim Mundipharma

Biosimilars/News | Posted 25/10/2019

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.

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Russian approval for non-originator dornase alfa

Biosimilars/News | Posted 18/10/2019

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).

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FDA approves Pfenex’s follow-on teriparatide product

Biosimilars/News | Posted 11/10/2019

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).

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Biocon/Mylan launch first insulin glargine biosimilar in Australia

Biosimilars/News | Posted 11/10/2019

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).

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Three darbepoetin alfa biosimilars approved in Japan

Biosimilars/News | Posted 04/10/2019

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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iBio and CC-Pharming collaborate for rituximab copy biological in China

Biosimilars/News | Posted 04/10/2019

Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, announced on 27 August 2019 that it will expand its collaboration with China-based CC-Pharming for a rituximab copy biological in China.

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Positive EMA-CHMP opinion for SC infliximab biosimilar

Biosimilars/News | Posted 27/09/2019

South Korean biotechnology company Celltrion announced on 22 September 2019 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended for approval the company’s subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

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Samsung Bioepis to supply Brenzys to Brazil under production development partnership

Biosimilars/News | Posted 27/09/2019

On 10 September 2019, Samsung Bioepis announced that it had signed a productive development partnership (PDP) with Brazil’s Ministry of Health to supply Brenzys, a similar biotherapeutic product to rheumatoid arthritis treatment Enbrel (etanercept), to Brazil for the next 10 years.